An intervention for parents with severe personality difficulties whose children have mental health problems: a feasibility RCT

Analysis

Seventy-one identified research papers were scrutinised for relevant findings, charted and sorted according to the MWG TIDieR checklist. The review synthesis did not seek to assess the quality of evidence or to determine the generalisability of findings. 93–95

Characteristics of the target population

As outlined in Chapter 1, personality disorders are associated with substantial behavioural, emotional, social and cognitive impairments of parenting. They are also associated with significant personal, social and economic adversity, both current and past, that is likely to undermine parental competence and parenting capacity. 6,20–23 Parents affected by personality disorders are more frequently exposed to negative life events. 96

People affected by personality disorders more frequently experience feelings of alienation from services, which leads to disengagement and being more likely to be subject to negative staff attitudes and behaviours. 97–99 As a result of interpersonal difficulties, poor impulse control, instability, relationship conflict and multiple life problems, people affected with personality disorders may feel antagonistic, avoidant and reluctant to engage with services. They may attribute their difficulties to factors that are outside their control, and have low self-belief and efficacy as well as having few reliable social and family resources.

Helping Families Programme conceptual model and intervention rationale

The Multiple Determinants of Parenting (MDP) conceptual model100 is a well-established framework that specifies how the interaction between child characteristics and parenting is influenced by the multiple impacts of parents’ personality, couple relations, family and social networks and work experiences (Figure 1). According to the model, parents’ own proximal and distal developmental history shapes their personality including behaviour, cognition, attitudes, values, emotional regulation and coping. The MDP model illustrates the central role that parenting has in influencing child outcomes as well as its role in mediating the effects of other parent factors that influence child outcomes.

FIGURE 1.

Modified multiple determinants of parenting model.

Additional factors, identified since the initial development of the MDP conceptual model, that may have particular salience for parents with severe personality difficulties include the impact and transmission of heritable characteristics and the multiple impacts across the MDP model of coexisting mental health and substance use problems.

The MDP model offered a useful conceptual framework to underpin the HFP-M because:

• The genetic transmission of some personality disorder characteristics may increase children’s inherent vulnerability to developing prodromal personality difficulties and other mental health problems. 101

• The persistent, pervasive and problematic interpersonal difficulties associated with personality disorders are likely to have a direct effect on the child’s parenting environment. 14,16,20,30

• Parents affected by a personality disorder are at increased risk of parenting behaviours, emotional regulation, interactions and relationships, and cognition, that have a detrimental impact on child outcomes. These include harsh, neglectful and abusive parenting practices; emotional hostility and intrusiveness; critical, dismissive and intrusive interaction; inconsistent and unpredictable parental routines, responses and reactions; over-involvement and protectiveness; and difficulties in accurately identifying and responding sensitively to children’s emotional and developmental needs. 31–49

• Parents affected by severe personality difficulties may be aware of normative, positive parenting but their efforts may be undermined by their personality and interpersonal functioning. 49

• Parents affected by personality disorders are at an increased risk of coexisting mental health conditions, particularly depression and substance misuse. 17,19,24–26

• Parents themselves may have developmental histories characterised by poor attachment, neglect and life crises. 6,21,23

• Personality disorders are associated with personal, social and economic adversity including interpersonal conflict, intimate partner and other violence, lone parenthood, social isolation, worklessness and insecure employment. 24,93,102

Organisation and intervention delivery

The organised provision of parenting interventions is heterogeneous and it occurs across multiple types of services. 103 Parents often value community-based provision. Practitioner qualification level and type varies considerably across delivery. Practitioner skill level may improve parent initial engagement, continuing intervention participation and outcome. 104

Challenges for staff working with service users affected by personality disorders are well documented. 105 Regular supervision for staff is an integral part of specialist therapies designed for service users affected by personality disorders. 106,107

Although implementation is inconsistent, family-focused approaches in adult mental health services are advocated to improve the engagement of hard-to-reach parents and families. 28 CAMHS tend to focus on the needs of children and do not frequently integrate the treatment of parental mental health difficulties into routine provision.

Service attendance may be affected by service users’ greater exposure to adverse life events and their response to them. 96

Routine service and clinician engagement and social marketing

Personality disorders are associated with known stigma, pejorative clinician beliefs and an expectancy to receive negative treatment. Adult mental health practitioners have concerns that discussing children’s difficulties with parent service users may detrimentally affect their mental health and may lead to increased service use. 108 Conversely, clinicians are also concerned that discussion of parenting may discomfort parents and lead to therapeutic disengagement. 109

Clinicians expressed reservations about the intervention effectiveness for this target population and were concerned about additional burdens of case management that may result from multiple service involvement. 110

Identification of potential intervention recipients and research participants

Accurate identification of parental mental health difficulties within child mental health care and the identification of child emotional and behavioural problems within adult mental health services varies considerably. It may depend on individual clinician characteristics, such as perceived role, confidence and competence rather than operational procedures. 108,109,111

Practitioner concerns about diagnosing personality disorders are well documented. 110 Many adult mental health staff members have not undertaken training in child development and the assessment and treatment of child mental health difficulties.

Well-established, psychometrically robust screening instruments are available to identify personality disorders and child mental health disorders. For example, the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), Axis II Disorders (SCID-II) is a gold standard tool for the diagnosis of personality disorders. 112 Inter-rater reliability scores for the SCID-II are excellent,113 with no significant differences between experienced and recently trained interviewers. 114 The Standardised Assessment of Personality – Abbreviated Scale (SAPAS) is a very brief interviewer-administered, structured screening tool designed to identify individuals with a potential personality disorder. 115 It does not screen for specific subtypes of personality disorders; rather, increasing scores indicate increasing likelihood that an individual has any personality disorder.

Candidate screening tools for child mental disorders include the Development and Well-Being Assessment (DAWBA), intended for children aged 5–16 years. The Pre-School Age Psychiatric Assessment (PAPA) can be used for children aged 3–4 years. Both are well-validated standardised tools completed by interview or computer for assessing child emotional and behavioural disorders. 116,117 The DAWBA covers common emotional, behavioural and hyperactivity disorders without neglecting less, but sometimes more severe, disorders. The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire for 3- to 16-year-olds that is used extensively to identify common mental health problems. 118 The 25 items are divided between five scales that measure emotional, conduct, hyperactivity/inattention and peer relationship problems together with prosocial behaviour.

Engagement of service users and their interest in Helping Families Programme-Modified and its research evaluation

Time demands, flexibility and scheduling concerns are a significant barrier to participation in parenting programmes. 119 Parent and children involvement in concurrent intensive mental health, health, social care and education appointments may hinder participation.

Treatment trial participants have expressed concerns about (1) the burden of assessments and research procedures, (2) participation in interventions with unproven effects and (3) poor quality of information about potential risks and benefits. 120

Some parent service users may be reluctant to be open about difficulties, owing to fears about involvement of child protection services. 104

Case co-ordination and integration of Helping Families Programme-Modified with treatment as usual

A large-scale systematic review of trial data suggested that treatment as usual was often poorly defined and highly variable for service users affected by personality disorders. 119 Evidence from RCTs showed that better planned and organised non-specialist treatments may be comparable in effect to specialist treatments for people with borderline personality disorder. 121–125 Effective components may include experienced therapists, supportive therapeutic process, life problem focus, non-intensive format and case management integration.

Consistent with good standards of clinical practice, evidence suggests that research clinicians should retain ongoing contact with referring practitioners. Evidence from research trials showed that changes in participant functioning are important to communicate to routine services and failure to do so may have negative consequences for care co-ordination. 120

Intervention format

Session number and frequency of parenting programmes vary. Commonly, between 8 and 12 sessions and up to 16 weekly sessions can be provided. 51,54 Individualised programme formats are often superior for families with complex psychosocial needs. 51

Barriers to parenting programme participation include location accessibility, parent treatment expectancies and intervention burden. 126 Some parents are discouraged by longer programmes, whereas others are willing to engage in longer programmes when there is a known benefit. 127,128

For either format, structured, focused, meaningful content including practical activities and written information will probably increase parent engagement. 129 The volume of intersession activity undertaken by participants of parenting programmes does not appear to predict larger ESs for child outcomes and parenting skills. 130 Parents’ actual use of positive parenting techniques with their child has been found to predict larger ESs for child behavioural problems and parenting skills. 130

Evidence-based interventions for personality disorders tend to be delivered over extended time periods. 131

Intervention content

Parenting programmes are usually designed according to children’s developmental stages, with parenting content tailored accordingly. Programmes addressing wide developmental ranges are uncommon. Significant reductions in child behavioural difficulties have been widely demonstrated in studies involving parents of children aged 3–11 years. 51,132 Though feasible for parents with adolescents, the evidence base is small and further outcome research is required. 133,134

Much psychosocial treatment evidence for personality disorders is based on interventions for people affected by borderline personality disorder. Intervention characteristics associated with increased effectiveness include structured, goal-orientated methods; information provision and psychoeducational content; focus on managing current life situations; active, responsive and validating therapeutic experiences; active service user participation and agency; and limited therapeutic intensity and therapist consistency. 106,135,136

As described above, parents affected by personality disorders may have impairments across a range of parenting functions. Established parenting programmes typically have a narrow focus on parenting skills, parent–child interaction and communication. 51,137,138 There is generally less focus on therapeutic process, parent engagement and personalisation in many group format programmes. Larger ESs are associated with positive parent–child interactions, developing parent emotional communication skills, learning consistent parental responding, and learning ‘time out’ as a disciplinary skill. 130

Personalising intervention content to individual characteristics is recommended for programmes aimed at families with complex psychosocial needs. 54,55 For example, specialised programmes for depressed parents that include topics to address parental mental health have been found to be effective in modestly improving child outcomes. 54

Intervention fidelity procedures improve the accurate interpretation of manual content and may reduce the influence of possible confounders. 139 Key fidelity components include manualised intervention format, methods and content; intervention training; monitoring intervention delivery; and monitoring of intervention receipt. 140

Participants

Participants were parents with relevant lived experience of personality and child mental health disorders attending the mental health services of SLAM and CNWL. Recruitment used the pre-existing networks of the study investigators and collaborating services using word of mouth, clinician recommendation, posters and leaflets. A total of eight service users, seven females and one male, participated. Participants received an explanation of the aims and purpose of the consultation group prior to attendance and gave written consent for participation and recording.

Format and procedure

Consultation groups were held in service settings familiar to the participants. Each group lasted 60–90 minutes. Moderators sought to create a welcoming and informal atmosphere. Refreshments were available throughout the sessions.

A semistructured format moderated by a service user researcher and a clinical researcher was used to guide participants through an open-ended discussion of the following topics:

• rationale, aims, structure and content of the proposed programme

• methods for introducing the research programme to potential participant parents

• screening and consent methods

• compatibility of parent programme participation alongside other care.

Moderators presented information accompanied by written handouts and PowerPoint^® (Microsoft Corporation, Redmond, WA, USA) slides. Open, exploratory prompts were used to encourage discussion, elicit and clarify service users’ ideas, and develop researcher understanding. Generated findings from the first consultation group were shared with the subsequent group to stimulate and enrich discussion. Groups ended with a summary of the research team’s next steps and a debrief about the participants’ experience.

Analysis

Each consultation group was recorded and transcribed verbatim. Group moderators initially read transcripts together with contemporaneous notes in order to identify generated themes, key recommendations and advice offered by the service user participants. Researchers identified areas of consensus in participant opinions as well as variations.

Service user views were organised in relation to the nine predefined features of the MWG TIDieR checklist. 69 The MWG were responsible for distilling and synthesising findings in conjunction with those from the scoping review and clinician consultation.

Characteristics of the target population and conceptual model

Participants described their lived experience of stigma associated with the term ‘personality disorder’, which most felt would potentially affect engagement in the intervention and research evaluation. There were also some concerns expressed about the development of a ‘special programme for [parents affected by] personality disorder’ [service user (SU) 1] and the potential for activating ‘blame and guilt’ (SU 2) in parents.

Service users raised doubts about whether or not children needed to be already involved with CAMHS in order for their parent to be eligible for the intervention.

Organisation and intervention delivery

Participants highlighted that clinicians delivering the proposed intervention should have a good understanding of personality disorders, their individual effects and the potential personal impact of the proposed psychoeducational programme, for example, ‘. . . they have to have a good understanding of borderline because it is so easy to trigger somebody’ (SU 2).

Service users typically underlined the importance of offering the programme within the context of a ‘trusting therapeutic relationship’ (SU 4) because of the guilt experienced by many parents affected by personality disorders.

Participants gave support to the structural location of the proposed intervention in both child and adult mental health services. Participants expressed some concern about locating it in children’s social care provision.

Routine service and clinician engagement and social marketing

Participants suggested that clinicians should understand the importance of improving support for parents affected by personality disorders but they did not make any specific recommendations about the optimal ways of engaging mental health staff in the research evaluation.

Identification of potential intervention recipients and research participants

Service users questioned the value of relying on clinicians’ judgement in the identification of potentially eligible parents. Some suggested that practitioners may not be knowledgeable about the parenting difficulties experienced by service users.

Participants did not provide feedback on the examples of screening tools shared by the group leaders. These included the Structured Clinical Interviews for DSM-IV Axis II Disorders (SCID-II), the SAPAS, the DAWBA and the SDQ. However, they raised a broader concern that parents ‘wouldn’t necessarily give all their information at once’ (SU 3), suggesting that the accuracy in referral and screening processes may vary accordingly.

Participants felt that identification, engagement and access to the intervention would be easier when a parent was already ‘in the system’ (SU 3) as an identified service user.

Engagement of service users and their interest in the Helping Families Programme-Modified and its research evaluation

Service users felt that the primary motivation for parents to participate in the intervention was to help and support their children. Engagement was likely to be affected by parents’ level of awareness of the impact of their own mental health difficulties on their parenting and on the outcomes of their child. Parent engagement may be greater when it is focused on ‘what you can do, rather than what you haven’t done’ (SU 7) as a parent.

Participants felt that parents would be highly sensitive to clinicians’ use of ‘judgemental’ (SU 8) language. They recommended that the offer to participate in research should be introduced by a practitioner whom the parent trusted. Participants advocated a ‘softly, softly’ (SU 1) approach that avoided activating parents’ underlying guilt. Service users expressed concerns about the involvement of children’s social services ‘at any stage’ (SU 7).

Participants promoted the importance of clear, non-patronising, plain English explanations of the intervention and research that were tailored to the needs of the individual and their circumstances with ‘no therapy speak or ‘psychobabble’ (SU 1).

Case co-ordination and integration of Helping Families Programme-Modified with usual care

Participants held differing views about participation in the proposed intervention alongside attending existing treatment services. Some service users felt that it could be ‘overwhelming and confusing’ (SU 3), whereas others felt that it should be determined by the needs and the resilience of the individual service user, and the frequency of attendance and the emotional intensity of other interventions. For example, some day care services for people affected by personality disorders require multiple attendances each week and can be ‘emotionally demanding’ (SU 8). However, ‘just seeing a psychologist for an hour a week as well as taking part in a parenting programme was more manageable’ (SU 7). Consultees felt that parents of younger children and those with other carer responsibilities may find it difficult to consistently attend appointments outside their home.

Service users advocated the inclusion of crisis plans in case co-ordination so that programme participants would know whom to contact between appointments and in the event of emergencies.

Service users were uncertain about what constituted treatment as usual for parents affected by personality disorders, with one commenting that ‘there isn’t a lot of support out there for me yet’ (SU 6).

Intervention format

Service users advocated a flexible approach to programme delivery and duration that was tailored to individual needs. For example, additional sessions may be required to take account of some parents ‘going at a slower pace, depending on how they have received the therapy’ (SU 1). Programme delivery would also need to be adjusted to account for parents’ other commitments, such as school holidays and other medical and school appointments. The option of receiving ongoing telephone support as part of the psychoeducational programme was considered useful.

Participants recommended several strategies for retaining parents’ participation in the proposed programme. These included therapists ‘having a very good understanding of the issues that affect people with personality disorder’ (SU 2), building ‘effective partnerships with parents’ (SU 7), reflecting on ‘parents’ past achievements’ (SU 4), ‘working at the parent’s pace’ (SU 1), ‘having a very good understanding of the parent’s issues in order to be realistic and use incremental goal-setting’ (SU 1) and ‘encouraging and being patient in supporting the parent in their goals’ (SU 2). Service users also recommended that intervention participants should be able to change therapists, if necessary.

Intervention content

Participants considered that a parenting programme based on a psychoeducational approach would be welcomed and would be likely to increase participants’ self-awareness, reflection and skills acquisition, particularly when tailored to an individual's needs and experiences associated with the personality disorder. Given the anticipated complexity of participants’ lives, service users felt that programme delivery would inevitably require ‘a balance between a “therapeutic element” and directing service users back to the parenting’ (SU 3).

An overly didactic, expert approach that relied on instructing parents what to do risked alienating parents and inducing negative reactions. For example, one parent said ‘I already feel guilty because I do know the list of strategies, I do know I am meant to be ignoring, rewarding, doing this doing that, but because of where I am in my depression or where I am with my disorder it means I can’t always draw upon those skills. It feels even worse. So, I don’t know how you solve that, but I just think “no”, I don’t want another list. Sorry.’ (SU 3).

A more collaborative approach based on shared understanding, respect and problem-solving was considered to be a more effective way of engaging parents. Participants felt that therapists should show flexibility in relation to the specific parenting strategies contained in the programme content. These should be tailored to individual parents’ knowledge, experience and circumstances, taking into account ‘what has and hasn’t worked in the past’ (SU 1).

Participants advocated the inclusion of programme content that focused on managing crises, for example the HFP-M Firefighting module. However, participants did recognise the challenges of using such methods when ‘a parent is stuck in a crisis’ (SU 2).

Descriptions of the methods, contents and materials of the HFP Parenting Groundwork and Parenting Strategies content received positive support, particularly topics which focused on forming a positive relationship with your child, understanding a child’s perspective, having fun with your child, boundaries, and learning how to play with your child.

Service users felt that care should reflect and be tailored to the needs of the individual. They did not make explicit recommendations about the best ways that clinicians could maintain the fidelity of specific intervention methods.

Participants

Participants were all clinicians and managers working in mental health services across the two sites. Twenty-six participants were recruited through existing service networks using word of mouth, peer recommendations and e-mail invitations to team leaders. Participants received an explanation of the aims of the consultation and gave written consent for participation and audio-recording.

Format and procedure

The consultation groups were held in routine service settings. The sessions lasted between 60 and 90 minutes. Refreshments were available throughout the sessions. Each group used a semistructured format moderated by researchers (DM and Ruth Wilson) covering the same topics as the service user consultation groups. After creating a welcoming and informal atmosphere, moderators led participants through an open-ended discussion of key topics derived from the TIDieR checklist. Moderators presented information accompanied by handouts and PowerPoint slides. The groups ended with a summary of the research team’s next steps and a debrief about the participants’ experience of the consultation group.

Analysis

The same procedures as the service user consultation groups were used to identify key themes, recommendations and advice offered by service consultees, which were then categorised into the nine predefined features of the MWG checklist. The MWG synthesised these findings with other phase 1 findings.

Characteristics of the target population and conceptual model

Participants considered that research therapists’ management of the interpersonal challenges involved in working with the target population ‘would be key’ (SLAM group 1) to the success of their implementation of the proposed programme.

Supervision was considered to be a crucial support component for the research therapists.

Organisation and intervention delivery

Some staff expressed concerns about ‘helicoptering’ (CNWL group 1) specialist research therapists into routine services to deliver the intervention, as opposed to the provision of the intervention by routine staff. Staff were concerned that poorly co-ordinated care may hinder the transition when involvement in the proposed programme ended and that it may also disrupt existing ‘support networks’ (CNWL group 1).

Staff expressed concerns about ‘bridging the gap’ (CNWL group 1) that often exists between adult and child mental health services. Staff considered that there was equal value in siting the proposed intervention in both child and adult mental health services. Some staff advocated the creation of parental mental health services with a crossover between current adult and child services.

Routine service and clinician engagement and social marketing

Staff felt that ‘there is a need for this intervention’ (SLAM group 2) and could readily identify service users who would meet programme criteria and who would potentially benefit from the intervention. Introductory discussions about the proposed programme would depend on a service clinician’s confidence to talk about children’s difficulties as well as the parents’ own personal difficulties. Competence and confidence to do this varied between practitioners.

Staff recommended the use of individual clinical judgement in raising the programme with parents. They also recommended training sessions on introducing the programme and research evaluation as well as printed information to support initial discussions, including the potential benefits and challenges of participation.

Staff were unsure about how the proposed programme would complement other existing interventions available for the target population. Staff expressed concern about the potentially ‘destabilising effects that may occur’ (SLAM group 1) with parents’ programme participation and the risks that routine service clinicians could be ‘picking up the pieces’ (SLAM group 1).

Identification of potential intervention recipients and research participants

Staff were concerned that the existing structure of services and patient information systems would make it difficult for practitioners to identify eligible families. Child mental health staff were not routinely aware of all parents’ mental health status and service use. Adult mental health staff who were involved would not routinely have information about child mental health status but felt that they would have sufficient information to make recommended referrals. Some existing procedures, such as completion of the SLAM Child Risk Screen, would support initial identification. Identification of potentially eligible families would probably rely on the examination of individual caseloads.

Brief training in identification of eligible families was recommended, as well as further training for adult mental health staff in child and adolescent mental health. Some staff welcomed the use of tools to aid identification of eligible parents, whereas others felt that they could rely on their professional judgement. Positive feedback was given about the SAPAS as a screening tool.

Owing to the difficulties in accessing care, some staff raised concerns about eligibility criteria that required referral and/or attendance at CAMHS.

Engagement of service users and their interest in the Helping Families Programme-Modified and its research evaluation

Participants emphasised the importance of personalised discussions between service clinicians and eligible parents. Clinicians were concerned that parents may be ‘defensive’ (SLAM group 2) about discussing the impact of their own difficulties on their children. They were also concerned about the subsequent adverse effect on their relationships with referred service users. Most of the staff did not want to use a specific script for introducing the research programme but they wanted information sheets and guides that included suggested words and phrasing.

Although introducing the research programme would be easier for parents with existing personality disorder diagnoses, staff raised concerns about whether or not a diagnosis of personality disorder was necessary for inclusion in the programme, particularly given the associated stigma. Concerns were expressed about parents’ ability to distinguish between ‘a research and a clinical diagnosis’ (SLAM group 1) of a personality disorder, the risk of false positives, and the treatment options available for parents identified through the screening process as meeting the criteria for a research diagnosis. This was of particular concern for parent service users without an established personality disorder diagnosis who might be referred from CAMHS and subsequently allocated to a treatment-as-usual condition.

Case co-ordination and integration of Helping Families Programme-Modified with usual care

Staff explained that treatment as usual varied considerably both between and within adult and child mental health services. Staff expressed mixed views about the involvement of programme participants in other intensive interventions. They felt that the programme complemented many other available treatments, although some members of staff were concerned that participation in concurrent treatments may be ‘too much’ (SLAM group 2) and that families may become ‘overloaded’ (CNWL group 1).

Views on case co-ordination for parents involved in the proposed programme varied. Staff advocated an active role for keyworkers to introduce the research therapist to eligible parents. Some staff were concerned that eligible parents may be discharged from routine services once accepted on the research programme. Staff saw the potential for integrating the proposed programme into service user care plans and for it to become part of existing clinical pathways.

Intervention format

Some staff were uncertain about the duration of the proposed programme on the basis that interventions with service users affected by personality disorders may often be of considerable duration. They also thought that considerable time may be required to build effective therapeutic relationships.

Most of the staff advocated delivery of the programme in individual, rather than group, format. They felt that this would increase engagement and personalisation and promote change. Some staff suggested that home-based interventions may be subject to more threats to fidelity that clinic-based treatments.

Intervention content

Participants emphasised the importance of working within the defined and structured approach of the HFP sessions while maintaining some degree of flexibility to optimise engagement and delivery of programme content. Staff supported the use of structured manual content to help parents manage adverse life events and crises. These methods would help participants to focus on immediate needs while recognising that, without careful therapist guidance and boundaries, personal and family crises may become the primary focus of sessions for parents who struggle with impact regulation. Thus, the parenting content may then be missed.

The contents of the HFP Parenting Groundwork and Parenting Strategies methods were supported, particularly the breadth of topics covered in the Groundwork module and the proposed sequencing of relational parenting strategies prior to the use of discipline strategies.

Staff underlined the importance of sensitively broaching the topic of parenting and the effects of parents’ difficulties on their children’s mental health. Suggestions were made about whether to begin initial exploration on parental personality, parent–child relationship, parenting or parents’ own early experiences. Consensus supported the HFP methods and processes designed to constructively tailor the initial exploration of family ecology, including each of these key elements, with the development of a shared understanding of these issues between the parents and the research therapist.

Staff considered that personalisation was difficult to define, likely to be reliant on the individual skills practitioners and, therefore, difficult to reliably assess.

Design

A non-experimental descriptive design was used to conduct a rapid scoping review of relevant clinical and patient safety policy documents relating to care processes and methods for parents affected by personality disorders whose children experience emotional and behavioural difficulties. 74 Limited research resources and better access to documentation meant that the review centred on the SLAM (site 1) policies.

Method

The research team sought to identify current clinical and patient safety policy documents located on the SLAM staff intranet website that referred to personality disorders, child mental health and parental mental health. Eligible documents were searched for relevant text using the following terms: (1) ‘child’ and/or ‘adult’ and/or ‘parent’ and/or ‘family’, and (2) ‘personality disorder’ and/or ‘emotional and behavioural’ and/or ‘mental health’ and/or ‘safeguarding’ and/or ‘child protection’, and (3) ‘care’ and/or ‘assessment, and/or ‘treatment’ and/or ‘referral’, and (4) ‘policy’ and/or ‘guidance’ and/or ‘practice’.

Data extraction and analysis

The SLAM internal website was searched between March 2015 and June 2015. Identified documents were screened for relevance and text was extracted from 34 relevant documents. Thematic content analysis was used to identify key common practice recommendations related to usual care for the target population.

Results

No specific relevant parenting pathways or recommended parenting interventions for the target population were documented in the extracted data. Analysis revealed three key themes relevant to usual-care practices.

Conclusion

Consistent with phase 1 findings, this thematic review revealed no specific parenting pathways and interventions for the target population within the NHS trust concerned. Policy guidance supported an inclusive and co-ordinated approach to the identification, assessment and care of parents with significant mental health difficulties and their children.

Method

The SLAM Clinical Record Interactive Service (CRIS) system (www.maudsleybrc.nihr.ac.uk/facilities/clinical-record-interactive-search-cris/, accessed 31 July 2019) was used to identify and extract relevant anonymised data from the SLAM Patient Journeys System (SLAM PJS) of a cohort (n = 25) of relevant parent service user cases and a cohort (n = 25) of relevant child service user cases.

A CRIS data extraction script was generated using the following terms: ‘personality disorder’, ‘dependant’, ‘child emotional and behavioural problems’, ‘child mental health problems’, ‘family issues’, ‘family problems’, ‘child behaviour’, ‘child problems’, ‘child difficulties’, ‘CAMHS’, ‘child and adolescent mental health service’ and ‘parental mental health’.

Data extraction and analysis

Case note audit data were extracted in September 2015. A researcher (Ruth Wilson), under direction from the chief investigator, used a pre-existing audit tool, Meeting the Needs of Families Affected by Parental Mental Illness (MNFAPMI) (see Appendix 1),142 to benchmark extracted data. The MNFAPMI audit tool was derived from published evidence-based approaches for parents with mental health problems.

Results

The CRIS system identified case notes of 532 adult service users in which child mental health was referenced. Thirty-two case notes referenced both adult personality disorder and child mental health. Of these, 28 case notes met the criteria for parent personality disorder and child receipt of mental health service care. Scrutiny of extracted case note data revealed that none contained documented evidence that the parent service user had received any type of specified evidence-based parenting support.

Further audit of an additional set of 10 case notes, randomly selected from the original cohort of 532 service user case notes, found no other documented evidence of parenting support receipt.

The CRIS system identified 956 CAMHS users where there was documented reference to a childhood emotional and/or behavioural disorder and coexisting parental mental health difficulties. None of these case notes referred to any search terms associated with parental personality disorder. No further action was undertaken to extract information about parenting interventions.

Conclusion

The case note audit provided no further detailed information about the content of parenting support available to service users receiving usual-care practices. The lack of documented parenting support appeared to be at variance with the policy recommendations identified by the thematic review.

It is possible that the results under-reported the support that was available. Data extraction was hampered by the constraints of the SLAM PJS system, where case records are indexed on an individual basis and records of immediate family members are not structurally linked. Furthermore, case note recordings may not have been of sufficient quality and specificity to have extracted relevant enough parenting support information using the specified CRIS search terms or benchmarking by the MNFAPMI audit tool.

While methodologically limited, the findings may have otherwise reflected the underidentification and under-recording of parenting support needs in the target population identified during phase 1. The findings may have also reflected the limited routine use of evidence-based parenting support in usual care.

Identification

Keyworkers in co-operating teams were requested to review their case lists against the study eligibility criteria. 74,141 Keyworkers used the parent identification and referral decision process algorithm, including use of the SAPAS and the SDQ-IS115,118 where necessary, to guide participant identification (see Report Supplementary Material 1). Keyworkers also had access to ongoing liaison and consultation about parent eligibility from the research team.

Consent

After the initial positive identification of a parent who may meet the eligibility criteria, each keyworker determined whether or not it was appropriate for a parent to be approached by the research team. 74,141 A clinically experienced research therapist then offered a face-to-face meeting to discuss the case series and provide a PIS (see www.journalslibrary.nihr.ac.uk/programmes/hta/1219401/#/documentation; accessed July 2019).

Referring keyworkers were also invited to participate in a qualitative interview about their experiences of the research (see www.journalslibrary.nihr.ac.uk/programmes/hta/1219401/#/documentation; accessed July 2019). All participants were fully informed, verbally and in writing, of study procedures. Informed written consent was required from parents prior to full diagnostic screening.

Parents had the opportunity to consider and seek further advice about the implications of participation for themselves and their children prior to consent, with a minimum of 7 days to decide. Research therapists used parent meetings to confirm basic eligibility criteria.

Formal screening and debriefing

The use of gold standard assessment instruments was intended to limit the risk of misdiagnosis. Parental personality disorder was formally assessed by researchers using the SCID-II112 (see Report Supplementary Material 2). All personality disorder types, and combinations thereof, were eligible because the disorders typically co-occur. There is scant evidence that parenting difficulties are more significantly related to any single, specific personality disorder. Child inclusion and exclusion diagnoses were assessed by parent interviews using one of two well-validated, standardised instruments: the DAWBA, for parents of children aged 5–11 years,116 and the PAPA, for parents of children aged 3–4 years. 117 Research therapists were fully trained to use these instruments.

Separate debriefing sessions with parents took place to review and explore the diagnostic assessment outcome (see Report Supplementary Material 2). Debriefing session content and methods were designed with advice from members of the SUAP and from clinicians highly experienced in the assessment and clinical management of people affected by personality disorders.

Participants could withdraw from the study at any time with no consequences for their care. Regardless of eligibility, parents could discuss usual-care options in local adult and child mental health services. Parents received £10 reimbursement in vouchers at each data collection point.

Participant demographics

A specially designed proforma was used to collect descriptive baseline data from parents participating in the case series including parent/child age, sex and ethnicity, family household composition and family socioeconomic status.

Feasibility parameters

Rates of participant identification, consent and eligibility were routinely collected.

Clinical outcomes

The following validated, parent-report measures were completed prior to the intervention starting and after completion of the final session.

Therapeutic alliance

Therapeutic alliance was measured post intervention using the Working Alliance Inventory-Short Revised (WAI-SR) questionnaire. 150

Qualitative interviews

Semistructured topic guides were used for informant interviews. 141 Development was informed by concepts underpinning IPA. Content focused on exploring the subjective meaning and significance of parents’ and keyworkers’ experiences and perspectives on case series recruitment, screening, participation and intervention. Content and probes were developed iteratively by experienced qualitative and service user researchers (CD, LF and TW). Interviews were conducted by a white British female university graduate (Ruth Wilson), aged < 30 years, who had no clinical responsibility for participants and was trained in qualitative interview skills. 151 The researcher used topic guides to build a rapport and to encourage open description of parent and keyworker subjective experiences. 143 All interviews were audio-recorded and transcribed verbatim.

Research therapist requirements

Four research therapists, two from each site, were selected based on their clinical expertise in adult mental health and personality disorders, child mental health and parenting, as well as their experience of delivering manualised interventions.

Three of the research therapists held band 7 NHS posts (occupational therapist/dialectical behaviour therapist, family therapist, family and systemic psychotherapist) and one held a band 8a post (clinical psychologist). All worked part-time on the study.

Research therapist training

Research therapists received eight 3-hour training sessions that included:

• background and context to the research trial and phase 1 findings

• case series recruitment procedures

• SCID-II, DAWBA and PAPA training

• the HFP-M manual, including rationale, aims, format and content

• good practice in working with parents affected by personality disorders

• understanding child emotional and behavioural difficulties

• co-working and lone working processes including the HFP-M joint-working protocol

• working with risk in community settings.

Training was provided by the research therapist supervisor (LH), two expert co-applicants (MM and PM) and a safeguarding lead nurse.

Research therapist supervision

Research therapists received fortnightly group supervision. Each session lasted 2.5 hours, under the direction of an experienced HFP supervisor and the co-developer of the HFP-M (LH). Content focused on case series recruitment procedures, fidelity monitoring and reflective case supervision of the HFP-M implementation. Reflective case supervision reviewed the clinical focus and application of the HFP-M with participating parents, therapeutic progress, management of emergent clinical challenges, therapist safety and the emotional impact of the HFP-M implementation.

Safe and effective care

The well-being and safety of the participating parents and their children were paramount. The following procedures were implemented to support safe and effective provision of the HFP-M.

Ethics review and site permissions

All key case series documents and procedures were reviewed internally by the SUAP, TSC, DMEC and the independent ethics consultant (Richard Ashcroft, Professor of Bioethics, Queen Mary, University of London) prior to external review by the National Research Ethics Service (NRES) Committee London (Camberwell St Giles).

External NRES approval required two full submissions. This delayed the start of the case series recruitment. The major focus of concern for the NRES committee was the potential adverse reactions stemming from the inclusion of parents who had not previously sought a personality disorder diagnosis and the associated participant information.

Ethics approval for the study was obtained from the NRES Committee London (Camberwell St Giles 15/LO/0079). Relevant NHS site research and development approvals were provided.

Feasibility and outcome data

Descriptive statistics were used to describe the feasibility of recruitment, consent, screening procedures and individual case outcomes.

Qualitative data

Verbatim transcripts obtained for analysis were downloaded to NVivo 10 (QSR International, Warrington, UK), a computer package for the management, classification and analysis of text-based data. Parent and keyworker data were initially analysed separately and then triangulated. 141

Data were analysed using the methods of IPA and they were coded at three levels. 143,144 Initially, the researcher (Ruth Wilson) familiarised herself with each transcript, attaching descriptive codes containing initial observations and reflections to data. The researcher then developed second-level descriptive labels which were coded and organised into conceptual categories. Interpretations at this analytic stage intended to capture the subjective value attributed by the participant parents and keyworkers to generated categories. For example, the theme ‘experience of parenthood’ incorporated the subcodes containing emotional responses (e.g. frustration) and parenting behaviours (e.g. seeking support and negative experiences of parenting programmes). Finally, generated results were explored and verified in shared meetings with Crispin Day and Timothy Weaver, who were familiar with data transcripts. The codes, categories and themes generated from the two respondent groups were examined and connections were explored.

Results were subject to validation with a parent and a clinician participant. These procedures verified the generated findings.

Sites and participants

Recruitment to the case series was initially planned to take place over a 6-month period. Ethics approval coincided with school summer holidays, which delayed recruitment because many referred parents did not want to be screened while their child was on holiday. Recruitment and intervention delivery took place from July 2015 to February 2016. Seventeen out of 25 teams (68.0%) referred parents. Modal team referral was one parent (range 1–3).

Twenty-six parents were referred to the case series (site 1, n = 18, 69.2%; site 2, n = 8, 30.8%) as shown in the Consolidated Standards of Reporting Trials (CONSORT) flow diagram in Figure 2. Fourteen (53.9%) parents were referred by adult mental health keyworkers, eight (30.8%) from CAMHS and a further four (15.3%) from parental mental health keyworkers.

FIGURE 2.

Case series recruitment CONSORT flow diagram.

Four of the parents from the referred cohort who met all of the eligibility criteria were offered and accepted to take part in the research intervention. 141 The main reasons for exclusion were evenly distributed: parents who declined participation (n = 5, 19.2%), parents whom researchers were unable to contact (n = 5, 19.2%), parents who did not meet eligibility criteria or were unable to participate owing to acute mental health crises and/or life circumstances (n = 5, 19.2%), and children who did not meet the eligibility criteria (n = 7, 26.9%).

In total, eight of the referred parents were unable to be contacted by researchers or declined participation. Children of three parents were placed on child protection plans during the recruitment and screening process and a further three parents were not able to participate because of acute personal and family crises.

Contact with referred parents

Detailed records of the contact processes between researchers, referring keyworkers and parents were maintained. Researchers contacted referred parents by telephone, text and e-mail, when acceptable. The modal number of completed contacts with parents to agree consent and arrange screening appointments was 6 (range 1–7). The mean duration between referral and agreeing consent was 41.3 days (range 15–76 days). Delays were mainly a result of parent factors, including busy family schedules, school holidays, family health, education appointments, and referrer factors, such as incorrect contact information.

Screening procedures

Researchers contacted 19 parents who gave informed consent to participate in the case series. Further in-depth discussion with these parents about the research project led to the exclusion of nine parents prior to screening for the reasons given in Figure 2.

Ten parents (52.6%) who gave consent for participation completed screening procedures, of whom six were then excluded. Of these, two parents did not meet criteria for the SCID-II research diagnosis of personality disorders, and children of three parents did not meet the DAWBA criteria. Screening was started but not completed for one consenting parent owing to repeated cancelled appointments.

Parents who participated in the screening procedures reported that the screening procedures were lengthy; completion of the SCID-II and the DAWBA generally took two or three 1- to 2-hour appointments.

Measure acceptability and completion

Three parents completed all measures at time 1 (T1) and time 2 (T2). One parent did not complete T2 measures because she could not be contacted. There were no missing data items on any completed questionnaire.

Participant feedback indicated that the measures were acceptable, although lengthy, to complete. Some items needed assistance from the researcher to explain, particularly in questionnaires using American English.

Demographic information

All four case series participants were mothers (Table 1). 141 Index children were aged 3–11 years, three of whom were boys. Participant mothers had no postschool qualifications. Only one mother was in part-time employment. Two mothers were not working by choice. None of the participants had partners who shared parenting responsibilities.

Outcome data

Three out of the four parents completed outcome measures pre and post intervention. Scrutiny of descriptive data showed a pattern of child improvement across the CAMC, the SDQ-Total, the ECBI and the CBCL-Int measures (Table 3). A similar pattern of improvement was shown for parenting behaviour and confidence across the PS and the KPSS measures (Table 4).

Parent 1 reported improvements in the intensity of child behaviour problems and parental child concerns, and consistent improvements in parent functioning. No other noteworthy improvements in child outcomes were reported. Parent 2 reported consistent improvements across all child and parenting measures, with the index child SDQ caseness reported as ‘close to average’. Parent 3 reported a reduction in the level of child behaviour problems and the SDQ score, although caseness remained ‘high’. Parent outcomes at T2 showed little change. Two parents reported reductions in adult distress measured by the SCL-27.

Parent themes

Keyworker themes

Participant identification

The recruitment cohort was small and findings should be treated with caution. Nevertheless, the case series provided evidence of specific service and parent factors that, if more widely held, may hamper recruitment flow.

These included negative parenting intervention expectancies, keyworker topic avoidance and the stigma associated with personality disorders. Interviewed parents described profound despondency about their family circumstances and their parenting role. They also expressed initial scepticism about participation in the HFP-M as a result of previous clinical and parenting support experiences.

Given the recruitment flow and the fact that the majority of referrals did not receive the HFP-M, it is unlikely that referring keyworkers’ exposure to the case series and the positive impact reported by recipient parents would have been sufficient to challenge the negative perspectives described by parents and keyworkers. Despite the development of the Joint Working Protocol, interviewed keyworkers described little subsequent contact with parents during the case series, again reducing the likelihood of learning about potential parent benefit.

Despite engagement events and access to detailed briefing packs, a significant number of referred parents proved to be ineligible prior to screening. Referring keyworkers may have not understood eligibility criteria, were unable to operationalise them accurately, or were keen to refer parents irrespective of their status.

Personality disorder criteria

Generated findings raised questions about the feasibility and acceptability of personality disorder eligibility criteria. Keyworkers, particularly those in child mental health services, found explicit discussion of the diagnostic category difficult with potentially eligible parents. Parents explained that diagnostic status often seemed to be used by clinicians as a generalised explanation of their parenting difficulties and the difficulties of their children. This resulted in parents feeling misunderstood, blamed and acquiescent. Parents expressed concern about the time required to complete the SCID-II and the DAWBA diagnostic screening interviews, which often took two or three appointments.

The research ethics review gave lengthy and detailed consideration to the proposed screening procedures. The research ethics committee (REC) was concerned about the inclusion of parents who did not have an existing personality disorder diagnosis, an objective in the research programme’s commissioning brief. The committee was keen to ensure the clearest possible informed consent procedures for these individuals, including any potentially undesirable consequences in receiving the research diagnosis. Modifications to research information materials to meet research ethics requirements were made in consultation with service user researchers and the SUAP. On review, the SUAP felt that the revised research information materials may have been experienced as daunting and potentially stigmatising by potential participants.

Complex life circumstances

A significant proportion of parents did not complete screening procedures. This was primarily a result of difficulties in contacting referred parents and serious changes in their circumstances. The length of time and the multiple contacts required by researchers to meet the referred parents were substantial. The recruitment and screening process highlighted the complex and fragile life circumstances of the target population. Unrelated to the research procedures, the children of three referred parents were subject to child protection procedures and three other parents were subject to acute mental health and/or life events.

Intervention content

• The HFP-M alliance methods may promote participant engagement and participation.

• The HFP-M Quick Wins may promote confidence, hope and commitment in the context of participants’ complex life circumstances and previous help-seeking experiences.

• Participants may use the combined HFP-M Groundwork and Parenting Strategies modules to implement changes in parenting.

• The HFP-M Firefighting module was validated as a method to help parents manage their life difficulties in the context of the programme’s main aims.

Intervention arm

The HFP-M format and content were the same as summarised in Chapter 4 and Report Supplementary Material 3. 5 This intervention was designed to work collaboratively with parents to:

• explore ways in which severe parental personality difficulties, including personality disorders, have an impact on parenting and child functioning

• identify meaningful and realistic goals for improved parenting and child outcomes

• use evidence-based parenting and parent self-care strategies to improve parenting, child and parent functioning.

The intervention was intended to be delivered over 16 sessions. Each session contained specific manualised content. Six specially trained and supervised trial therapists, two of whom participated in the phase 2 case series, delivered the HFP-M according to a detailed manual. Research therapists were selected, trained and supervised according to the same procedures used in the case series (see Chapter 4). The intervention primarily involved one-to-one sessions with the primary parental caregiver, although other family members were involved when appropriate.

Concomitant interventions

Trial interventions were delivered in conjunction with medical, psychosocial and educational support and treatment services used by participant parents and their families, supported by the HFP-M Joint Working Protocol (see Report Supplementary Material 1).

Participant characteristics

Descriptive data were collected on parent and child age, gender, ethnicity, family household composition, participant diagnostic status and family socioeconomic status. Basic information on keyworkers including professional background and service type was also collected.

Feasibility evaluation

Structured record sheets were used to document key feasibility parameters related to trial procedures and intervention delivery. 5 Relevant fields were completed prospectively by research staff and trial therapists, as appropriate, to obtain the rates of:

• participant identification, including initial approach by keyworker and verbal consent for contact by research staff

• trial participation, including screening, eligibility, informed written consent, randomisation and reasons for non-participation

• data collection at baseline and at follow-up, including reasons for missing data

• intervention use, including uptake, session attendance, retention and reasons for missed sessions and dropout.

Clinical evaluation

Validated parent-report measures with well-established psychometric properties were used to assess clinical acceptability and health-economic outcomes. 5 These measures had been previously reviewed by service user representatives to ensure relevance, comparative ease of use and that they had been tested in the phase 2 case series. Outcomes were to be measured at three time points: T1, pre-randomisation baseline; T2, post-intervention follow-up, approximately 4 months from baseline; and T3, 6-month follow-up, approximately 10 months from baseline. Measures were collected by researchers who were blind to the group allocation.

Clinical outcome measures

Intervention acceptability: parent-research therapist alliance measure

Therapeutic alliance was measured at T2 using the WAI-SR. 5,150

Economic evaluation measures

The economic evaluation was conducted from the UK NHS/Personal Social Services (PSS) perspective and societal perspectives. Intervention costs were estimated by combining data on the number of screening and intervention sessions provided with the unit costs derived from local data on service expenditure and activity. Costs included therapist time, on-costs, overheads and capital. Estimates of staff training and supervision costs were also included. 5

Resource use and economic outcome information for parents and children was intended to be collected at each assessment point using the Client Service Receipt Inventory (CSRI) and EuroQol-5 Dimensions (EQ-5D)5.

Parent qualitative data

Qualitative interviews were conducted with parent participants following the T2 follow-up assessment. 5

Interview content, data collection and analytical methods were grounded in IPA. 143,144 The use of IPA was intended to focus on parents’ subjective, lived experience of, and reactions to, participation in the trial’s research methods and interventions rather than parents’ broader perspectives.

Interviews were conducted using a semistructured topic guide (see Appendix 4). These were employed flexibly and were subject to iterative development in order to reflect and explore generated themes in subsequent interviews. The guide used an open-ended approach that enabled interviewers to explore designated topics and respond flexibly to the conversational leads of interviewees as experts of their own experience. Research interviewers aimed to develop a comfortable space in which participants felt free to talk openly and honestly about their experiences.

All participants who completed T2 data collection (n = 32) were invited to interviews. Twenty-seven participants consented and five declined, owing to fatigue following completion of questionnaires or concerns about audio-recording. Fourteen participants had received the HFP-M and 13 participants had received usual care. Demographic information about qualitative interviewees is provided in Appendix 5.

Twenty-six interviews were conducted in participants’ homes. One was conducted in a café that offered sufficient privacy. Four interviews were conducted with a significant other present. A total of 26 out of 27 interviews were audio-recorded. One participant did not want to be recorded but dictated data to the interviewer.

Keyworker qualitative data

Keyworkers were selected based on their involvement in recruitment and case management of parent participants. Interview content, data collection and analytical methods were grounded in Thematic Content Analysis. 157 The purpose was to obtain a broad understanding of the professional and service factors affecting keyworkers’ involvement in trial procedures and their perspectives on interventions provided.

A semistructured topic guide (see Appendix 6) used an open-ended, exploratory approach that was designed to explore specific topics of interest. Interviewers responded flexibly to the responses and content provided by interviewees. Interviews were conducted by telephone and audio-recorded.

Of the 27 referring keyworkers who were selected, 12 consented and completed the interview. Those not taking part in the interviews were on maternity leave, no longer employed or not responsive to the interview invitation.

Settings

Recruitment took place in sites 1 and 2 mental health services as well as concomitant local authority children’s social care services (see Chapter 2). 5

Identification

Keyworkers were encouraged to use their professional judgement in undertaking an exploratory discussion about the research with potentially eligible participants. 5 Keyworkers were advised to carefully consider the participation risks and benefits for both parents and their families. Parents were provided with verbal and written information about the trial by keyworkers. Following discussion, keyworkers determined whether or not a parent was agreeable to being contacted by a researcher.

Keyworkers provided the research team with telephone contact details for potential participants who had provided initial verbal consent. 5 The referring keyworker was informed if contact could not be made. When contact was successful, more detailed information about the study aims, eligibility criteria and procedures was given verbally by researchers to referred parents. Parents also received a PIS by post and/or e-mail, according to their preference (see www.journalslibrary.nihr.ac.uk/programmes/hta/1219401/#/documentation; accessed July 2019). Parents were encouraged to discuss the PIS with family members, keyworkers and other professionals in their network, as appropriate.

Parents were contacted again by their preferred means of communication 1 week after anticipated receipt of the PIS. When contact was successful, a researcher sought to answer any further parent questions about the research. The potential risks and benefits of being involved in the study were discussed, along with confidentiality issues, randomisation procedures and the right to withdraw from the study at any stage. During this conversation, the researcher established whether the parent (1) was willing and able to participate, (2) was unwilling/unable to participate or (3) required additional time/information to decide.

Consent

Following parent agreement, researchers arranged a face-to-face meeting with each referred parent at a convenient time and location to obtain informed written consent. This meeting reviewed the PIS as well as parents’ understanding of the research, and addressed any outstanding questions and concerns. When the parent was agreeable, the researcher obtained two signed copies of the consent forms, one of which was held by the research team and one was retained by the participant.

Allocation and randomisation

Participants were allocated a unique, anonymised identification (ID) number by the trial co-ordinator. Details were entered into the Independent Randomisation Service, an independently monitored computer system of allocation managed by the accredited Clinical Trials Unit at King’s College, London. 5 Trial participants were randomised in equal numbers to one of the two trial arms between 11 May 2016 and 29 March 2017.

Allocation outcome for each participant was communicated confidentially to the feasibility trial senior clinical supervisor (LH), who arranged for either an intervention arm HFP-M therapist or a usual-care arm Being a Parent facilitator to contact the allocated participant as appropriate. Other members of the research team including the chief investigator, statistician and research workers remained blind to participant allocation status.

Intervention delivery in both arms of the trial was planned to begin as soon as possible after allocation.

Screening and time 1 assessments

Following receipt of parent consent, researchers arranged to administer two brief parent-report screening measures at a convenient time and location. 5 Participants received telephone and text message reminders about screening and initial baseline assessment. A reminder text message was sent 24 hours before scheduled meetings.

When both the parent and the index child were eligible, researchers established whether or not sufficient time was available to complete baseline measures. When required, a separate meeting was arranged. The T1 measures were administered in a standard sequence and took approximately 60–90 minutes to complete. Researchers helped to clarify questionnaire content and instructions when necessary. Any signs of parent discomfort were addressed sensitively and supportively. Participants were reimbursed £10 in vouchers per hour for the time involved in data completion.

Time 2 and time 3 follow-up assessments

Researchers maintained periodic contact with participants, updating them on research progress and reminding them about arrangements for completion of T2 and T3 assessments. Each participant received a telephone call from a researcher at least 1 week prior to data collection, the purpose of which was to verify the participant’s latest contact details and to review availability for the remaining research procedures. Persistent and non-intrusive efforts were made to reach each parent by telephone to arrange data collection at each time point.

Researchers remained blind to the randomisation allocation during outcome measure completion. Participants were requested not to reveal their allocation status until the point at which process evaluation interviews were conducted. The randomisation status of participants was stated in a sealed envelope, opened by researchers after they conducted the T2 follow-up outcome assessment and before conducting the qualitative interview.

Interview with keyworkers

Parent participants were informed verbally, and in the trial PIS, that the researchers may conduct a separate interview with their keyworker. 5 Keyworkers received their own PIS and Consent Form prior to taking part in a qualitative interview (see www.journalslibrary.nihr.ac.uk/programmes/hta/1219401/#/documentation; accessed July 2019). Interviews were conducted by an unblinded researcher. Keyworkers were not reimbursed for their participation.

Data management

Identifiable data, such as participant names and addresses, were removed from completed research measures. An anonymous ID was assigned to each participant to identify the questionnaires and demographic information. Personal data including participant names and contact details were transferred only electronically using encrypted USB (universal serial bus) drives and secure NHS e-mail servers.

Qualitative interviews were recorded on encrypted devices as per the requirement of the sponsor. Completed recordings were uploaded onto password-protected computers and deleted from recording devices once transcribed. Recordings were uploaded and transcribed as soon as possible after interviews were completed. Participant numbers were assigned to each interview transcript and anonymised text was used in data transcripts for names, places or any other identifiable information.

The chief investigator acted as custodian of the data in accordance with the UK Data Protection Act162 and the terms of the sponsor and funder. Personal contact details of participants were retained for the duration of the trial to enable follow-up. Other research data generated by the study will be retained for 7 years to cover contractual liability.

Statistical methods

The statistical analysis was mainly descriptive. 5 It aimed to provide estimates of key trial parameters and to inform power calculations for a future definitive trial. A description of the sample was presented using means and standard deviations for continuous data, or medians and ranges where data were skewed. Frequencies and proportions were used to analyse categorical variables. Feasibility of trial retention was assessed using the proportion of a predetermined parameter and estimated 95% CIs. Because of the small number of follow-ups at T3, the original analysis plan to use multilevel models to estimate the likely range of intervention effects was revised to use analysis of covariance (ANCOVA) models with pre-randomisation values as a covariate. 163 Standardised ESs were calculated by dividing the estimated treatment effect by the standard deviation at baseline (Cohen’s d). Population variances for future power calculations were determined using the upper 80th percentile of CIs around the estimated population variance, as recommended by Browne. 164

Economic evaluation

Non-intervention service use and cost comparisons were made between the two groups at each of the follow-up time points (T2 and T3). As baseline CSRI data were not collected, the analysis could not control for baseline costs. Costs over the time points were then combined with the intervention costs and again compared between the two groups. As cost data are skewed, the analysis used bootstrapped regression models to generate 95% CIs around the differences in costs between the two groups. A cost–utility analysis was subsequently conducted by linking the cost data with QALYs. QALY gains were calculated using area under the curve methods with linear interpolation between scores, controlling for baseline utility. 165 The time intervals between the time points varied among the participants. The analysis used the time intervals that were specific to each participant. The point estimates of cost and QALYs were used to indicate whether the HFP-M was dominant, resulting in better outcomes at a lower cost, or whether each extra QALY produced by HFP-M, or usual care, was at an increased cost.

Dominance was achieved by a group if the costs were lower and the outcomes were also greater when compared with the other group. If both costs and outcomes were higher than the other group, then the incremental cost-effectiveness ratio (ICER) was calculated in order to identify the extra cost incurred per extra QALY. The ICER was produced by calculating the difference in cost between the two groups, divided by the difference in their QALYs. As the economic analysis was based over a short time period, discounting was not applied to costs and outcomes.

The non-parametric bootstrapping method was used to produce cost-effectiveness planes using 1000 cost–QALY combinations to illustrate the uncertainty surrounding the results using bootstrap regression models. This allowed the research team to determine the probability that the intervention resulted in:

1. lower costs and more QALYs

2. lower costs and fewer QALYs

3. increased costs and fewer QALYs or

4. increased costs and more QALYs than usual care.

This feasibility trial was intended to generate indicative cost-effectiveness estimates within but not beyond the study period.

Parent qualitative data analysis

Qualitative data transcripts were transcribed verbatim and downloaded to NVivo 10, a computer program that manages, classifies and analyses text-based data.

Using methods consistent with IPA,143,144 an iterative data-driven approach to analysis was used to explore and analyse parents’ subjective experiences. 5 Analysis began during data collection and progressed through a series of systematised and non-linear stages. The primary qualitative researcher (Liberty Mosse) familiarised herself with each transcript by reading each transcript thoroughly and recording initial observations and reflections. Liberty Mosse then systematically re-read transcripts, attached descriptive labels to small segments of text and then grouped similar labels together to form promising data nodes. Liberty Mosse then organised promising nodes derived from the first 11 data transcripts into a preliminary coding frame of generated themes and subthemes.

Verification of this preliminary coding frame was undertaken by a servicer user researcher (LF) who reviewed the frame, relevant transcripts and derived nodes. Liberty Mosse and Lisa Foote then reconciled their preliminary interpretations of the data available.

Remaining transcripts were uploaded to NVivo 10 as they became available. New data were analysed according to the verified coding frame. As additional analysis was undertaken, new nodes and themes were produced and the verified coding frame updated. This process was supervised by Crispin Day. Topic guide content and interviews were modified in the light of generated findings.

Final analysis was conducted by the primary qualitative researcher who coded all remaining transcripts. The resulting analysis was explored and verified by experienced qualitative researchers (CD, TW, LF). Saturation was monitored throughout data collection by examining the rate and frequency at which novel codes and themes were generated.

Interviewee characteristics are provided in Appendix 5.

Validation was undertaken by Liberty Mosse, Crispin Day and Lisa Foote with interview participants. 151

Five interviewees were invited to a group discussion of findings, three of whom attended. At the event, Liberty Mosse and Lisa Foote presented findings, using anonymised extracts to ground results in specific data, for discussion in an open and exploratory way and invited participants to reflect on the authenticity and representation of the findings (see Report Supplementary Material 5). Participants validated the structure of generated findings. Some specific themes and subthemes were renamed to improve clarity and more accurately reflect participant experience.

Keyworker qualitative data analysis

Interviews were transcribed verbatim, uploaded to NVivo 10 and analysed using thematic content analysis. 5 Thematic content analysis was undertaken in a series of iterative steps. 166

First, each transcript was read thoroughly by the primary researcher (Liberty Mosse), who generated an initial list of observations, reflections, ideas and meanings from which a provisional framework for understanding the data was developed. Based on this provisional framework Liberty Mosse re-read transcripts, attaching descriptive labels to small segments of text and creating preliminary categories in order to understand and further analyse the data. A second researcher (Nadine Kendall) re-read selected transcripts, noting observations and reflections in relation to the provisional framework and generated findings. These researchers shared their findings in order to produce a unified set of generated categories based on salient and prominent features of the data. These generated categories were shared with Crispin Day in order to establish a coherent set of themes and subthemes to describe the data.

Interviewee characteristics are described in Appendix 7.

Synthesis of findings

Findings from each of the quantitative and qualitative analyses above were combined in order to report on the principal aims of the feasibility trial.

The relevant themes and subthemes derived from each qualitative analysis, together with illustrative data quotes, are reported in relation to the feasibility, acceptability, clinical outcome and cost aims of the trial in subsequent chapters.

Interpretative phenomenological analysis of parent interview data generated three main themes, each with a number of subthemes. The overall structure of the parent qualitative results is described in Appendix 8. The main themes are listed here with the relevant trial aim in brackets:

• theme 1 – experience of RCT methods and procedures (trial feasibility)

• theme 2 – life circumstances, personal histories and help-seeking (trial feasibility)

• theme 3 – experiencing a psychoeducational parenting intervention (intervention acceptability and clinical outcome).

Thematic content analysis of keyworker interview data generated four themes, each with a number of subthemes. The overall structure of the keyworker qualitative results is described in Appendix 9. The main themes are listed here with the relevant trial aim in brackets:

• theme 1 – engaging teams and keyworkers (trial feasibility)

• theme 2 – implementing trial methods and procedures (trial feasibility)

• theme 3 – keyworker decision-making (trial feasibility)

• theme 4 – intervention characteristics (intervention acceptability and clinical outcome).

Independent ethics review and site permissions

Ethics approval was obtained from Health Research Authority South East Coast and Brighton & Sussex Research Ethics Committee (reference: 16/LO/0199). Relevant NHS site research and development approvals were provided.

Safe and effective care

The well-being and safety of participating parents and their children were paramount. The HFP-M augmented usual care. In line with the HFP-M Joint Working Protocol, primary case management responsibility remained with the referring keyworker. As described previously, the Joint Working Protocol set out the agreed roles and responsibilities, clinical working practices and co-ordination between the HFP-M research therapists and routine service practitioners.

Potential adverse events

The chief investigator was responsible for reporting to the DMEC and to the responsible REC committee any serious adverse event that was both related to the research procedures and unexpected. Researchers carrying out interviews and assessments with participants were instructed to report any adverse circumstances to the project manager and principal investigator, no matter how minor the circumstances may appear. Therapists were required to impart information on potentially serious adverse events to their supervisor during supervision sessions and to the chief investigator at other times, if necessary. A standard form for reporting serious adverse events was used by all trial staff. No serious adverse events were reported during the study.

Access to databases

The chief investigator (CD) acted as custodian of the data in accordance with legislation and the requirements of the research sponsor (King’s College London) and the funder (NIHR, UK).

Subtheme 1: trial procedures

This subtheme reflected participants’ practical experience of completing the methodological procedures required for participation in the feasibility trial. Participants offered limited, but generally positive, descriptions about the information they received from keyworkers and research staff about the aims and purpose of the research:

They fully explained the whole scenario to us, so we were very aware about what was going on.

Participant 1002, paragraph 26

Views on screening and outcome questionnaire completion varied among participants. Some parents felt that questionnaire completion was useful and hoped that it provided awareness of their difficulties:

I think by us doing that questionnaire, it would kind of give you guys an insight into what kind of support [I need].

Participant 1020, paragraph 4

Other parents were more cautious about their experience of questionnaire completion, highlighting the emotional impact of answering questions about significant personal and family difficulties:

Answering those questions can have a mental impact. Can make you feel guilty or like a bad parent. When ringing to make appointments warn people that they are quite in-depth.

Participant 2011, paragraph 5

Generally, participants were complimentary about the manner, sensitivity and understanding of the researchers who conducted data collection:

Meeting [the researchers], it was really lovely . . . and very respectful and considerate of how I’m feeling and, [they] were able to recognise that if I’m upset and I need to stop . . . which I think is really, really important.

Participant 2008, paragraph 13

Subtheme 2: trial design choice

The most significant methodological design issue for participants was the use of randomisation. Some parents, usually those randomised to the intervention arm, described how they fully accepted the process of random allocation:

. . . there’s potentially this really useful programme . . . but no, I always knew there was a chance I would be in the other group . . .

Participant 1013, paragraph 45

Despite understanding the logic of the purpose and the procedures used in the trial, some parents felt that randomisation was not an appropriate procedure mainly because it presented a risk to receiving the HFP-M:

I don’t know . . . you’re doing these questionnaires and . . . you’re being truthful about it, and you’re asking for help. I don’t think it should be a computer that’s deciding whether this child or this adult needs help.

Participant 1034, paragraph 54

Parents also expressed reservations and doubts about random allocation because of the significant needs of the families involved in the trial:

I think that’s completely wrong. Because what happens if there’s a family out there who’s really struggling? And then there’s a family that’s not. And you’ve given the 16 hours to the family that’s not really struggling and you’ve given that one session to that poor family that is struggling.

Participant 2003, paragraph 85

Er, to be honest I’m not too sure, it’s kind of annoying because often maybe some of those parents that got overlooked who need the support so in that sense I’m not a terribly big fan of it.

Participant 1030, paragraph 46

Other parents, most frequently those allocated to the intervention arm, felt that, while regrettable, randomisation was necessary for service development and the advancement of research:

I don’t know, I think it’s like trial research of anything really, you’ve got to have two sides of the story . . . to know the difference of help or if you don’t get the help, I suppose I was pleased that we was one of the ones that did get it so . . . I did understand it.

Participant 1016, paragraph 13

But, I also understood that it’s research and that, that in order to do research properly you have to have um, it’s split like that, you have to have one, you know, one group doing it the same and one group doing it differently.

Participant 2008, paragraph 22

Subtheme 3: lived experience of trial allocation

Subtheme 3 focused on the emotional impact of trial allocation. For some parents, concerns about allocation began at the point at which the randomised design was explained:

When, when [the researcher] said, ‘It could be a one session or a 16 session. It depends’, I was worrying then.

Participant 1024, paragraph 58

Participants’ emotional response to the randomisation decision was broadly determined by participants’ resulting allocation. Most participants allocated to the intervention condition described a sense of relief and happiness:

Oh gosh I was elated.

Participant 1020, paragraph 21

Luckily I got the longer term, so yeah that made me quite happy.

Participant 1018, paragraph 19

Some participants, relieved to have been allocated to the HFP-M, also described the potential distress they may have felt had they been randomised to the usual-care condition:

There’s an opportunity here but, well, it might not be yours. It would have really . . . made me very low, actually . . . it would have had a very negative effect on me.

Participant 1023, paragraph 25

Some parents felt a sense of resignation about allocation to the usual-care condition, which resonated with an established pattern of disappointments in their lives:

To be honest with you, I’m very negative anyway about myself and when they were going through the questionnaires and told me that I was qualified and I would either get the one session or the 16. The first thing that came into my head was, ‘I know I’m going to get the one session’ so because . . . I’m so negative on how I think anyway, so I wasn’t really that disappointed because I always expect the worst I guess.

Participant 1015, paragraph 2

I’m trying to sort myself out and everything. What’s the point? You try but you don’t get nowhere . . . That’s alright, no one’s fault is it. It’s just life, I should have known.

Participant 1029, paragraph 69

Some parents found it difficult to understand why they had not been allocated to the trial intervention given the nature of their needs:

I was told that there was a chance that I might not be accepted onto the programme . . . I filled out all the questionnaires . . . and my score was really high . . . when I got contacted back and they said that . . . I hadn’t been accepted and I said ‘Why, because my score was really high?’

Participant 1034, paragraph 18

A significant number of parents offered detailed and emotional accounts of their disappointment and anger following allocation to usual care. For some, this resulted in a sense of alienation and withdrawal:

When I didn’t get them and I was proper disappointed and angry so I didn’t even answer the phone or reply to the e-mails . . . because I was just angry and **** off and I knew, like, one session just wouldn’t do it and because . . . in my head I got 16 sessions when I didn’t get them it . . . was upsetting because I put all my hopes on these 16 sessions fixing me.

Participant 1029, paragraph 48

Other parents carried a sense of recrimination and self-blame about the outcome of trial allocation:

Also, it should be done by the needs of the child and the parent, not random. As a mum, I personally didn’t believe that I was good enough, or my son was, to get the sessions. I thought, ‘for real, I opened up and I felt I was stressed out and my head was messed up and then no one helped’ . . . I thought they thought my problems were too much.

Participant 2011, paragraph 7

Subtheme 1: clear, personal communication

Referring keyworkers usually heard about the trial either from team colleagues, most often during team meeting case discussions, or directly from researchers, during presentation visits to their team:

It was probably through the [service manager] and then I think actually [researchers] might have come to our team meeting.

Keyworker 4006, paragraph 21

Keyworkers preferred direct contact with researchers to being sent more generalised e-mail information. Face-to-face discussion allowed keyworkers to clarify and feel assured about the relevance of the research trial, its purpose and methods:

It was presented in a quite detailed way and we had opportunities personally to discuss concerns, it was quite helpful . . . Sometimes when you get information through an e-mail and it’s not the same as having people coming in to really tailor it around us, so that helped.

Keyworker 4007, paragraph 41

Although keyworkers mainly considered the trial information provided adequate for identification and referral, some keyworkers wanted better plain English summaries and more guidance about how to explain the trial interventions to parents:

I didn’t feel like I had a lot of information about the programme itself . . . I got, the gist of it . . . a mixture between a parenting programme and something that’s more therapeutic . . .

Keyworker 4002, paragraph 41

I don’t know it well enough to be able to explain it to someone. So, I think kind of guidance on that may be helpful, just how to kind of explain it in a way that doesn’t just sound . . . clinical. I think that maybe can be off-putting for people. I didn’t get that guidance.

Keyworker 4015, paragraph 35

Subtheme 2: proactive, persistent contact

Keyworkers found that frequent reminders and proactive contact from the research team helped them to keep the trial in mind, especially given the demanding context of their routine clinical work:

You have to continually promote these things for people because you know they’re very busy out and about in the community and at home visits and sometimes it’s just continually reminding people what’s out there for people.

Keyworker 4006, paragraph 63

Regular updates on the referral progress from the research team were useful, as was, although less commonly organised, a nominated link practitioner in the clinical team designated to liaise with the research team.

Subtheme 1: trial criteria

Trial criteria helped the majority of keyworkers to identify parents who they thought would be suitable for the trial. Some keyworkers were disappointed that inclusion and exclusion criteria restricted access to the trial for parents whom they were concerned about and considered could benefit.

Keyworkers described giving careful consideration of multiple family mental health and other needs and their match with trial criteria:

She was struggling and it was clearly linked to the struggles within the family. A lady who was a single parent and who had many children and more than one of them displayed some difficulties, like emotional difficulties and behavioural difficulties. She seemed to have met the criteria for your research project and also, she seemed to be in need for support.

Keyworker 4014, paragraph 7

Keyworkers were not only matching parents with trial criteria, but also giving attention to parents’ capacity to engage and benefit from the trial. Some keyworkers described some referred parents’ relief that they did not meet trial criteria on screening:

. . . you know the other thing is, what is that patient’s capacity to actually benefit from and utilise what you offer?

Keyworker 4003, paragraph 37

Subtheme 2: randomisation

Keyworkers were sometimes initially wary about the consequences for service users of a trial involving randomised allocation. Keyworkers gave serious consideration to the possible negative effects of random allocation on parents and the potential consequences for the keyworker:

So, I asked lots of questions about it, at the time, because I just thought, this is really, potentially setting people up to feel distressed which, if they’re allocated into the control group, will be something that potentially care co-ordinators will have to try and work with the possible distress that that could throw up.

Keyworker 4016, paragraph 13

Half of the keyworkers expressed misgivings about the use of random allocation in the trial design. This was frequently based on their view that randomisation represented the restriction of an intervention that should, in their view, be more widely available:

It just feels such a shame, I think that’s the difficulty, that there is a treatment that’s been so optimal, that the . . . family might not get to have a trial of it.

Keyworker 4010, paragraph 68

At the same time, some keyworkers were pragmatic about randomisation, often seeing the trial as a means of offering an intervention that would otherwise not be available to all:

They just wanted some parenting support, so I don’t think they really minded the fact that it was a 50/50. No one complained about it, no one said that there was an issue.

Keyworker 4002, paragraph 59

Keyworkers described processes that helped them to discuss the trial with parents, including adopting an open and straightforward approach with parents about the trial design and the potential outcome of randomisation:

Well randomisation is always a bit fussy isn’t it, and I think, just being very clear about, you know, numbers and what might happen and what might not happen enabled me to be very clear with the person I referred, so that I could try and get her as ready as possible for, possible disappointment . . .

Keyworker 4016, paragraph 89

Keyworkers were also aware of the emotional effects that random allocation had on themselves and acknowledged that these may be different from the reactions of parents:

This family completely understood the notion of it and were very on board with understanding that they may or may not get [Helping Families Programme]. I think it was probably more concerning for me than it was for them.

Keyworker 4010, paragraph 70

These effects were moderated for some keyworkers by knowing that the usual-care condition included the single psychoeducational session:

What made it easier when she was refused the other intervention [Helping Families Programme], she was still offered something. At least she was offered something.

Keyworker 4014, paragraph 47

Subtheme 3: referral pathway and progress

Keyworkers mainly construed referral to the trial as the opportunity to seek an additional service for parents who may otherwise not be available, rather than the opportunity to participate in a research programme:

I don’t know whether all services are as good as this one, but we just seemed to . . . you all got back to me quickly.

Keyworker 4017, paragraph 85

Keyworkers largely found the trial referral pathway straightforward and responsive:

I found a pathway to yourselves very easy and smooth and accommodating of us.

Keyworker 4003, paragraph 23

They appreciated the rapid response of the research team to keyworker enquiries, which they felt helped to engage referred parents:

It was a very straightforward system and it was quick. Where you have systems that are just straightforward and not too complicated, you’re gonna get better results.

Keyworker 4002, paragraph 113

Keyworkers frequently felt well informed as parents progressed through the trial procedures and found research team feedback helpful:

Communication [was] very, very good. I received the e-mail back informing me what happened to the client, what she was offered, where she was allocated. It was very helpful.

Keyworker 4014, paragraph 43

Compatibility of parent concerns with trial aims content

Participants’ primary, secondary and tertiary concerns about their child, derived from CAMC data, were categorised to examine their compatibility with the aims and content of the trial aims (Table 13).

The concerns identified by parents were highly compatible with the aims and content of the trial. The most common concerns were related to children’s conduct and oppositional behaviour (n = 69, 50.0%) (see Table 13). Other common concerns were related to parent–child communication, child self-regulation and emotional distress.

Subtheme 1: life circumstances and personal histories

Participants often emphasised the deep connection between their experience of parenting and their own mental health difficulties:

At the time, the depression was quite hard on me . . . I was at a point where I was actually slitting my wrists. I wanted to die and I was going through it myself. I didn’t see a point in living, so it was very hard for me to parent [my child] as well as keep myself at a certain point.

Participant 1003, paragraph 20

Parenting was affected not only by parents’ mental health difficulties but also by their wider stressful circumstances:

Because at that time, with the difficulties of everything that had happened . . . my parenting skills was proving quite difficult and I was finding it extremely difficult to maybe bond and communicate and understand what was going on with the kids because I also had a lot of personal issues going on as well. Then on top of that, there was issues that were out of all our hands that were also going on for me and the kids.

Participant 2010, paragraph 127

Stress was often cumulative across a range of areas in parents’ lives, including child and family health difficulties and disability as well as social isolation and economic disadvantage:

. . . it’s just been so hard and everyone always just sees me as the person, like my birth mum’s got learning difficulties, my brother’s got learning difficulties, X [partner] has got a drinking problem, my dad’s old he’s got his drinking problem plus his wife just left him. So . . . you just have a lot and then it just like, I just feel very overwhelmed and then it’s yeah, I just feel like I’m trying to stay afloat but then I’m kind of sinking then also with having my own medical conditions.

Participant 1021, paragraph 88

My children weren’t going to school, I’d lost two children that had passed away, I was going through a bad time, I’m living in housing [that] wasn’t very good.

Participant 1036, paragraph 125

Participants also described personal histories characterised by persistent adverse childhood and adult life events, such as intimate partner violence, family instability, lack of parental involvement and neglect:

. . . a lot of things I didn’t realise had kind of like happened in my childhood not like bad things but I was practically like as a teenager left to raise myself. So, homework wasn’t checked, I put myself into college and from there I basically done my own thing. I think the problem is more with me as a parent than with my child being a child . . . ’cause I don’t feel like I was ever equipped with parenting skills.

Participant 1021, paragraph 11

I’m explaining to them look, I was abused, I’ve got issues, I need the help.

Participant 1019, paragraph 74

Stressful life circumstances and past experiences provided the foundation through which many parents made sense of their own parenting, their children’s developmental needs and contact with professionals:

[My] family have been through quite a traumatic life so far . . . I was . . . brought up by my mum so I never had any father figure. It’s always been winging it.

Participant 1002, paragraph 4

Especially if people have been like in situations like me, like domestic violence. You get a lot of mums that are on their own . . . the father’s hit the mother and it’s always the children that are going to suffer. The mother suffers . . . and I think you know children’s behaviour will change, my children’s behaviour changed because they seen me going through it.

Participant 1036, paragraph 127

I guess it’s sort of difficult because most of my mental health problems come from being badly parented, like 90% . . . that’s been my big problem. That’s why . . . I avoided having a child . . . for 20 years. Even though I desperately wanted to have a child and a partner and a happy family, I just kept choosing really inappropriate partners and, but I knew I would never have children with them because I was scared I was going to turn into my mum.

Participant 1023, paragraph 13

Subtheme 2: help-seeking

In the main, participants highlighted previous negative experiences with mental health, social care and other support services:

I remember, at one point, I was getting counselling from the family justice centre and the lady was really, really judgemental.

Participant 1020, paragraph 104

For some participants, these help-seeking experiences appeared to evoke and reinforce more deeply held beliefs about the difficult and unfair nature of their circumstances and personal histories:

The group here is absolute **** . . . they don’t want to do any referrals . . . so they stay employed . . . so, they refuse to refer me to the [specialist mental health service] . . . that deals specifically with my issues, they refused, they don’t want to refer me or to do anything more . . . I’ve lived a life-long of being angry, it’s just accepting there’s nothing one can do about it, that’s it.

Participant 1019, paragraph 82

Some parents had previously participated in psychoeducational parenting groups. Positive experiences often encouraged their further involvement in the research trial:

I was up for it, ‘cause I’d done two parenting courses . . . and I really enjoyed it . . . so, when I got told that someone would come here and we’d get some sort of help . . . I thought it would be good to sort of get up-to-date advice sort of what to do.

Participant 2003, paragraph 14

Some parents enthusiastically welcomed participation in the research intervention trial:

At the time . . . I really wanted the help actually, so I was actually really hoping I would be in the parenting group [HFP-M intervention] . . . because I was going through a lot, like with mental health and depression and I wanted some support because also my son had some anxieties as well, at the time, so I just wanted . . . to get some help around that and how to be able to work with him and his behaviours also alongside my issues as well. So yeah, I was really up for it, like I wanted, yeah.

Participant 1001, paragraph 2

For other participants, their unrewarding and sometimes futile experiences at home and with services provided motivation to seek out the new support available through the research trial:

I was just hoping that, maybe, like, even though I’m quite a strong person myself, where my [son] is concerned, well, I just wanted some help really. I’m just banging my head against a brick wall.

Participant 1034, paragraph 21

However, for other participants their hopes were tempered by caution and pessimism, often because of previous negative life and service experiences:

That something; you get to the point where you go through all these things and you’ve got that hope but you feel so sort of, like, do you know what, it’s not going to happen, I mean, but you know, deep down inside that there is a possibility of that hope, so you just push through.

Participant 1015, paragraph 26

You start believing that things aren’t going to be any different, and even if it is going make that effect or difference, you just sit there, and the way you view things, and how you think that all these things are, when they’re offered to you, it’s like, same old, same old . . .

Participant 1015, paragraph 9

Parents described a range of different hopes related to participation in the trial intervention. These included improved relationships with their children, new parenting skills (e.g. better understanding of their children’s emotional needs and more consistent family boundaries), as well as changes in children’s behaviour and emotional well-being, such as reduced aggression and lower anxiety:

The way that I parent, the way that she gets angry, the way I react to her, the way I can’t do boundaries and I’m not consistent, the way I don’t have rules, the way there’s no discipline, she talks to me like rubbish, she hits me and things like that . . .

Participant 1029, paragraph 28

To kind of cope more as a parent and not feel so negative towards my child and helping with the behaviour rather than just kind of generalising everything. So, I know I needed help because the feelings I had at the time was strong. I wouldn’t say hate but a strong dislike and I felt sad because she’s my child and no parent should feel like that. So, I was quite happy that I was going to get some help and in turn that helped me.

Participant 1030, paragraph 38

Because I wanted to improve my parenting skills and my confidence, and I was worrying about my son and I, especially . . . worry about the impact of my own illness on my children. So, I was interested to see how I could improve relationships between me and my children. And how to parent them better.

Participant 2008, paragraph 33

Subtheme 1: sensitive, careful deliberation

Some keyworkers highlighted the importance of individualised decision-making based on sensitive consideration of individual service user needs, the potential impact of trial participation and the potential consequences for the keyworkers themselves:

So, you can reactivate . . . that sense of feeling that they’re not good enough or judgement. And then you’re going to activate what we could call a defensive reaction and often aggression and hostility.

Keyworker 4003, paragraph 37

This subtheme reflected keyworkers’ wider consideration of parents’ life circumstances and adverse experiences prior to broaching trial participation with parents. At times, this elicited a protective response from some keyworkers:

People who perhaps have some issues, perhaps are clearly less well off than other people already or have issues of not being entitled to good things. You might think twice in case they didn’t get accepted they might perceive it and feel it as a rejection.

Keyworker 4007, paragraph 37

Subtheme 2: pragmatic, opportunistic referral

Keyworkers also described a more pragmatic and opportunistic decision-making approach that sought to make the most use of the scarce therapeutic resource available through the trial:

Sometimes with research projects, people get a service they wouldn’t normally get. So, if you think it’s going to benefit who you’re referring, then that’s a positive thing by potentially getting an intervention they wouldn’t have got.

Keyworker 4006, paragraph 35

This approach mainly focused on access to the interventions available rather than the research processes:

I kind of feel, it was better than not having anything at all. All those families who went on the programme benefited and they wouldn’t have got that from anywhere else. At that point in time, we didn’t have anything else.

Keyworker 4002, paragraph 49

It often involved taking a broad caseload approach to identification and referral, examining family needs and identifying who might benefit from the interventions available:

You’re like, right, okay. What’s going on with these families? They’re vulnerable. What are the issues? How do we make a difference? And I’m literally grouping them together and identifying all those who would benefit from parenting alongside other issues and I will group them together and make referrals.

Keyworker 4002, paragraph 65

Subtheme 3: parent engagement

Keyworkers described features that helped them to discuss potential trial participation with parents. Despite some misgivings about trial design and concerns about parents’ personal difficulties, many keyworkers adopted a direct and open approach to discussing participation with parents:

It was really straightforward to just talk to them about where they’re struggling and what it would be like if the situation was better and more positive, and the service will help [to make] it a bit easier to find strategies to manage behaviour.

Keyworker 4002, paragraph 15

Introducing the trial and possibility of referral was easier when keyworkers felt that they had a positive relationship with the parent:

So, in terms of trying to introduce other aspects of help, like your service, it was relatively easy because she kind of had that trust in us.

Keyworker 4003, paragraph 31

Keyworkers also felt that the invitation of the trial was more likely to be effective when offered as a positive, strengths-based opportunity for parents rather than as a deficit, punitive or stigmatised referral:

What helps is when you have something that you can say, ‘This is not related to social services, this is just a resource to help with these particular issues and to kind of understand what your needs are . . .’

Keyworker 4007, paragraph 55

The Helping Families Programme-Modified

A total of 18 (85.3%) participants who received the HFP-M completed the WAI-SR at T2, providing information about the quality of therapeutic relationships developed during the HFP-M.

The mean WAI-SR total score was 73.8 (SD 10.4) and mean subscales scores were consistent [WAI-SR tasks subscale score, 24.9 (SD 3.5); WAI-SR bond subscale score, 24.9 (SD 3.9); WAI-SR goals subscale score, 23.9 (SD 4.1)]. Post hoc scrutiny of the WAI-SR scores between sites suggested a possible difference in alliance quality [site 1, n = 13, WAI-SR total mean = 77.7 (SD 5.5); site 2, n = 5, WAI-SR total mean = 63.8 (SD 14.0)].

The three items most commonly receiving a rating of very often/always were Bond item ‘My therapist and I trust one another’ (n = 17, 94.5%), Goals item ‘My therapist and I are working towards mutually agreed upon goals’ (n = 16, 88.9%) and Tasks item ‘We agree on what is important for me to work on’ (n = 16, 88.9%).

Usual-care Being a Parent session

A total of six (40.0%) out of 15 usual-care participants completed the WAI-SR at T2. The mean total WAI-SR score was lower, at 56.2 (SD 18.8), for the usual-care participants. Mean subscales scores were also consistently lower than in the intervention arm [WAI-SR tasks subscale score, 17.4 (SD 7.2); WAI-SR bond subscale score, 19.8 (SD 7.1); WAI-SR goals subscale score, 19.0 (SD 7.6)].

The three WAI-SR items most commonly receiving a rating of very often/always were all from the Bond subscale: ‘I believe my therapist likes me’ (n = 4, 66.7%), ‘I feel that my therapist appreciates me’ (n = 4, 66.7%) and ‘My therapist and I trust one another’ (n = 4, 66.7%).

Comparison between the Helping Families Programme-Modified and usual-care Working Alliance Inventory-Short Revised scores

There appeared to be a substantial difference in the WAI-SR scores between the two conditions but there were insufficient usual-care data to test for a statistical difference.

Subtheme 1: intervention format

This subtheme reflected participants’ experiences of the structural characteristics of the interventions provided in both arms of the trial. The majority of the HFP-M recipients found its structure engaging and appropriate. Participants were generally more critical of the usual-care session format. Participant experiences appeared to be influenced by their intervention expectations and the characteristics of the research therapist providing the intervention.

Subtheme 2: intervention content

This subtheme reflected parents’ lived experience of the psychoeducational content and therapeutic methods of the interventions offered in the trial, including the interpersonal techniques used by therapists, the helping process, the intervention strategies and the subject matter.

Subtheme 1: clinical and service user relevance

The aims and format of the HFP-M received strong support from interviewees. The HFP-M was frequently seen as an additional service component that complemented keyworkers’ own practice and addressed a significant gap in parenting provision:

We saw it like as an additional intervention, additional help for the family, parenting and supporting the mother . . . we do need to refer to services that will offer support for parents not just for children.

Keyworker 4009, paragraph 51

A key feature giving the HFP-M credibility was its focus on the connections between parent mental health functioning, parenting and child outcomes, combined with its specialised content:

Something that’s flexible, that will go to the parents . . . that understands the parents’ difficulties, especially with parents that have difficulties regulating their emotions and their relationships. You know you’ve got practitioners that are able to sit with that parent through that and help them think about their parenting.

Keyworker 4006, paragraph 85

It seems to fit a lot better for these parents, we just don’t have either the training, the resources or it’s just not something we offer.

Keyworker 4010, paragraph 38

Subtheme 2: home-based, individualised format

Referring keyworkers supported the home-based format of both interventions, which they felt improved engagement and was distinctly different from routinely available care:

We’d obviously tried to bring it together but if they weren’t coming that often and if only one of them could turn up it was hard. Whereas I felt the family did really well. It was because both of them could be seen in the home and so parenting differences could be discussed more frankly and things tried out that could try to do.

Keyworker 4017, paragraph 15

They also felt that a home-based format potentially offered a more authentic environment in which to help parents compared with the use of clinic locations:

Having somebody coming in, doing a parenting intervention within the home . . . you are offering that intervention, and that advice, and support in a live space, where it happens all the time. That was great.

Keyworker 4015, paragraph 17

Keyworkers saw the potential value of an individualised format being a good fit for parents with significant interpersonal difficulties and low self-confidence, who they felt may not engage in traditional group-based parenting programmes:

Not everyone likes group work and that will put a lot of parents off, if they’re struggling with their confidence, if they’re not great at managing relationships and their emotions. Sometimes going into a group is really overwhelming.

Keyworker 4006, paragraph 111

Parent contacts

General practitioners (GPs) had the highest percentage of contacts, > 89% in both groups, followed by contacts with a social worker, > 44% in both groups (see Appendix 11). Health service costs were highest for day hospital, clinical psychologist and GP contacts in the HFP-M group. The highest costs in the usual-care group were for inpatient admissions, followed by day hospital and psychiatrist contacts. The mean numbers of contacts and days in the tables in Appendices 11 and 12 are for those participants with at least one contact and exclude participants not using any of the specific services.

Child contacts

The service most commonly used by children, reported by parents, was general practice, with > 50% of contacts for both groups (see Appendix 11). The costs of services used by children in the HFP-M group were generally higher than those for the usual-care group. There were, however, some instances where the usual-care arm had higher service costs, such as for hospital, home help support and dental services.

Parent contacts

Over 90% of the HFP-M group had a contact with a GP, compared with 57% in the usual-care group. Overall, the HFP-M group had a greater consumption of resource use than the usual-care group and consequently higher costs (see Appendix 12).

Child contacts

When focusing on the services used by children, a similar pattern to that of parents was observed. The HFP-M group had a higher number of contacts with the majority of services than usual care and, therefore, higher costs. The services with the highest rate of use in the HFP-M group were contacts with school nurses, GPs and after-school clubs; 50% of individuals had contacts with these services. The services with the highest use in the usual-care group were contacts with dentists and GPs, with over 50% of the sample having such contacts (see Appendix 12).

Parents

In the HFP-M group, an improvement was seen at each time point in terms of the EQ-5D-5L utility score (see Appendix 13, Table 21). The usual-care group experienced a small loss in utility score between T1 and T2; however, an improvement in utility score was later seen between T2 and T3. The HFP-M group was associated with higher QALYs than the usual-care group.

Children

The HFP-M group experienced slightly greater QALYs than the usual-care group. Children in the usual-care group saw an improvement in utility score at each time point (see Appendix 13, Table 22). At T2, there was a decrease in utility score for the HFP-M group; however, a larger increase in utility score was observed at T3. This is probably a result of outliers influencing the relatively small sample.

Subtheme 3: intervention impact and outcomes

This subtheme described the personal and family effects that parents experienced as result of participating in the trial interventions. These impacts predominantly focused on behavioural, cognitive and emotional changes in parenting, parental confidence, the index child and the parent–child relationship. Positive impacts were generally, although not consistently, described by participants who received the HFP-M. Fewer positive impacts were reported by parents in the usual-care arm.

Changes in parenting behaviour included increased parental consistency and boundary setting, and less use of physical and harsh punishments:

My daughter would watch TV [television] every morning before school . . . which meant that she wasn’t eating her breakfast, everything was taking much longer so I decided that there would be a house rule where in the morning on school days the TV wouldn’t go on to watch children’s TV. And the whole nine months, I pretty much kept to that.

Participant 2004, paragraph 58

So, before I was kind of grounding her for the whole week. And [the research therapist] kind of explained to me, like poor child . . . it’s a lot. So, if she does one thing or two things, focus on those things and give her praise for those things and kind of still address the negative. Discuss it, but make it short and then draw a line and leave it and move on. And so that was one of the things that I used that was very helpful.

Participant 1030, paragraph 85

When I used to do it [use physical punishments], I used to, you know, feel sorry . . . because that’s the last thing I want to do but when [the research therapist] talked to me and, you know, I don’t do it anymore. It makes me feel so good.

Participant 1024, paragraph 156

Parents described greater involvement with their children and increased use of positive attention and praise:

Not focusing on everything that she does bad and focusing on the good stuff as well has helped a lot . . . It was easy for her just to get bad attention . . . now she knows that the attention is there and she doesn’t have to be bad to get attention. It’s calmed down a lot.

Participant 1016, paragraph 123

The changes parents described in their children included fewer tantrums, fights and aggressive outbursts:

There’s a few things that we came up with, like dealing with [my child] and when she goes into her tantrum, and sort of things like ignoring her and that. ’Cause me and [my child] used to get into some really terrible arguments and in the last, two months’ things have really actually changed.

Participant 1003, paragraph 147

She was like constantly disrespectful, just constantly, constantly, constantly and speak back to me and it was just really hurting me. But now, I’m not saying she don’t do it but not as often and I would talk to her about it and say to her that’s not nice and things like that and she kind of understands now.

Participant 1020, paragraph 115

Parents also described changes in their relationships with their children, characterised by greater warmth, communication, role delineation and an increased emotional-cognitive capacity to more accurately understand and appreciate their children’s needs:

. . . [the research therapist] says ‘If she’s quiet, don’t just leave her be, let her know that you’re still thinking of her’ so she’s like not craving the attention, you know, she don’t feel like she has to shut herself in her bedroom and, like, play with her toys and stay away from us and plus it makes [the child] feel good, I mean, you look round and say ‘Alright babe’ and she thinks ‘Oh they’re still thinking about me’. You know, little things like that go a long way.

Participant 1016, paragraph 112

[The research therapist] . . . helped me to, kind of, understand how relationships work . . . one of the things I remember [the research therapist] saying to me ‘It’s our relationship, think of it as a plant and every day you water it and get a bit of sunshine and it will grow’. So, don’t force it, just allow it to happen and it has yeah.

Participant 1030, paragraph 101

Before I was not a mum, I was a mate to my kids, I was never a mum. I was their mate so there was no rules ‘cause I kind of lost the mum control. I became more of their friend which never worked, ever.

Participant 2009, paragraph 129

Parents, predominantly in the intervention arm, described improvements in their own emotional regulation:

When before . . . I was maybe kind of quick to get mad and just you know scream and stuff like that. Now I don’t, not as often, and I try my best to understand where they’re coming from.

Participant 1020, paragraph 115

Yeah, breathe or just come out the room for a bit and then go back.

Participant 1021, paragraph 93

You know, you just need to talk, just stick to what you say and that’s it and it works. And try and calm when you’re talking because if you’re not calm when you’re talking then you’re just going to boil up like that and you want to burst out. So, [the research therapist] said, ‘Just try and be calm and talk’.

Participant 1024, paragraph 164

This often involved parents changing their feelings about parenting tasks that they had previously found difficult as well as interpreting the needs of their children differently:

I feel like, if you’ve just come in from somewhere like work or whatever and your children are all like, ‘Oh mum this happened, that happened, oh mum can you get this? Can you do this? Can you do that?’ . . . I think you have to sort of like take a step back and think ‘Right, I’m just gonna spend 10 minutes to relax’. And then obviously, ‘cause you’re so relaxed and you’ve unwound, unwound you can then . . . deal with things better.

Participant 1008, paragraph 69

With these changes, parents often described a greater preparedness and ability to see things from their children’s perspective. This often gave parents a greater awareness of how their own behaviour affected and exacerbated their children’s difficulties:

I mean even . . . noticing things about him, . . . he’s just so angry and so rude to me . . . but I’m rude to him too and that’s probably why he’s like that and it doesn’t help, you know, and to just realise those kinds of things, which in those sessions I did, about [my child] as well . . . the dad.

Participant 1018, paragraph 171

The psychoeducational content also helped parents to gain better understandings of their parenting role, and more accurate expectations of their children’s developmental needs:

The reassurance that it’s not all my fault . . . that as a parent, sometimes, there isn’t a right thing you can do. [Knowing children’s] emotions can be just as sudden as your own. Definitely the reassurance of knowing that I’m not alone and I am doing the best that I can do as a mum.

Participant 1003, paragraph 75

This not only helped parents to adjust and change their parenting but also resulted in greater self-confidence, more positive views of themselves as parents, greater assurance about parenting as well as being more conscious of looking after their own needs:

It’s helped me to believe in myself. It’s heartening to understand how my children are feeling, it’s helped me to be able to help them, to need to be a better parent, it’s helped me. It’s opened a gate for me to be more optimistic towards my children, to understand how they feel and their feelings.

Participant 1036, paragraph 59

I feel loads better, I feel more confident . . . I just feel like I can handle more situations. So, now, where I got my confidence back and stuff, and then I learned how to say ‘no’, I learned how to say ‘no’, that was the hardest one.

Participant 2009, paragraph 129

Subtheme 3: parent experience and outcome

Based on their experience of the trial, the majority of keyworkers would have been likely to refer other parents to the trial and interventions if the opportunity arose again:

There was nothing that would put me off referring on again for the right client.

Keyworker 4014, paragraph 45

The majority of referring keyworkers described parents’ positive experiences and impacts of intervention participation:

[The participant] spoke very highly of the work that you did with her.

Keyworker 4003, paragraph 21

She was happy to have insight and support into her mental health really.

Keyworker 5002, paragraph 47

She was disappointed but she actually found that the one-off session . . . she reported back saying it had given her loads of ideas and she found it quite helpful.

Keyworker 4016, paragraph 27

However, some keyworkers were unable to assess impact as they no longer had contact with the parents and their families:

A lot of these families are now closed. I’d assume that a lot of the issues must have been addressed, because [there are] no longer had concerns.

Keyworker 4002, paragraph 69

I only saw her for an assessment and then she was allocated to a counsellor within our team. So, the only contact I had with her [was] when I . . . agreed with her that we’re going to make this referral.

Keyworker 4014, paragraph 65

Phase 1: intervention and research evaluation development

Findings from the phase 1 scoping review, service user and keyworker consultation were used to modify the existing HFP and PEPS manualised interventions to create the specialised psychoeducational HFP-M intervention. A preliminary screening process for the identification and recruitment of parents meeting research diagnosis of personality disorder was produced.

The HFP-M manual development was guided by the TIDieR checklist, including in-depth understanding of symptomatic difficulties and experiences of the target population, use of the MDP conceptual model as a pragmatic, differentiated ecological description of the inter-relationship between parent, child and parenting outcomes for the target population, current organisation and provision of relevant care, methods to engage practitioners and eligible parents in the HFP-M and its evaluation, specification of the HFP-M format and content, and methods to co-ordinate the HFP-M with usual care.

Phase 2: pre-trial feasibility testing

Phase 2 completed a small case series to test the HFP-M with parents meeting a research diagnosis of personality disorder. Findings provided preliminary support for the rationale, aims, format and content acceptability for the HFP-M and they provided a sufficient basis on which to proceed to the planned randomised feasibility trial. Case series findings suggested changes to the proposed recruitment and screening methods, particularly the use of non-diagnostic eligibility criteria and the extension of recruitment to children’s social care teams. The case series also identified potential threats to the programme delivery, such as the often fluctuating life circumstances of the target population.

Phase 2 produced an account of usual parenting support for the target population that was used to inform feasibility trial planning. A training programme for selected research therapists was completed. A range of research information and case co-ordination materials were produced to assist identification, engagement and case management of eligible parents.

Phase 3: randomised feasibility trial and process evaluation

The final research phase completed a randomised feasibility trial that assessed revised research procedures and the acceptability of the HFP-M and usual-care Being a Parent interventions. 152

Synthesis of quantitative and qualitative results broadly supported the feasibility of trial methods and identified areas to address in a subsequent definitive trial. 71,72 The HFP-M proved to be largely acceptable to participants despite delivery duration being longer than planned. The usual-care condition was less acceptable to participants, with some associated effects on trial retention.

Effects were identified across both trial arms, with some potential advantage for the HFP-M. Results produced indicative variance estimates for parent and child outcomes and measured intervention and participant service costs. Caution was required for the interpretation of results, owing to lower than expected sample recruitment and retention. Cross-sectional process evaluation provided a fine-grained understanding of key contextual factors that affected the conduct of the trial and its interventions.