One-to-one volunteer befriending to reduce symptoms of depression in people with intellectual disability: a feasibility RCT

Article history

The research reported in this issue of the journal was funded by the PHR programme as project number 16/122/57. The contractual start date was in July 2018. The final report began editorial review in September 2020 and was accepted for publication in May 2021. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Copyright statement

Copyright © 2021 Ali et al. This work was produced by Ali et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

2021 Ali et al.

Background

Aims and objectives

The main aim of the study was to determine the feasibility and acceptability of a full-scale RCT to estimate the effectiveness of one-to-one befriending by volunteers for people with ID, compared with an active control group.

The objectives were to:

• examine the recruitment and retention of individuals with ID and volunteers in the trial, and number of successfully matched pairs within the 6-month study recruitment period

• record any negative consequences/adverse effects of befriending

• measure the extent to which the intervention is delivered as intended by the volunteers and befriending schemes

• examine the acceptability of the intervention and study procedures by exploring the views of individuals, volunteers, carers and befriending services

• examine changes in health and social outcomes by carrying out exploratory analyses of the impact of befriending on depressive symptoms measured by the GDS-LD42 at 12 months and other outcomes (e.g. self-esteem, loneliness, quality of life and social participation) at 6 and 12 months post randomisation

• carry out exploratory analyses of the impact of befriending on volunteers’ well-being, self-esteem, loneliness and attitudes towards people with ID at 6 and 12 months

• estimate the sample size required and determine the final trial design for a full-scale RCT

• assess the feasibility of collecting data that would inform a future analysis of cost-effectiveness.

Design

The study design was a two-arm, parallel-group, researcher-blind pilot RCT with 1 : 1 allocation. Participants were randomly allocated to either the intervention group, where they received one-to-one befriending by a volunteer, or an active control group. Both groups had access to usual care and a booklet of local resources. A process evaluation, based on mixed methods, was conducted to examine the delivery and adherence to the intervention, and to explore stakeholder views on the acceptability of the intervention.

Eligibility criteria

To be enrolled to the study, participants with ID had to:

• be aged ≥ 18 years

• have mild or moderate ID (i.e. an IQ of 35–69) assessed using the Wechsler Abbreviated Scale of Intelligence™ (Second Edition) (WASI-II™)44

• not be attending college/education or a day service for ≥ 3 days per week

• have obtained a score of ≥ 5 on the GDS-LD,42 indicating the presence of depressive symptoms, but did not need to have a clinical diagnosis of depression

• be able to speak English

• be able to provide informed consent.

To take part in the study, volunteers had to be:

• aged ≥ 18 years

• available once per week for at least 1 hour, over a period of 6 months.

Volunteers did not need to have any prior experience of supporting people with ID.

Sample size

We did not have any estimates of the number of people with ID who were likely to be eligible and consent to taking part in the trial. If we approached 50 participants who were eligible to take part, this would allow us to estimate an expected recruitment rate of 80% (40 people), with a 95% CI of 68.9% to 91.1%. A sample size of 40 recruited people with ID would allow us to estimate a 30% dropout rate in the trial, with a 95% CI of 25.7% to 54.3%. The recruitment period was 6 months. There were two participating befriending services and, therefore, we needed to recruit 3.3 participants with ID per month at each site.

Recruitment

The recruitment period for the trial was from mid-April 2019 to mid-September 2019 (5 months). Recruitment issues are discussed in Chapter 3.

Two befriending services agreed to take part in the study. One was based in east London (Outward, based in Hackney) and the other was based in Suffolk (The Befriending Scheme). They were responsible for recruiting and training volunteers, matching volunteers to participants with ID, the provision of supervision to volunteers and monitoring of the befriending relationship. Both services had previous experience of supporting befriending relationships with people with ID.

Randomisation

Following the baseline assessment, details of the participant with ID were entered into a web-based randomisation system hosted by sealed envelope™ (Sealed Envelope Ltd, London, UK) by a non-blinded member of the research team. The randomisation procedure used randomly varying block sizes, stratified by befriending service. The randomisation protocol was created by the trial statistician and the set-up of the service was overseen by the Priment Clinical Trials Unit.

Participants were randomly allocated by the system to either the intervention group or the control group. The unblinded researcher informed the befriending service and participants with ID of the group to which they had been allocated. Owing to the nature of the intervention, it was not possible to blind participants to their assigned allocation group. However, outcome assessments were carried out by a research assistant who was blind to the participants’ allocation group.

Intervention group

Participants who were allocated to the intervention group were contacted by the volunteer co-ordinator, who arranged to meet them to discuss their hobbies, interests and activities that they would like support to participate in. Based on this information, participants were matched to a volunteer who could accommodate the person’s interests and availability.

The befriending intervention

Frequency and types of activities

The befriending intervention was adapted from the existing models used by the two participating befriending services and from other studies of befriending. 37,40 The purpose of the befriending relationship was to provide friendship and emotional support, to facilitate community access, and to help the individual gain skills and confidence that would allow them to access activities in the community on their own (i.e. to promote sustained social activities beyond the befriending relationship). Figure 1 is a logic model of the intervention and describes the proposed mechanisms of action.

FIGURE 1.

Logic model of befriending in people with IDs.

The volunteer (befriender) and person with ID were expected to meet once per week for at least 1 hour, over a period of 6 months. However, it was anticipated that there may be breaks due to holidays or illness. The pair received a booklet with information about local activities and amenities, which was to be used as an aid to plan activities. The emphasis was on assisting the individual to make choices about the activities that they wished to pursue. The volunteer was not expected to carry out personal care, administer medication or accompany the individual to medical appointments. Contacts by telephone/social media were permitted in addition to face-to-face contact, and the pair were expected to spend at least 50% of the total number of meetings in the community. Meetings could take place during evenings/weekends, depending on the pair’s availability. Volunteers were asked to keep a record of their activities in a structured log, detailing whether or not they attended, reasons for cancellation, what they did at each visit, the duration of the activity and types of contact other than face to face. Volunteers’ travel expenses were reimbursed, but other expenses had to be agreed with the befriending service. Participants with ID were expected to pay for their travel and the other costs they incurred during outings.

Introduction and monitoring of the befriending relationship

A face-to-face meeting was arranged by the volunteer co-ordinator at the participant’s home to introduce the volunteer to the participant. If both parties were satisfied with the matching process, the pair then arranged to meet on their own. If the volunteer or individual with ID dropped out of the relationship once it had become established, they were offered the option of rematching. Volunteers were permitted to be matched to more than one participant with ID, although this did not occur in the trial.

Six weeks after matching, the volunteer co-ordinator contacted each person by telephone/face to face and then maintained contact every 4 weeks to monitor the progress of the relationship. A further meeting was held with the pair towards the end of the 6-month period to obtain general feedback about the befriending intervention, to discuss ending the relationship and to support the individual with ID in coming to terms with the ending. The pair could continue their relationship if they wished after the 6-month period was over, but arrangements for monitoring the relationship were outside the remit of the trial and varied according to the befriending service. Information was collected on any relationships that had continued beyond 6 months.

Training and supervision of volunteers

Volunteers completed face-to-face training and electronic learning prior to being matched. The training covered the following topics: benefits of befriending and issues related to confidentiality and lone working; advice on how to plan meetings effectively; health and safety; safeguarding; intellectual (learning) disability awareness, and professional boundaries, such as dealing with sensitive issues, ending relationships and expectations of the role of the volunteer. Volunteers received PowerPoint (Microsoft Corporation, Redmond, WA, USA) slides and a manual developed by the research team, with information about the study and additional information relevant to working with people with ID, such as maximising communication, understanding the reasons for challenging behaviour, common mental health problems and what volunteers should do in an emergency.

Volunteers had access to individual supervision with the volunteer co-ordinator, which was delivered face to face or over the telephone once per month. The supervision sessions addressed issues related to the training needs of the volunteer and how to overcome issues that had arisen from the befriending relationship.

Training and support for befriending services

The two befriending services completed good clinical practice training and received training on the trial research processes and procedures as part of the site initiation visit. Volunteer co-ordinators received support from the research team through regular e-mail and telephone contact, and were members of the Trial Management Group.

Control group

To control for the effects of participants in the treatment group receiving more information about local activities than those in the control group, participants in the control group were also given a copy of the activities booklet, and met with a member of the research team who discussed the booklet with them (and their carer, if present) and encouraged them to engage with activities.

Both the control group and the intervention group had access to ‘usual care’. This included access to multidisciplinary input from community ID services, including appointments with their psychiatrist, psychologist and other members of the team. Participants continued to take their usual medication, which included antidepressants and antipsychotics. They had access to primary care and other community and hospital-based health services, as well as day services (e.g. day centres and colleges). Where it was possible, participants in the control group were asked if they wished to be matched with a volunteer after they completed their follow-up assessment.

Outcomes

Process evaluation

A process evaluation using mixed methods59 was conducted to examine:

• Adherence (fidelity) to the intervention: whether or not the different components of the intervention were consistently followed and the extent to which volunteers delivered the intervention as intended

• Acceptability of the intervention and trial procedures. The aim was to understand the perceived value, benefits and unintended consequences of the intervention; to understand the contextual factors influencing how the intervention was delivered; and to develop an understanding of the likely mechanisms of action of the intervention and what modifications that would need to be made to the trial procedures and processes in a future randomised trial.

Study expenses

Following completion of the baseline assessment and, again, after the 6-month follow-up assessment, all the participants and volunteers received a £15 gift voucher for their time and effort. Participants taking part in the qualitative interviews also received a £15 gift voucher.

Data management

Quantitative data were collected using the study CRFs, which were stored at the study sites. Data were entered into the secure and General Data Protection Regulation-compliant60 Red Pill (web-based) database hosted by Sealed Envelope Ltd and managed by Priment Clinical Trials Unit. A subsample of 5% of the CRFs was checked to ensure consistency in data entry. After completion of relevant data management processes, the data were exported from the database and analysed by the trial statistician.

Statistical analysis

Demographic and clinical characteristics of participants with ID and their mental health, quality of life and social outcomes were summarised by randomised group using mean [standard deviation (SD)] or count (percentage) for continuous and categorical data, respectively, at baseline and at the 6-month follow-up.

Demographic characteristics of befriending volunteers and their mental health and attitudinal outcomes were similarly summarised at baseline and at the 6-month follow-up.

The primary mental health outcome was depressive symptoms, measured using the GDS-LD. All participants were analysed in the groups to which they had been randomised. The effect of the befriending intervention was estimated using a linear regression model, with depressive symptoms at 6 months’ follow-up as the outcome and study group as the main explanatory variable, adjusting for depressive symptoms at baseline.

Owing to the small number of participants recruited to the study, we decided that it was inappropriate to explore the effect of the intervention on the secondary outcomes and further regression analyses were not conducted

Analysis of cost-effectiveness

The main aim of the economic evaluation was to determine the costs of delivering the intervention, and test the feasibility of collecting health-care resource use and health-related quality-of-life data to calculate the incremental mean cost per quality-adjusted life-year (QALY) gained from the intervention, compared with the control (i.e. the cost-effectiveness), in people with ID for a full RCT. The detailed health economic analysis is described in Appendix 2.

We assessed the response rates from the CSRI, EQ-5D-Y and EQ VAS; and collected information on whether the CSRI was completed by carers, professionals or participants with ID. We noted any difficulties reported by participants in completing these measures.

The costs of the intervention were provided by the volunteer co-ordinators at the befriending services. They provided a breakdown of costs related to the intervention, such as costs of recruitment, DBS checks, and staff time in relation to training and supervision of volunteers and monitoring visits. Staffing costs were calculated using an hourly rate.

To calculate the costs of using health and social care services, we adopted the perspectives of the NHS and Personal Social Services. The horizon of the study was 6 months; therefore, discounting was not performed.

The mean (SD) health and social care resource use and costs of medication were calculated and costed using nationally recognised, published unit costs61–63 to estimate the mean (95% CI) costs per participant. Costs were in Great British pounds at 2019 values or adjusted for inflation if costs for 2019 were not available (see Appendix 2, Tables 10 and 11, for unit costs and prescription costs).

Responses from the EQ-5D-Y were converted into a single value (index number). The collection of index values for possible EQ-5D states is referred to as the value set. Research is currently ongoing to produce EQ-5D-Y value sets and, therefore, although not recommended, the regular EuroQol-5 Dimensions, three-level version (EQ-5D-3L), value sets were used to obtain utility values. Utility values range from 0 to 1, with scores close to 1 indicating ‘full health’ (with a score of 0 indicating ‘death’). The EQ VAS was used as a quantitative measure of health outcome that reflects the participant’s own judgement about their health status. We examined whether or not scores on the EQ VAS were consistent with the EQ-5D-Y utility values, as this would help us to determine if the EQ-5D-Y is a suitable measure of health status in people with ID.

Incremental cost per change in the primary health outcome (depression scores on the GDS-LD) between the intervention group and the control group was estimated. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference in total costs (incremental cost) by the difference in the health outcome (incremental effect) to provide a ratio of ‘extra cost per extra unit of health effect’ for the more expensive intervention compared with the alternative. ICERs reported by economic evaluations are compared with a predetermined threshold to decide whether or not choosing the new intervention is an efficient use of resources.

Analyses followed the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Good Reporting Practices. 64

Qualitative data analysis

Transcripts from the interviews with participants with ID, staff at befriending services, volunteers and carers were transcribed and analysed using thematic analysis65 supported by computer software (NVivo 9; QSR International, Warrington, UK). Thematic analysis aims to identify themes or patterns in the data set through a rigorous process of data familiarisation, coding of data, and the development and refinement of themes. It was selected because of its flexibility in incorporating a range of different approaches and its use in a wide range of contexts. Data were coded by two members of the research team, using both deductive (i.e. coding guided by existing concepts and ideas) and deductive (i.e. coding guided by the content of the data) approaches. The codes and initial themes were discussed with the research team, followed by further revision of themes. The analytic strategy aimed to identify themes related to the barriers and facilitators affecting the implementation of the intervention, potential benefits to participants and volunteers, and possible mechanisms of action. Analysis also allowed for the consideration of themes that arose more inductively from the data. The reliability of the coding frame was not assessed.

Progression criteria

The following criteria were used to evaluate whether or not the pilot trial had been successful:

• At least 70% (35) of participants are recruited from the 50 potentially eligible individuals who are approached.

• At least 70% of participants with ID in the intervention group are successfully matched to a volunteer (befriender) and they meet on a minimum of 10 occasions.

• The dropout rate of participants with ID in both groups, post randomisation, is < 30% at 6 months’ follow-up.

• The intervention and trial procedures are considered to be acceptable by volunteers and individuals with ID.

• If the target recruitment rate and number of matched pairs is between 50% and 69%, or the dropout rate is between 31% and 50%, we would consider if these could be rectified by modifying the protocol. If this was the case, a full study could still be considered. If the recruitment rates were < 50% and the dropout rates were > 50%, then a full trial would not be considered feasible.

Management of the study

The study was sponsored by University College London. The study research assistant was supervised by the chief investigator and they met weekly. The Trial Management Group, comprising the research team, co-applicants, and staff from the two befriending schemes and Priment Clinical Trials Unit, met every 3 months. An independent Trial Steering Committee, comprising five members [an academic clinician, clinician in ID, statistician, health economist and patient and public involvement (PPI) representative] was appointed and approved by the funders. Meetings were held annually and minutes were made available to the funders.

Patient and public involvement

Ethics issues

The study received ethics approval from the London – City and East Research Ethics Committee (reference 18/LO/2188) and from the Health Research Authority (HRA) on 8 January 2019. All substantial amendments to the study were approved by the sponsor and were submitted for ethics approval. Participants with ID were provided with an accessible information sheet and were required to provide written consent prior to taking part in the study. Volunteers, volunteer co-ordinators and carers were also provided with an information sheet and were required to give written consent. Data confidentiality was maintained by assigning participants study identification numbers. One of the main concerns about the study was the potentially negative impact on the participant with ID of relationships ending, particularly if they had limited access to other forms of support. Unfortunately, it was not possible to explore these issues in detail as we were unable to complete the 12-month follow-up (reasons for which are explained in Chapter 3).

Several ethics issues arose during the study. First, the Suffolk befriending service raised concerns about the randomisation of participants and expressed the view that it was unacceptable to assign participants to the control group. To manage this issue, it was agreed that individuals referred to the service would have the option of taking part in the study or remaining on the waiting list. This had significant consequences for recruitment (discussed further in Chapter 3). Second, carers were occasionally found to obstruct relationships and, on two occasions, appeared to be responsible for the breakdown of the befriending relationships. This situation was distressing for the volunteers. In both cases, the participant with ID did not express dissatisfaction with the relationship. This raises questions about the lack of autonomy that some people with ID may have in making decisions. Finally, one safeguarding alert was raised by a volunteer when their befriendee reported being bullied by a paid carer (discussed further in Chapter 3).

Overview of issues encountered in recruitment

The study began in July 2018 and was funded for a 2-year period. In the original study Gantt chart, we had aimed to obtain all the necessary approvals (i.e. approval of the protocol by Priment Clinical Trials Unit, sponsorship and ethics approval, exchange of site contracts and approval of the study database) and start recruitment within 4 months of the trial start date. This target proved to be unrealistic and, as a result of delays in obtaining the necessary approvals, recruitment did not begin until April 2019, 6 months later than intended. Recruitment was slow, and the number of participants with ID who were eligible or willing to take part was smaller than anticipated, as was the number of volunteers expressing an interest in taking part in the study. One issue that we encountered with recruitment through the Suffolk scheme was that it was not considered to be appropriate (or acceptable) by the scheme to change the current standard of practice, because of concerns over randomisation and the potential allocation of participants to the control group. This issue was raised after the protocol was approved and sponsorship approval had been given. It was agreed that the scheme could offer individuals the option of entering the study or remaining on the waiting list for a befriender. Owing to the uncertainty of whether service users would be allocated a befriender or be in the control group, those who were approached chose to remain on the waiting list until a volunteer was allocated through the usual route, even if it meant waiting for a longer period. Staff at the service also expressed their discomfort at the possibility of participants being left in the control group without a befriender for a year. To manage this situation, we agreed to make changes to the protocol to permit participants in the control group to be allocated a befriender after they completed their 6-month follow-up. It was not possible to change the design of the study (e.g. to a waiting list control group) because of the time frame and delays to the study, as this would have required significant changes to the protocol and approval from the funders.

A number of changes to the protocol were made to improve recruitment (see Protocol changes and amendments), such as recruiting student and staff volunteers directly through University College London and the study website, and recruiting participants through advertising on posters, but these strategies did not contribute to an overall improvement in recruitment. Further changes to the study protocol were also considered, such as expanding the number of befriending services taking part in the study and introducing patient identification sites, but these changes were not implemented as the study funders did not approve extending the recruitment period, which would have also required a costed extension to the trial duration and study end date. In September 2019, the funders communicated to the chief investigator that recruitment should close and that preparations should be made to end the study in June 2020, which was the expected end date. The chairperson of the Trial Steering Committee was consulted for advice. With this time frame, it was not possible to complete the 12-month post-randomisation follow-up outcome assessments, and the protocol was updated to reflect this change. Owing to the COVID-19 pandemic, there were some delays in conducting the qualitative interviews and, therefore, a no-cost extension of 2 months was granted.

Recruitment and retention of participants

The flow of participants with ID in the pilot trial is shown in the Consolidated Standards of Reporting Trials (CONSORT) flow diagram (Figure 2). Twenty-four potential participants were referred to the study team. Fifteen referrals were from NELFT clinicians, six were from Outward (Hackney) and three were from The Befriending Scheme (Suffolk) (Table 1). The number of participants with ID and volunteers who were recruited each month is shown in Table 2. On average, just under three participants (2.7) and two (1.7) volunteers were recruited each month into the study. Of the 24 participants with ID referred to the study, 21 were assessed and five were excluded (1) because they did not meet the inclusion criteria (n = 3), (2) because they declined to take part (n = 1) or (3) because of challenging behaviour that may have put the safety of volunteers at risk (n = 1). Sixteen participants agreed to take part in the trial and were randomised to either the intervention group (befriending, resource booklet and usual care; n = 8) or the control group (resource booklet and usual care; n = 8).

FIGURE 2.

The CONSORT flow diagram for participants with ID.

Of the eight participants who were randomised to the intervention group, six received the befriending intervention. It was not possible to match two of the participants with a volunteer; the reasons for this were geographical distance (no local volunteer could be identified) and, in one case, deterioration in the mental state of the participant prior to matching.

Of the six participants who were matched, only four had a volunteer for the whole 6-month period. One participant was matched with another volunteer after the first volunteer dropped out because of work commitments. Of the two participants who did not have a volunteer for the 6-month period, in one case the family carer was not satisfied with the match, as they felt that the interests of the participant and the volunteer were not compatible, and in the other case the volunteer experienced difficulties working with the participant because of interference from the participant’s paid carers, who were based in the participant’s supported living accommodation.

All 16 trial participants completed the 6-month follow-up, but one participant in the control group only partially completed the outcome measures owing to a deterioration in their mental state and refusal to continue the assessment.

The flow of volunteers recruited to the study is shown in Figure 3. Twelve volunteers expressed an interest in taking part in the study (nine from the Hackney site and three from the Suffolk site). Two dropped out before being enrolled in the study (one did not complete the training and one could not be contacted for their baseline assessment). Ten volunteers completed the baseline assessment, but one dropped out shortly afterwards (no reason given). Of the nine remaining volunteers, seven were matched with a participant with ID; however, one volunteer who had been matched dropped out of the study because of work commitments. Two volunteers in Suffolk were not matched, as no participants with ID were allocated to the intervention group (the only participant to be randomised was allocated to the control group). All eight remaining volunteers completed the 6-month follow-up assessments.

FIGURE 3.

Volunteer flow chart.

Baseline characteristics of participants

The average age of the 16 participants who took part in the trial was 41.6 (SD 16.7) years; nine were female (56%), eight were of white ethnicity (50%) and nine (56%) were living in supported living accommodation. The majority of the participants had a mild ID (81%), and the average IQ was 55.3 (SD 7.6). Ten participants (63%) had a clinical diagnosis of depression and five (31%) had a diagnosis of anxiety disorder. Nine participants (56%) were taking an antidepressant.

Table 3 displays the participants’ demographic characteristics according to allocated group. The participants in the intervention group were older than those in the control group [average age 48.9 (SD 17.2) years, compared with 34.3 (SD 13.4) years, respectively], were mainly female [6 (75%) compared with 3 (38%), respectively], were less likely to have a diagnosis of depression [4 (50%) compared with 6 (75%), respectively] and there were fewer multiple mental health diagnoses [2 (25%) compared with 5 (62.5%), respectively].

Table 4 summarises the outcome measures at baseline according to group allocation. Depressive symptoms at baseline were lower in the intervention group than in the control group, with mean GDS-LD scores of 18.6 (SD 5.7) and 21.4 (SD 9.8), respectively.

Self-esteem, as measured by the adapted Rosenberg scale, was higher in the intervention group (mean 22.4; SD 4.1) than in the control group (mean 20.8; SD 4.5), as was quality of life, as measured by the MANS-LD [mean 73.0 (SD 9.4) and mean 64.1 (SD 10.3), respectively] and the WHOQOL-8 [mean 30.0 (SD 4.4) and mean 23.8 (SD 4.7), respectively]. Social support, as measured by the SSSR, was similar across both groups, although the control group reported more contacts with friends [median 5.5 contacts, interquartile range (IQR) 3.5–7.5 contacts] than the intervention group (median 3.5 contacts, IQR 1.5–6.0 contacts). Social participation, as measured by the GCPLA, was 16.4 units higher in the control group (mean 73.9 units, SD 25.9 units) than in the intervention group (mean 57.5 units, SD 23.4 units).

The baseline characteristics of the volunteers are summarised in Table 5. The average age of volunteers was 33.2 (SD 11.2) years. Seven (70%) volunteers were female and seven (70%) volunteers were of white ethnicity. Six (60%) volunteers were single, seven (70%) were employed and the majority had A Level (Advanced Level) qualifications or a higher level of educational qualification (n = 7; 70%). Four (30%) volunteers had prior experience of working with someone with ID and three (30%) had experience of working with someone with mental health problems. The baseline scores on the outcome measures of self-esteem, psychological well-being, loneliness and attitudes towards people with ID are shown in Table 6.

Adverse events

There were no serious adverse events associated with the intervention for participants with ID. In the case of volunteers, there was one incident involving a disagreement between a paid carer at a supported living placement and a volunteer. The volunteer was unfairly accused of buying the participant an unhealthy meal and disregarding his care plan. This disagreement led to a breakdown in the befriending relationship and was upsetting for the volunteer. The volunteer reported this incident to the volunteer co-ordinator, who raised the issue with the manager of the placement. The manager acknowledged that there was a misunderstanding between the paid carer and volunteer.

Other incidents

A volunteer raised a safeguarding alert after their befriendee reported feeling bullied by a member of staff at their supported living placement. The volunteer supported the individual to report the incident. The incident was investigated by the local authority and the situation was satisfactorily resolved.

Outcome assessments at 6 months’ follow-up

Table 7 shows the scores on the outcome measures for participants with ID at 6 months’ follow-up. Depressive symptoms at 6 months’ follow-up were lower in the intervention group than in the control group, with mean GDS-LD scores of 12.9 (SD 6.7) and 17.5 (SD 6.5), respectively. Compared with baseline scores, there was a reduction in the GDS-LD score in both groups (3.9 units in the control group and 5.7 units in the intervention group). There was a slight increase in mean self-esteem scores in both groups: an increase of 0.6 units in the control group, to 21.4 units (SD 3.5 units), and an increase of 1.5 units in the intervention group, to 23.9 units (SD 3.4 units). Mean quality-of-life scores on the MANS-LD also increased in both groups: an increase of 7.9 units in the control group, to 72 (SD 5.5) units, and an increase of 7.0 units for the intervention group, to 80.0 (SD 9.9) units. The mean WHOQOL-8 scores in the control group increased by 4.6 units, to 28.4 (SD 3.5) units, but the scores in the intervention group decreased by 0.6 units, to 29.4 (SD 5.3) units. There were only small changes in the scores for loneliness and social dissatisfaction on the MWLQ. The median social support scores increased slightly in the control group in relation to family (an increase of 2 units, to 7.0 units, IQR 4.0–9.0 units), compared with no change in the intervention group, and in relation to friends (an increase of 1.5 units to 7.0 units, IQR 4.0–9.0 units), compared with an increase of 0.5 units in the intervention group (4.0 units, IQR 3–6.5 units). Between baseline and follow-up, the social participation score increased by 3.8 units in the intervention group (to a mean of 61.8; SD 22.5) and by 0.5 units in the control group (to a mean of 74.4; SD 20.4).

Health economic data

The total cost of intervention implementation was £5647.38 (see Appendix 2, Table 12), which includes the cost of recruitment (staff time); DBS and reference checks; the cost of staff time and resources to deliver training, supervision, monitoring calls and visits; and volunteer expenses. The mean cost per participant was £701.00.

It was possible to obtain NHS resource data from carers or from health professionals in the majority of cases, but three participants (who lived independently and had minimal support) provided self-report data. Data were available for all 16 participants at baseline and follow-up. No significant difficulties were reported by carers or participants with ID, although participants with ID may have had difficulty recalling the number of contacts with health services over the previous 6 months. Participants were encouraged to use their diaries to record this information.

The costs of NHS resource use and EQ-5D-Y health state values at baseline and at 6 months post randomisation are provided in Appendix 2, Tables 13 and 14. Health-care resource use costs at baseline were substantially lower in the intervention group (mean £1387; 95% CI £359 to £2415) than in the control group (mean £4949; 95% CI £351 to £9548). In both groups, resource use costs at 6 months’ follow-up were lower than those at baseline (mean £855 in the intervention group and mean £4014 in the control group). The mean difference in resource use costs between the two groups was –£3159 (95% CI –£6250 to –£73), but this difference does not take into account baseline cost differences. After including the intervention cost, the mean difference was –£2458 (95% CI –£5549 to £628), but was not statistically significant.

The EQ-5D-Y and EQ VAS were completed by individuals with ID. The EQ-5D-Y was completed by all participants at baseline, but data were missing for one participant at 6-month follow-up. The EQ VAS was completed by almost all of the participants (data were missing for one participant at baseline and follow-up). No issues were reported in the completion of the EQ-5D-Y descriptive system, but some participants found the instructions for the EQ VAS difficult to understand, which may explain the discrepancies in the scores between the EQ-5D-Y and EQ VAS (see below).

At baseline, the EQ-5D-Y utility value was slightly higher in the intervention group (0.90; SD 0.10) than in the control group (0.88; SD 0.08). At 6 months, it was slightly higher in the control group (0.90; SD 0.13) than in the intervention group (0.88; SD 0.11). At baseline, the EQ VAS score was substantially higher in the intervention group (75.0; SD 23.2) than in the control group (45,6; SD 31.5), but, at 6 months’ follow-up, the EQ VAS score appeared to decrease in the intervention group (62.3; SD 40.8) and increased slightly in the control group (50.7; SD 27.6). The CIs for the EQ VAS were large, and the scores did not appear to correspond well to the EQ-5D-Y utility values, suggesting that the EQ VAS may be difficult for people with ID to complete.

We have explored further the responses to the EQ-5D-Y questionnaires that are displayed in Appendix 2, Tables 15 and 16, splitting the EQ-5D-Y levels into ‘no problem’ (level 1) and ‘any problems’ (levels 2 and 3), changing the profile into frequencies of reported problems. This is helpful, as it describes the changes in health over time. Although an overall summary is preferred, this approach shows that there were improvements in usual activities; pain and discomfort; and feeling worried, sad or unhappy in the control group; and improvements in participants looking after themselves in the intervention group.

Owing to the small sample size and discrepancies in the scores, QALYs were not calculated. Therefore, the incremental cost per change in the primary health outcome (depression scores on the GDS-LD) between the intervention group and control group was estimated. After adjustment for baseline values, the ICER was –£1810 per 1-point change in GDS-LD score.

The befriending intervention has a 35% probability of being cost-effective at a willingness to pay of £20,000 (see Appendix 5, Figure 5). These results are illustrative only and should be interpreted with caution because of the small sample size.

Protocol changes and amendments

Protocol changes and amendments were approved by the Public Health Research programme manager and submitted for sponsorship and ethics approval. The main changes were as follows:

• Amendment 1 (approved on 21 June 2019): changes to recruitment to include recruitment of volunteers via the trial website, recruitment of undergraduate students at University College London and use of posters to recruit participants with ID from ID services in NELFT. Changes to the matching process were also introduced, following recommendations from the Trial Steering Committee, enabling participants to be rematched if a volunteer dropped out, and for more than one volunteer to be matched to a participant.

• Amendment 2 (approved on 25 March 2020): the 12-month follow-up was removed because of significant delays to the study. Focus groups with volunteers, carers and volunteer co-ordinators were changed to interviews to assist data collection.

Intervention adherence

Acceptability of the intervention and study processes

Twenty-five participants (12 participants with ID, five volunteers, five carers and three volunteer co-ordinators) were approached and 21 agreed to take part in interviews. Four declined participation or were unavailable to take part (three participants and one family carer). There was a total of 20 interviews (one interview was carried out with two volunteer co-ordinators at the Suffolk service owing to time constraints, as one staff member was leaving her job). There were nine interviews with participants with ID (involving five participants in the control group and four participants in the intervention group); six participants were female and three were male. There were five interviews with volunteers who had been matched (four females and one male). The three volunteer co-ordinators and four carers who were interviewed were all female (three were paid carers and one was a family member). The duration of the interviews ranged from 7.3 to 31.2 (mean 18.1) minutes for participants with ID, from 19.3 to 40.4 (mean 32.6) minutes for volunteers, from 59.1 to 89.5 (mean 74.3) minutes for staff at befriending services and from 11.2 to 44.5 (mean 31.5) minutes for carers.

Progression criteria

We listed a number of criteria that would be considered in evaluating whether or not the trial had been successful:

• At least 70% (35) of participants are recruited from the 50 potentially eligible individuals who are approached.

• At least 70% of participants with ID in the intervention group are successfully matched to a volunteer (befriender) and they meet for a minimum of 10 meetings.

• The dropout rate of participants with ID in both groups, post randomisation, is < 30% at 6 months’ follow-up.

• The intervention and trial procedures are considered to be acceptable by volunteers and individuals with ID.

• If the target recruitment rate and number of matched pairs is between 50% and 69%, or the dropout rate is between 31% and 50%, we would consider if these could be rectified by modifying the protocol. If this was the case, a full study could still be considered. If the recruitment rates were < 50% and the dropout rates were > 50%, then a full trial would not be considered feasible.

Recruitment

Retention of participants and volunteers

The retention of participants with ID who had been randomised was excellent. No participant dropped out of the study, and they all agreed to complete the outcome assessments at baseline and follow-up, apart from one participant who completed only a few measures at follow-up.

Retention of volunteers was fairly good. Of the 10 volunteers who participated in the study, only two dropped out (retention of 80%). The remaining eight volunteers completed the baseline and follow-up assessments. We therefore met our minimum criterion of < 30% dropout rate from the study.

Matching of participants and volunteers

We matched six out of eight participants in the intervention group with a volunteer (75%), which met our minimum criterion of 70%. One participant could not be matched because of geographical distance and another because of a deterioration in their mental health. One participant had to be rematched with another volunteer after the first volunteer dropped out of the study. No volunteers were matched with more than one participant. Four pairs continued their relationship beyond the 6-month period.

Adverse effects and unintended consequences

Befriending was not associated with any serious adverse events for people with ID. However, we were unable to complete the 12-month assessment and, therefore, it was not possible to monitor the impact of relationships ending on the well-being of individuals beyond the 6-month period. Four out of the six matched pairs had decided to continue their relationship beyond 6 months and the other two pairs met on only a few occasions. There was a positive outcome for one participant, who was supported to report an incident of mistreatment by a paid carer at their supported living placement. The participant may not have reported this incident without the support they received from the volunteer.

However, there were unintended consequences for volunteers. One volunteer experienced conflict with members of staff at their befriendee’s supported living placement, which arose because of a misunderstanding about the volunteer’s role. This consequently led to the volunteer becoming distressed and deciding to drop out of the study. Another volunteer was unable to continue with their relationship with the befriendee because the befriendee’s mother was not satisfied with the match. The volunteer was disappointed with this situation, particularly as the befriendee was not involved in making the decision. In both situations, the volunteer co-ordinator attempted to resolve the dispute and provided emotional support to the volunteers. Similar conflicts with staff and carers were reported in our survey of befriending services and volunteers in the UK,75 suggesting that this is not an uncommon issue encountered by volunteers. More support should be provided to volunteers to negotiate such challenging situations to prevent relationships breaking down unnecessarily, and service users with ID should be empowered to make decisions about whether or not they wish to continue with relationships, rather than these decisions being made by carers.

Adherence to the intervention

There was good adherence to the training by volunteers, and most volunteers engaged with the supervision process. The pairs were expected to meet for a minimum of 60 minutes per meeting, but this was exceeded (with an average meeting duration of 118 minutes). We set a minimum target of 10 meetings between the befriender and the participant. The average number of meetings was almost 12 (11.8) and, based on this, the minimum target was met. However, only four of the six pairs (66.7%) actually met ≥ 10 times. In Priebe et al. ’s37 RCT of befriending in people with psychosis, only half the participants met their predefined threshold of at least 13 meetings over 1 year, suggesting that implementation may be an issue in befriending trials. In our survey of befriending services for people with ID, we found that there was a large variation in the frequency of meetings, with the majority of pairs meeting for a period ranging from every 2 weeks to every other month. 75 In our study, we also stipulated that the majority of the sessions should be in the community, which did occur, but the range of activities was limited and mainly consisted of visiting cafes and restaurants, and going for walks. Trips to museums/galleries and to the cinema occurred on only a few occasions and there were no activities involving recreational activities, such as swimming or going to the gym. These findings are consistent with our survey of befriending services, which found that the most frequently reported activities involved going to cafes and restaurants, followed by visits to parks and outdoor spaces. 75 One possible explanation is that individuals with ID did not always have sufficient funds to cover activities (this was raised by several volunteers), which might have prevented pairs from engaging in more novel activities, or it may be related to difficulties in motivating individuals who have depressive symptoms. Spending time indoors and having ‘a conversation’ was also frequently reported, highlighting the role of volunteers in providing emotional support. No particular types of activities were regarded as being more pleasurable, indicating that spending time together may be more important than the nature of the activity.

Acceptability of study procedures

Volunteers were satisfied with the trial processes and procedures and thought that the questionnaires were relevant and of the right length. Some participants with ID expressed their frustration at being allocated to the control group. They thought that some of the information was difficult to understand and that the questionnaires were too long.

Acceptability of the intervention

Based on the qualitative interviews, overall, the participants and volunteers valued the opportunity to have a befriender and to take part in the study. This, alongside the very high retention rates of participants in the study and the fact that four out of the six matched pairs had plans to continue their relationship beyond 6 months, suggests that the intervention may have been acceptable, at least to those who took part in the study. We did not conduct interviews with individuals who did not want to take part in the study, and their views about the intervention may have been different. The low recruitment rate may also indicate that the intervention was not widely acceptable to people with ID who had symptoms of depression because they were anxious about meeting someone they were not familiar with or were not motivated to engage in new activities.

There were some issues with the intervention. Volunteers commented on the need for more flexibility in relation to the frequency of visits, with a preference for visits every 2 weeks rather than weekly because of other commitments. Flexibility in supervision arrangements and the nature of contacts (e.g. permitting contact via social media) was also suggested. A recent qualitative study of the experiences of befriendees and befrienders who had participated in a RCT of befriending76 highlighted the importance of having a flexible approach in relation to the role of the befriender and the nature of the intervention, and that befriending was an authentic relationship that developed over a period of time. 77 Burn et al. 77 also discovered that befriending was a considerable commitment for volunteers and necessitated balancing a number of competing commitments, which was also reported in our study. The mutual benefits of befriending was a positive finding in our trial, which indicated that we should not assume that only participants with ID will benefit from the intervention.

Another highlighted issue, which may affect the acceptability of the intervention, was the expectations of carers, who had a strong influence on aspects of the intervention, such as whether or not a match should continue (this led to one participant being left unmatched after one session) and conflict with another volunteer over their selection of activities. As discussed above, this led to two volunteers dropping out. Carers misunderstood the role of volunteers and thought that they should assume the same responsibilities as a support worker. Guidelines on how to work with carers, and clear discussions with carers about the roles and responsibilities of volunteers need to be considered. Financial issues were raised by a number of volunteers, particularly during supervision. On occasions, volunteers had to pay for the participants’ expenses during visits, as carers did not realise that these expenses were not covered. Good communication between carers, volunteers and the befriending service was considered to be essential.

Measurement of outcomes

The lower than expected recruitment rate resulted in a small sample size and unbalanced groups, despite randomisation. However, our exploratory analysis of outcome revealed a mean four-point reduction in the GDS-LD score in the intervention group, after adjusting for the baseline score, which equates to a standardised effect size of 0.5 SDs. The 95% CIs around this difference in GDS-LD score (95% CI –11.2 to 3.2 SDs) suggest that, although this is a non-significant result, an important clinical difference could be found in a main trial. However, there were baseline differences in the characteristics between the two groups and, given the small sample size and that only six participants in the intervention group actually received the intervention (a further two received one or two sessions), it may well be a chance finding. Nevertheless, the findings are similar to that of a feasibility study of mentoring in 29 people with ID and a matched comparison group. They found a reduction in GDS-LD (proxy) scores in the intervention group, with an effect size of 0.51, and this approached significance (p = 0.10). 41 This suggests that befriending may reduce depressive symptoms, but that our results should be treated with considerable caution because of the small sample size.

Previous studies of befriending in other populations have found small effect sizes in reducing depressive symptoms. 21 However, one trial of a ‘visiting service’ for elderly widows found that participants who had high levels of social isolation, two or more physical illnesses or low levels of education (no education or primary school only) responded better to the intervention, with statistically significant effect sizes of between 0.54 and 0.63 for a reduction in depressive symptoms. 76 This group shares characteristics with people with ID, suggesting that the benefits of befriending may be greater for more disadvantaged groups.

Health economic evaluation

Data collection methods for a future economic evaluation were developed, and their feasibility was tested during this study. There was a good return of the resource use questionnaire from carers. Data on intervention costs were obtained from befriending services. Participants completed the EQ-5D-Y descriptive system and the EQ VAS, but there were important discrepancies between the scores, which could make calculation of QALYs for a cost–utility analysis less reliable. The differences may have been due to a number of reasons, such as poor understanding of instructions on how to complete the EQ VAS or because the EQ-5D-Y is not an appropriate measure for adults with ID (it has not been validated for use in this group) and may not capture relevant aspects of health that are perceived to be important. In the absence of a validated measure of health-related quality of life in this population, perhaps the EQ-5D-Y should not be used in isolation to assess health-related quality-of-life outcomes in trials involving adults with ID, and should be used in conjunction with a proxy measure.

The results of our study show that the intervention has a probability of 35% of being cost-effective. These results are conservative and should be interpreted with caution because of the small sample size and other issues that affected the study.

Strengths of the study

• To the best of our knowledge, this is the first pilot study to investigate the feasibility and acceptability of conducting a RCT of one-to-one befriending by volunteers for people with ID and symptoms of depression. Other studies used a non-randomised design or did not have a control group. 40,41

• The befriending intervention was delivered by community befriending schemes. This reflected actual practice, as the majority of befriending services are not funded by the NHS and may receive only partial or no funding from local authorities.

• Although some attempt was made to standardise the intervention through the recommendation of weekly visits (each lasting at least 60 minutes, over a period of 6 months), there was room for flexibility in terms of how the matched pair spent their time and, therefore, the trial was pragmatic in its approach.

• The mixed-methods process evaluation provided useful insights into the perspectives of the participants and data on adherence, which could potentially inform changes to the intervention in a future study.

• The trial included an economic evaluation to assess the feasibility of data collection methods and some preliminary data on resource use.

Limitations of the study

• The study recruited only 40% of the target sample of people with ID, which suggests that recruitment is not feasible without changes to our approach.

• Some of the recruitment issues identified could be rectified through better planning in a full trial; for example, there were clearly issues relating to poor communication between the study team and the befriending services. We could have been more proactive in our engagement with the befriending services and made more sustained efforts to ensure that they understood and were in full agreement with the study design and randomisation process, rather than assuming that they were on board. They provided feedback indicating that they would have appreciated support with the recruitment of volunteers through events hosted by the study team, and this is another aspect that could be improved.

• We were unable to implement significant changes to the recruitment strategies owing to delays in the study being set up and our request for an extension to the study not being approved.

• We were unable to complete a 12-month follow-up because of delays in the set-up of the study. We therefore do not have data on adverse effects and unintended consequences beyond the 6-month period, including the impact of relationships ending on depressive symptoms and the well-being of participants. This information was not available at the 6-month follow-up as several of the pairs were planning to continue their relationship beyond 6 months.

• Proxy outcome measures (e.g. for depressive symptoms) were not used, and they may have been helpful, alongside the self-report measures, in establishing whether or not the intervention had positive outcomes. Some of the measures used in the study had a limited number of data on psychometric properties.

• We did not collect demographic data on car ownership and whether volunteers were working full time or part time, which might be helpful in understanding the characteristics of volunteers who are likely to take part in such a study.

• We could not mobilise PPI in the study as well as we intended.

Amendments to the logic model

Based on our experiences of conducting this study, we have proposed a few changes to the logic model (see Appendix 5). These include the need for additional inputs and resources, such as clear eligibility criteria and a comprehensive recruitment strategy in relation to people with ID, and the need for individuals with ID to have access to sufficient funds to be able to access activities in the community. Additional enablers include ensuring that carers are aware of the roles and responsibilities of volunteers, and the need for good communication between the befriending services, carers and volunteers to reduce the likelihood of potential conflict.

Implications and recommendations for future research

Although our results suggest that a fully powered RCT would not be feasible, it is possible to rectify these issues through alternative recruitment strategies, including recruiting participants through multiple NHS trusts and recruiting volunteers from multiple befriending services, or the provision of adequate resources to fund the intervention outside community befriending services. A future study should explore these alternative recruitment strategies.

There are challenges in conducting research with voluntary organisations as they often lack the necessary resources to recruit participants and implement the intervention, and researchers may have limited influence over these aspects of the research. Circumstances may also change during the course of the research project, owing to financial insecurity associated with external funding sources. The importance and value of collaborating with voluntary organisations in research should be encouraged.

Conducting research involving participants with depressive symptoms (many of whom had a clinical diagnosis of depression) proved to be challenging owing to difficulties in motivating depressed individuals to engage in novel activities. It is not clear whether the low recruitment rate was because the intervention was not acceptable to individuals with depressive symptoms or because the recruitment strategy was limited. This requires further exploration. For example, individuals with ID and depressive symptoms could be surveyed about whether or not they would be willing to engage in a befriending intervention. A future study on befriending in people with ID could have broader eligibility criteria and not be restricted to participants with depressive symptoms or other symptoms of mental ill health, and have a focus on evaluating whether or not it leads to improvements in well-being and social outcomes in the short and long term.

One of the issues elucidated by this study was the need for improved communication between all parties involved in the befriending relationship. Poor communication and misunderstandings between carers and volunteers led to relationships breaking down. It is paramount that all befriending services develop guidelines on how to work more effectively with carers.

Future research studies could also explore the use of peer support, which is defined as the mutual receiving and giving of emotional, social or practical support between individuals with shared lived experience. 78 It has been shown to have positive outcomes in studies of people with mental illness. 79 Although the use of a peer support model or a ‘buddy scheme’ in relation to people with ID has been used in a number of settings, research has been limited to only a few studies. One pilot study suggests that peer support may be useful in facilitating supported employment in young people with ID80 and another suggests that having a ‘buddy’ may help young people transition to a new school or college. 81 Peer support could be used more broadly to deliver changes in social outcomes and may be more acceptable to some individuals with ID, as they may find it easier to relate to peers than lay volunteers.

Future studies should give careful consideration to the design of the study, such as the use of non-randomised study designs in evaluating befriending. 37 For example, a prospective longitudinal study that involves the collection of data from a large number of services, and takes into account key confounders, could provide data on longer-term benefits.

A further recommendation is the need for effective involvement of patients and the public in the study design and in the recruitment of participants to identify and overcome key barriers to recruitment. Recruitment approaches could involve people with ID publicising the study (through the use of film clips and social media) and directly recruiting participants by explaining the study to their peers and describing personal experiences of befriending and how it has benefited them.

Conclusion

This pilot RCT of one-to-one befriending in people with ID and depressive symptoms failed to recruit a sufficient number of participants. Therefore, a future, larger-scale RCT is unlikely to be feasible unless there are substantial changes to the recruitment of participants with ID involving multicentre recruitment from NHS and social care services.

Contributions of authors

Afia Ali (https://orcid.org/0000-0002-0104-9370) (Associate Professor in Intellectual Disability Psychiatry) was the chief investigator and led the drafting of the final report. She is accountable for the integrity and accuracy of the report.

Emma Mckenzie (https://orcid.org/0000-0002-5213-2561) (Study Research Assistant) was involved in collecting the data and analysing the qualitative data. She contributed to the writing of the final report, particularly Chapter 4.

Zara Rasoul (https://orcid.org/0000-0001-9453-7906) (Honorary Research Assistant) was involved in analysing the qualitative data. She contributed to the writing of the final report, particularly Chapter 4.

Angela Hassiotis (https://orcid.org/0000-0002-9800-3909) (Professor of Intellectual Disability Psychiatry) made substantial contributions to the conceptualisation and design of the study, and contributed to the writing of the final report.

Stefan Priebe (https://orcid.org/0000-0001-9864-3394) (Professor of Social and Community Psychiatry) made substantial contributions to the conceptualisation and design of the study, and contributed to the writing of the final report.

Brynmor Lloyd-Evans (https://orcid.org/0000-0001-9866-788X) (Associate Professor in Mental Health and Social Care) made substantial contributions to the conceptualisation and design of the study, and contributed to the writing of the final report.

Rebecca Jones (https://orcid.org/0000-0001-6924-0924) (Clinical Research Fellow) analysed the results and contributed to the writing of the final report, particularly Chapters 3 and 5.

Monica Panca (https://orcid.org/0000-0002-4031-6478) (Research Associate) analysed the health economics data and contributed to the writing of the final report, particularly Chapter 3.

Rumana Omar (https://orcid.org/0000-0003-1483-1932) (Professor of Medical Statistics) was the lead statistician and supervised the statistical analysis of the results (Chapter 3).

Sally Finning (https://orcid.org/0000-0001-9934-7669) (Manager, Outward befriending service) made substantial contributions to the conceptualisation and design of the study and had oversight of the implementation of the intervention at the study site.

Shirley Moore (https://orcid.org/0000-0002-9658-7808) (Chief Executive of The Befriending Scheme) made substantial contributions to the conceptualisation and design of the study, and had oversight of the implementation of the intervention at the study site.

Christine Roe (https://orcid.org/0000-0002-6719-3279) (Volunteer Co-ordinator, The Befriending Scheme) facilitated the implementation of the intervention at the study site.

Michael King (https://orcid.org/0000-0003-4715-7171) (Professor of Primary Care Psychiatry and Trial Methodologist for Priment Clinical Trials Unit) made substantial contributions to the conceptualisation and design of the study, and contributed to the writing of the final report, particularly Chapter 5.

Publications

Ali A, Mckenzie E, Hassiotis A, Priebe S, Lloyd-Evans B, Omar R, et al. One-to-one befriending for people with intellectual disability and symptoms of depression: protocol for a pilot randomised controlled trial. BMJ Open 2020;10:e033989.

Tse CY, Mckenzie E, Hassiotis A, Ali, A. A survey of befriending services for people with intellectual disabilities in the United Kingdom [published online ahead of print 8 July 2021]. J Policy Pract Intellect Dis 2021.

Ali A, McKenzie E, Hassiotis A, Priebe S, Lloyd-Evans B, Jones R, et al. A pilot randomised controlled trial of befriending by volunteers in people with intellectual disability and depressive symptoms [published online ahead of print 27 September 2021]. J Intellect Dis Res 2021.

Data-sharing statement

The data are available upon request. Please contact the corresponding author.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health and Social Care.

Aim

The main aim of the economic evaluation was to determine the costs of delivering the befriending intervention and test the feasibility of collecting health-care resource use and health-related quality-of-life data to calculate the incremental mean cost per QALY gained of the befriending intervention compared with control (i.e. the cost-effectiveness) for a full RCT in people with ID.

Outcomes

• Health-related quality of life measured using the EQ-5D-Y and the EQ VAS questionnaire at baseline and at 6 months post randomisation.

• Health-care resource use recorded at baseline and at 6 months post randomisation.

The economic analysis was conducted from the primary perspectives of the NHS and personal social services. The horizon of the study is 6 months; therefore, discounting was not performed.

Methods

Results

Discussion

The results of our study show that the intervention has a 35% probability of being cost-effective. These results are conservative and should be interpreted with caution because of the small sample size and other issues that affected the study.

Data collection methods for a future economic evaluation were developed, and their feasibility was tested during this study. There was a good return of the resource use questionnaire from carers. Data on intervention costs were obtained from befriending services. Participants completed the EQ-5D-Y descriptive system and the EQ VAS, but there were important discrepancies between the scores, which could make the calculation of QALYs for a cost–utility analysis less reliable. The differences may have been due to a number of reasons, such as poor understanding of instructions on how to complete the EQ VAS or because the EQ-5D-Y is not an appropriate measure for adults with ID (it has not been validated for use in this group) and may not capture relevant aspects of health that are perceived to be important. In the absence of a validated measure of health-related quality of life in this population, perhaps the EQ-5D-Y should not be used in isolation to assess health-related quality-of-life outcomes in trials involving adults with ID, and should be used in conjunction with a proxy measure.

FIGURE 4.

Cost-effectiveness acceptability curve.

Changes in outcome scores

Jane had a baseline score of 18 on the GDS-LD and this decreased to 17 at her 6-month follow-up. There was a slight improvement in her self-esteem scores, which increased by 2 units, from 16 at baseline to 18 at follow-up. There was an improvement for scores on aloneness (7) and social dissatisfaction (8) at follow-up (total score of 15) compared with baseline scores (9 and 12, respectively; total score 21), but there was a reduction in the quality-of-life scores in the MANS-LD (63 at baseline and 54 at follow-up), and scores on the social support scale (SSSR) were largely unchanged.

Reflection

Jane’s history of depression and comorbid schizophrenia culminated in Jane lacking the desire and motivation to engage in activities. Jane’s relationship with Susan was successful because they shared common interests, such as an interest in animals, and Susan’s experience of previously working with individuals with ID and manging her mother’s mental health problems enabled her to understand and empathise with Jane. Susan described Jane as a ‘friend’, which was distinct from the relationship that Jane had with paid staff at her accommodation. Although befriending may be described as a ‘friendship-like relationship’, the fact that it is monitored by an external agency implies that there are certain distinctions, including safeguards to protect individuals (such as DBS checks, training and supervision) that would not occur in natural relationships. 36 Jane remarked that she thought that a duration of 6 months was too short for the intervention. In the context of this study, where there was a clear time-limited intervention, the nature of the befriending relationship is likely to have been constrained and, therefore, may not fully reflect how befriending would occur in practice, where pairs may continue to meet for many years, and the relationship may be unmonitored after a period of time.

Susan introduced Jane to her pet dog, which suggests that their relationship had relatively loose boundaries. This highlights the importance of differentiating befriending from the support that individuals may receive from support workers or paid staff, where the emphasis may be on the provision of practical support and there are stricter boundaries between staff and the individuals they support. Thus, although individuals with ID may be supported by informal and paid carers, the nature of the relationship with a befriender is different and, therefore, the befriender has the potential to make an important contribution to the person’s life. Indeed, Jane’s carer commented that Jane looked forward to her meetings with Susan as she was given undivided attention, which staff are often not able to provide.

Susan remarked that staff were sometimes ‘unhelpful’, which might suggest a lack of understanding from staff about the role of volunteers and how the volunteers’ roles may differ from their own. Similar findings have been described in other population groups and settings, and indicate the need for improved training and more collaborative working between staff and volunteers. 83

Jane was able to benefit from befriending by engaging in activities outside the home and particularly enjoyed going on walks with Susan’s dog. Susan also provided emotional support and assisted Jane to raise concerns about a member of staff who had been mistreating her, which may not have occurred if Susan had not encouraged her to talk openly about her concerns. Although Jane’s depressive symptoms did not appear to improve substantially from the befriending intervention based on self-report, information from the other sources appears to indicate that she did benefit from the relationship, which emphasises the need for more sensitive and valid outcome measures for people with ID and the importance of obtaining feedback based on both patient- and carer-reported outcomes.