A self-efficacy enhancement alcohol reduction intervention for men on-remand in prison: the APPRAISE feasibility pilot RCT

Article history

The research reported in this issue of the journal was funded by the PHR programme as award number 17/44/11. The contractual start date was in December 2018. The draft manuscript began editorial review in January 2023 and was accepted for publication in April 2024. 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’ manuscript and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this article.

Copyright statement

Copyright © 2024 Holloway et al. This work was produced by Holloway 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 adaptation 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.

2024 Holloway et al.

Prevalence of at-risk drinking in the United Kingdom criminal justice system

Hazardous drinking is defined as a repeated pattern of drinking that increases the risk of psychological or physical problems,2 whereas harmful drinking is defined by the presence of these problems. 3 Drinking at hazardous or harmful levels is categorised as risky or at-risk drinking.

The prevalence of at-risk drinking, which includes drinking at levels that harm a person’s health, is far higher amongst those in contact with the criminal justice system (73%). 4–9 In the UK, between 51% and 83% of incarcerated people are classified as risky drinkers. 10 For those on remand in prison, the prevalence is between 62% and 68%. 8 This compares to 35% in the general population. 11 Furthermore, rates of alcohol dependence among those who are incarcerated (43%) are 10 times higher than for the general population. 8

Interventions

Parts of this section have been reproduced from Newbury-Birch et al.,8 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text.

Alcohol brief interventions (ABIs) are a secondary prevention activity, which is aimed at people who are drinking in a pattern that is likely to be harmful to health and/or well-being. They have been frequently shown to be effective in primary health care,12,13 but they are typically delivered by practitioners who are not addiction specialists, to non-treatment, opportunistic populations. 14

ABIs largely consist of two different approaches: simple structured advice, which after screening raises awareness through provision of personalised feedback and advice on steps to reduce drinking behaviour and its adverse consequences; and an extended brief intervention, which generally involves behaviour-change counselling. Extended brief intervention introduces and evokes change by giving the participant the opportunity to explore their alcohol use, as well as their motivations and strategies for change. Both forms share the common aim of helping people to change drinking behaviour to promote health. 14

There is a wide variation in the duration and frequency of ABIs. However, typically they consist of between one and four sessions and are very short in nature (between 5 and 60 minutes). 15 They generally include personalised feedback on alcohol intake in relation to what the recommended limits are and discussion of both health and social risks, and may include setting personal targets which can include psychological and motivational interviewing. 15 One example of this is using the FRAMES (Feedback, Responsibility, Advice, Menus, Empathy, Self-efficacy) approach. 14

Due to the established links between risky drinking and crime and the costs to society, in both health and social care, it is important to find interventions that are effective. It has been shown that interventions that capitalise on the ‘teachable moment’ are conducive to behaviour change, for example where individuals consider their alcohol use within the context of their offending behaviour and its punitive consequences. 16,17

There is robust evidence from systematic reviews and meta-analyses to indicate that short alcohol interventions are effective in reducing alcohol consumption amongst risky drinkers in healthcare settings. 18,19 There is very little evidence of efficacy or effectiveness of alcohol interventions in reducing risky drinking amongst those in the criminal justice system, including the prison system, 20,21 and in particular remand prisoners. However, there has recently been evidence in the UK that alcohol (and drug) interventions can have an effect in reducing recidivism. 22 Furthermore, short alcohol interventions have been shown to reduce recidivism in the probation setting. 7 Nevertheless, there is limited evidence for the optimum timing of delivery, recommended length, content, implementation and economic benefit of an extended alcohol intervention in the prison setting. Likewise, there are weaknesses within the current evidence base with regard to the theoretical underpinnings of such interventions. This risks an intervention with a weak theoretical base and poorly specified ‘active’ ingredients, and which is less likely to deliver the desired outcomes.

Current evidence of alcohol interventions for those in the criminal justice system

A recent systematic review of the efficacy of psychosocial alcohol interventions for incarcerated people found that interventions in the prison setting have the potential to positively impact their relationship with and use of alcohol;21 however, because of small numbers and the use of different outcome measures it was not possible to conduct a meta-analysis or generalise findings. Notably, none of the studies focused on men on remand, as compared with other subgroups within prisons. Remand refers to those who are either unconvicted or convicted and unsentenced, held in custody awaiting trial and/or sentencing.

Rationale for APPRAISE

In 2021, 16% of the prison population in England and Wales, and 19% in Scotland, were remand prisoners. 23,24 This equated to around 12,750 in England and Wales and 1700 in Scotland. Approximately 25% of individuals will not receive a custodial sentence. 25 People spend on average 10 weeks in custody while on remand. 26 During this time, many do not have the opportunity to access mainstream prison health or public health services. 27

It has been shown that there is a complex interplay between individual and contextual factors and risky drinking behaviours and alcohol-related crime. 28 Addressing alcohol harm in prisons, at what can be considered a ‘teachable moment’, where there is an opportunity for people to reflect on their risky drinking and their current position, could potentially reduce the risk of re-offending and costs to society, and help to address health inequalities. 29 While there is an inevitable uncertainty in estimating the costs of alcohol-related crime and disorder, most estimates suggest they represent a considerable economic burden.

A recent Cabinet Office estimate reported that alcohol-related crime in England cost society £21.5 billion. 30 However, this estimate is outdated and there are concerns regarding the assumptions and methodological judgements used in deriving this estimate. 31 Better-quality estimates from four high-income countries placed the total costs of alcohol at 2.6% of gross domestic product (GDP) in 2007, of which 3.5% was made up of law-enforcement costs. 32,33 It has been shown that intervening to reduce alcohol use is cost-effective, generating both long- and short-term savings. Public Health England (PHE) estimated that every £1 invested in effective alcohol treatment brings a social return of £5. Evidence estimates that health savings of £4.3 m and crime savings of £100 m per year can be made as a result of appropriate alcohol interventions. 34 It has also been suggested that providing effective treatment is likely to significantly reduce the costs relating to alcohol as well as increase individual social welfare. 35

In 2017, the Scottish Parliament Health and Sports Committee held an inquiry into prisoner health care to consider how health and social care and medicines in prison are accessed and the effectiveness of health and social care in prison. The Inquiry report set out recommendations for the Scottish government to prepare a strategic plan to address prison social and health care. 36 Furthermore, National Institute for Health and Care Excellence (NICE) Guidelines [NG57]37 for people in prison acknowledge that adequate healthcare provision for prisoners would reduce pressure on community services later.

Theoretical background

The intervention in this study (the APPRAISE study) builds on previous research which has explored the theoretical validity of a self-efficacy-enhancing alcohol intervention,38,39 and was originally tested as part of a pilot cluster RCT in a general hospital setting with evidence of a potential effect. 38 In our recently completed Medical Research Council Public Health Intervention Development (MRC-PHIND) funded PRISM-A (Alcohol Brief Interventions for Male Remand Prisoners) study, we undertook development and refinement of this self-efficacy-enhancing alcohol intervention within the prison setting, working with men on remand to include a synthesis of their views, with reviews of the evidence base and theoretical underpinnings. 40

This current study worked solely with men on remand. We acknowledge that there are also women prisoners who have alcohol-use disorders. There is evidence that women face different issues when imprisoned, and different barriers to services, which are important to note. 41,42

The PRISM-A study with men on remand, carried out in two prisons in the UK, showed a high prevalence of risky drinking [82% scored more than 8 on the Alcohol Use Disorders Test (AUDIT)]. These numbers are comparable to other findings in the prison system in the UK,4–8 but more than three times as high as in primary care settings. 11 In the PRISM-A study, we were able to access, recruit, consent and identify those who were risky drinkers. We also found high levels of willingness of staff and participants to engage with the self-efficacy-enhancing intervention we tested for acceptability, and a willingness to participate in a trial that would involve follow-up at 6 and 12 months. Analysis of 24 in-depth interviews with male remand participants demonstrated strong substantiation that the intervention could help men on remand to develop skills and strategies that would be particularly useful on liberation. We also identified through the interviews a stronger preference amongst the participants for interventions of longer duration and that such interventions should incorporate a post-liberation component.

This is an under-researched area with large gaps in knowledge. A systematic review of alcohol interventions for offenders in the criminal justice setting identified a lack of evidence-based intervention strategies and highlighted the paucity of knowledge in this area, and in particular the lack of UK-based studies and the absence of rigorous studies focusing on men on remand. 8,21

Given the limited evidence on the effectiveness of psychosocial alcohol interventions for men on remand, we aimed to address this gap by carrying out a two-armed individually randomised pilot study to assess the feasibility and acceptability of a self-efficacy-enhancing intervention that had been developed during the PRISM-A study. 40 The results from this study will enable us to undertake a future definitive RCT evaluating its effectiveness and cost-effectiveness.

The study aligns to the MRC framework,43 using mixed methods with two linked phases conducted in two sites in the UK: Scotland and England.

Phase I involves a two-arm, parallel-group, individually randomised pilot study. The pilot evaluation provides data on feasibility and an assessment of the likely impact of the APPRAISE intervention to inform the feasibility of a future definitive multicentre RCT.

Phase II comprises a process evaluation. We have drawn on the MRC framework for process evaluation to guide the planning, design and proposed conduct of the process evaluation. 44 The aim of the process evaluation is threefold: first, to assess how the intervention was implemented, second, to undertake some preliminary exploration of change mechanisms underpinning the intervention and third, to assess the context within which the intervention is delivered.

An additional element was added to the study, as part of the study extension, during and in response to the COVID-19 pandemic. Following approval from National Institute for Health and Care Research (NIHR), we carried out a survey of prisons in Scotland, England and Wales to ascertain what alcohol services are available in male remand prisons and how coronavirus disease discovered in 2019 (COVID-19) has affected these services.

Study aims and objectives

APPRAISE comprised a two-arm, parallel-group, individually randomised, pilot study of a self-efficacy-enhancing psychosocial alcohol intervention for men on remand in prison. It aimed to provide the evidence to support the design of a future definitive multicentre RCT for which new funding would be sought. APPRAISE had the following objectives and questions.

Objective 1: to pilot the study measures and evaluation methods to assess the feasibility of conducting a future definitive multicentre, pragmatic, parallel-group RCT.

• Is it feasible to conduct a future multicentre RCT of a self-efficacy-enhancing psychosocial alcohol intervention for men on remand?

• Can we obtain reasonable estimates of the parameters necessary to inform the design and sample size calculation for a future definitive multicentre RCT? This includes standard deviations of potential continuous primary outcomes and estimates of recruitment, retention and follow-up rates.

• How well do participants complete the questionnaires necessary for a future definitive RCT?

• Can we collect economic data needed for a future definitive RCT?

• Can we access recidivism data from the Police National Computer (PNC) databases for trial participants?

• Can we access health data from routine NHS data sources for trial participants?

Objective 2: to assess intervention fidelity.

1. What proportion of the interventions are delivered as per protocol?

2. Is there any evidence of contamination between the two conditions and/or between those workers delivering the intervention.

3. To what extent was the intervention changing process variables consistent with the underpinning theory?

Objective 3: to qualitatively explore the feasibility and acceptability of a self-efficacy-enhancing psychosocial alcohol intervention and study measures to staff and for men on remand and on liberation.

1. How acceptable are the trial and intervention procedures (including context and any barriers and facilitators) to the following key stakeholders: men on remand in prison and on liberation; prison staff (including healthcare staff); commissioners; policy-makers and third-sector partners?

Objective 4: to assess whether operational progression criteria for conducting a future definitive RCT are met across trial arms and study sites and, if so, develop a protocol for a future definitive trial. Operational progression criteria are based on previous research results. 7

1. Do the two prisons invited to the study agree to take part?

2. Based on knowledge from previous data, do at least 90 eligible participants consent to take part and be randomised across the trial arms?

3. Do at least 70% of participants who consent to the trial receive the intervention?

4. Are at least 60% of those who received the intervention followed up at 12 months across trial arms and study sites?

Objective 5: to carry out a survey to ascertain what alcohol services are available in male remand prisons and how COVID-19 has affected services.

Structure of the report

The report comprises nine chapters, providing details of the background to the study, the rationale for the study, and an account of the research design, methods and findings. Reporting of public patient involvement (PPI) involvement and on equality diversity and inclusion is included. The report concludes by answering whether the study met its aims and objectives, learning from the study, strengths and limitations, while reflecting on the impact of COVID-19 and details of the recommendations for a future definitive trial.

This first chapter has provided the background research and rationale for the study and presented the study aims and objectives. Chapter 2 details the development of the intervention, presents the various elements of the intervention and theoretical underpinnings, and aligns itself to the Template for Intervention Description and Replication (TIDieR) framework. 45 delivery mechanisms as well as the logic model. Intervention training is also described. Chapter 3 reports the pilot trial methods including the management of the study, governance as well as ethics and research clearance. Chapter 4 presents the pilot trial findings, addressing Objectives 1 and 4. Chapter 5 reports the qualitative process evaluation methods. Chapter 6 presents the qualitative process evaluation findings, addressing Objectives 2 and 3. Chapter 7 details the results of the collection and access of economic data and recidivism data for trial participants, addressing Objective 1. Chapter 8 presents the APPRAISE COVID-19 survey methods and results. This was an additional piece of work we agreed with NIHR to carry out during COVID-19 and as part of the study extension period. Chapter 9 presents the discussion, PPI overview, strengths and limitations, recommendations for future RCT and conclusion. The aim of PPI was to provide meaningful engagement with stakeholders who had direct experience of the prison system, ranging from those who have experience of incarceration to those who run third-sector organisations supporting people on release from prison. Our PPI co-applicant was present to contribute in all PMG meetings. The Guidance for Reporting Instrument of Patients and the Public – short form (GRIPP2) form46 identifies the PPI study engagement (see Appendix 1). Finally, recommendations for a future definitive trial are presented. Due to COVID-19, we faced unavoidable modifications to the APPRAISE study. These are reported across chapters at the relevant points. To support completeness of reporting these unavoidable and important modifications to the trial due to COVID-19 (extenuating circumstances), we also completed the CONSERVE checklist9 (see Appendix 2).

Origins and development of the APPRAISE intervention

The APPRAISE intervention is an extended self-efficacy-enhancing alcohol intervention developed for men on remand with self-reported drinking that is harmful or hazardous. The APPRAISE intervention is based on previous ABI research focusing on self-efficacy as an appropriate basis for a single-session ABI intervention to enhance drinking refusal self-efficacy in a general hospital population. 38,39

From this original work, additional intervention modification was undertaken as part of the PRISM-A study on the basis of our learning from interviews with men on remand (n = 24). 40 The aim of these interviews was to explore the acceptability of a self-efficacy-enhancing ABI,40 including listening to feedback regarding the nine elements of the intervention: (1) preliminary discussion, (2) acquiring and providing information, (3) self-monitoring, (4) increasing awareness, (5) situation appraisal and appropriate coping strategies, (6) goal-setting, (7) relapse, (8) self-evaluation/self-reinforcement and (9) culmination. 39,40

The nine intervention elements of the single-session delivery were found to be acceptable to men on remand who were interviewed as part of the PRISM-A study. Feedback regarding frequency and intensity of contact identified a preference for more than one session, with a desire for additional sessions being delivered in the community following liberation. The participants reported that this would provide the opportunity to put the skills gained as a result of the single-session intervention into practice, once liberated, in real-world situations in which alcohol is widely available to them.

This evidence subsequently informed the development and refinement of the single-session ABI to an extended four-session ABI, incorporating a single session to be delivered in the prison setting with the remaining three additional booster sessions to be delivered following liberation.

APPRAISE intervention: theory, elements and logic model

The APPRAISE intervention is based on Social Cognitive Theory and designed to increase self-efficacy and other self-regulatory skills to reduce alcohol consumption. Figure 1 illustrates this process in the APPRAISE logic model. According to the theory, self-efficacy is a central determinant of health behaviour change. 47 Primary sources of self-efficacy that can be targeted through interventions are mastery experience, verbal persuasion, vicarious experience and physiological state. 39,40,47 All these sources of self-efficacy were addressed in the intervention (see Table 1 for all elements of the APPRAISE intervention). Mastery experiences should become more likely due to intervention elements addressing feedback, goal-setting, planning for release, including plans for coping responses, and self-monitoring of the intervention. Verbal persuasion was delivered by the interventionist, as were ways to achieve a calmer physiological state during high-risk situations. The intervention was designed to also increase outcome expectations by delivering arguments and elaborations and seeking social support. The intervention aimed to develop better self-regulation skills, thus enabling individuals to address their alcohol consumption behaviour. Liberation then offered participants the opportunity to implement and act on the targeted behaviours learned in the intervention in their ‘real life’ social context. The aim was for participants to have the ability to develop and build upon these skills and self-belief through success and mastery, with their efforts leading to the adoption and maintenance of reduced alcohol consumption. Reducing alcohol consumption can provide a sense of achievement and success, which should further increase self-efficacy. 39

FIGURE 1.

APPRAISE logic model.

The six proposed mechanisms of change in the logic model are: self-efficacy, outcome expectations, goals, plans, social support and high-risk situations.

1. Self-efficacy will be measured using: (i) an item on the Readiness to Change Ruler: ‘How confident are you that you could reduce (or stop) drinking when you are released?’ and separately (ii) the Drinking Refusal Self-efficacy Questionnaire.

2. Alcohol expectancy will be measured using the Negative Alcohol Expectancy Questionnaire.

3. Goals will be measured using an item on the Readiness to Change Ruler: ‘How much do you want to reduce (or stop) drinking when you are released?’

4. Plans will be measured using: (i) an item on the Readiness to Change Ruler: ‘How ready are you to reduce (or stop) drinking when you are released?’ and (ii) ‘I have made a detailed plan regarding when, where and how to reduce my drinking’.

5. Social support will be measured using the following items: (i) ‘The people who are important to me support me in reducing my drinking’ and (ii) ‘I have someone I can talk to about reducing my drinking’ in the Readiness to Change Ruler.

6. Barriers and high-risk situations will be measured using the following items: (i) ‘I know in which situations it will be difficult for me to reduce my drinking’ and separately (ii) the question ‘to what extent do you consider this to be a high-risk situation for you?’ in the Drinking Refusal Self-efficacy Questionnaire.

APPRAISE intervention materials

The APPRAISE intervention consisted of three documents:

1. APPRAISE Intervention Tool [V3_20October] (see Appendix 4)

2. Intervention Tool Postcard (Unit card) [V2_25Sept19] (see Appendix 5) and

3. Follow-up Manual [V1_25 Sept19] (see Appendix 6).

These documents together supported the delivery of the behaviour-change methods, linked directly to the determinants/mechanisms of change that focused on the targeted behaviour, in order to achieve the desired outcomes.

1. Document 1: the APPRAISE Intervention Tool was an eight-page, double-sided A5 booklet containing all nine Intervention Elements (Table 1: APPRAISE elements) and was the material used for the first intervention session.

2. Document 2: the Intervention Tool Postcard (Unit card) was postcard-sized and provided brief information about recommended drinking levels and units that was given to individuals to take away with them during Element 2 of the first intervention session.

3. Document 3: the Follow-up Manual was a six-page double-sided A5 booklet for use during all three post-liberation follow-up intervention sessions (Day 3, Day 7 and Day 21). The manual contained Element 1 as a way of re-establishing dialogue following on from the first intervention session, followed by Elements 5–9 of the APPRAISE intervention.

APPRAISE intervention procedures

The APPRAISE intervention was delivered in a safe, non-judgemental environment where engagement rules and trust were affirmed. This was with the aim of enabling and supporting the intervention activities. The APPRAISE Intervention Tool booklet contained ‘Things to remember’ – notes for the interventionist to support the delivery of the intervention elements. This reminded the interventionist of the key areas within each element to be emphasised during intervention delivery. It also provided a mechanism of supporting intervention fidelity in relation to delivery of the intervention changing process variables consistent with the underpinning theory.

While the APPRAISE intervention has specific core elements, the intervention itself was person-centred in that it became individualised during the course of the participant-interventionist conversation and subsequent intervention delivery.

The starting point for this approach was assessing participants’ readiness to change by way of completion of the Readiness to Change Ruler. 48 The scoring then provided information and understanding as to where the participant was in relation to their readiness to change. Similarly high-risk drinking situations were identified during Element 1 to provide further information that would build upon all the elements moving forward. This initial discussion was key to ensuring the interventionist was able to understand, recognise and respond effectively in relation to gauging how participants perceived their drinking and their motivation to change and how they used alcohol in their lives. Discussing answers to both the Readiness to Change Ruler and high-risk situations supported the delivery of an individual realistic starting point for both participant and interventionist. Depending on the results of these elements, each element could then be individualised to participants’ particular needs.

The participants AUDIT score, obtained following screening, was shared with them during Element 2 to feedback and provide information on recommended drinking levels, units and the impact alcohol may have been having on themselves, others and their life on the whole. Giving the Intervention Tool Postcard (Unit card) to the participant provided an easy-to-carry postcard-size information resource which could be studied following intervention sessions and post liberation.

In addition, the booklet had a perforated page that was removed at the end of Element 8 and was given to and kept by the individual receiving the intervention. The page was a takeaway ‘personal planner’ with reinforcement triggers of the key behaviour-change methods and mechanisms.

APPRAISE intervention training

Intervention training was provided at both study sites to members of the Change Grow Live (CGL) team who were supporting the delivery and which included those practitioners who would be delivering the APPRAISE intervention itself.

The aims of the training for interventionists were to:

• have an awareness and understanding of the APPRAISE intervention

• understand AUDIT Scores and what they mean

• have an awareness of the Readiness to Change Ruler and Risky Situation Assessments and why we use them

• be confident working with the APPRAISE booklet; and

• be able to deliver the APPRAISE intervention.

The training material ‘(APPRAISE training plan1_VG) (see Appendix 7) for the APPRAISE intervention provides interventionists with:

• a written brief on the theoretical underpinnings of the intervention

• paper copies of the three APPRAISE intervention documents

• paper copy of the APPRAISE elements

• online narrated review of the three APPRAISE intervention documents

• intervention delivery video

• paper copy of the AUDIT instrument; and

• opportunity to engage in intervention delivery role-play exercises.

On completion of the training, a six-question Likert scale survey (see Appendix 8) as a form of evaluation of the training undertaken was self-completed by interventionists and CGL team members from both study sites (see Intervention implementation).

APPRAISE intervention delivery mode and location

Following completion of baseline assessments and randomisation, those allocated to the intervention arm were invited to attend their first of three intervention sessions. This was delivered face to face by the identified interventionist at each study site. It was delivered in a quiet room either on the residential wing, a landing or in one of the CGL designated rooms and was delivered at both sites by CGL interventionists. Four members of the CGL team from the England study site and two members from the Scotland study site attended the intervention delivery training.

At the beginning of data collection, both study sites had allocated two interventionists. Due to resource capacity and sick leave during the data-collection period, Scotland had one interventionist and England had two interventionists able to deliver the interventions.

We asked the three interventionists for details of their education and previous training experience. This request was made during COVID-19 when we were only able to communicate via e-mail. While there was a willingness to provide the information, due to the incapacity of interventionists to find the time we were unable to obtain that information.

The APPRAISE intervention comprises nine elements (Table 2) to be delivered in four steps: Step 1 comprises a 1 × 40-minute face-to-face session in which the nine elements are covered and delivered by a trained practitioner from CGL in the prison setting. Steps 2, 3 and 4 are 20-minute sessions conducted by phone, on or close to day 3, 7 and 21 post liberation. The post-liberation sessions include elements 1 (preliminary discussion), 5 (situation appraisal), 6 (goal-setting), 7 (relapse), 8 (self-evaluation/self-reinforcement) and 9 (culmination). Table 3 provides details of the intervention sessions, duration, intensity and dose.

APPRAISE post-liberation intervention modifications due to coronavirus disease discovered in 2019

The outbreak of the COVID-19 pandemic had a significant impact on the project. Due to COVID-19 restrictions, access to both study sites for the RAs and research team was halted. It became clear quite quickly that the impact of the pandemic resulted in there being limited or no capacity for the interventionists to follow up on liberation data of those in the intervention group or deliver post-liberation intervention. Prison staff were also unable to provide us with liberation data, as their focus was rightly on the COVID-19 response in prisons. Similarly, RAs were unable to go into the prisons and access liberation data.

Modifications on timing of the post-liberation intervention delivery were made in an attempt to provide flexibility, if there was an opportunity to deliver the post-release interventions. This meant that post-release intervention sessions could still be attempted where possible with the originally intended interval between them maintained to the extent possible (4 days between sessions 2 and 3, and 14 days between sessions 3 and 4).

Setting and site selection

The study occurred in two study sites hosting men on remand within the prison estate of the Scottish Prison Service (SPS) and His Majesty’s Prison and Probation Service (HMPPS), one in Scotland and one in England respectively.

The complexity of the prison estate cannot be overestimated. Our learning from previous work had highlighted how essential it was to engage with our colleagues within the prison system with regard to the study. Prison governors and associated personnel at both prison sites were involved in discussions regarding the study while we were developing the initial funding application. We had built good operational knowledge as well as relationships with key personnel over the course of securing funding.

The prison governor at each site was the primary gatekeeper and contact for the study team. This proved vital in previous prison research work and again for this study. In the months leading up to data collection commencing, while waiting for ethics approval, we had several meetings with the governors at both study sites and also with appointed research study contacts for day-to-day operations. Visits were made to both prison sites to share details of the study with prison officers, health professionals and CGL over several months. The strong relationships formed were essential to our understanding of the complexities of the prison estates and the day-to-day work carried out there, providing insight into how we could undertake the research study with minimal disruption to the estate operations.

Eligibility criteria

Men detained on remand had to meet the following criteria:

• Inclusion criteria

  • detained in either the SPS Scottish study site or His Majesty’s Prison Service (HMPS) North East England study site

  • have been in the prison setting for 3 months or less

  • aged 18 years and over

  • informed consent given

  • ≥ 8 on the AUDIT screening tool51

• Exclusion criteria

  • previously recruited to the study

  • unable to give informed consent or deemed incompetent/unable to make an informed decision regarding consent

  • identified as a risk to self and/or others by prison staff

  • judged to be under the influence of an illicit substance by prison or research staff

  • currently taking Antabuse

  • on a segregative rule under the prison rules

  • not able to understand the documents, which are in the English language, or agree to the research assistant (RA) working with them to understand them.

Prison and/or research staff were responsible for making a subjective judgement as to whether or not a remand person was under the influence of an illicit substance and whether the level of intoxication was likely to have an influence on risk or capacity to understand/consent.

Participant selection and recruitment

The prison staff were key to facilitating the selection and recruitment of study participants at both sites. At the England study site, peer induction workers were also key to this process. The RAs spent time developing good working relationships with prison staff and peer induction workers on the wing. Information regarding males on remand entering the estate was made available to the RA with the selection and recruitment process across both study sites, as outlined in Table 4.

Consent

The RA at each site reviewed the Participant Information Sheet (PIS) with men on remand who met the eligibility criteria, provided a written and verbal description of the study, answered any questions or queries and then invited them to consider participating. The RA obtained informed consent from those willing to participate. Those who did not wish to participate at this point were thanked for their time and received no further interaction with regard to participating in the study.

We were aware that freedom of consent can easily be undermined for prisoners and those in the criminal justice system, which means these individuals may be more vulnerable to exploitation or abuse by researchers: learning disabilities, illiteracy and language barriers are prevalent within these populations. The prevalence of these characteristics alongside the power differential between researcher and potential participant meant that particular care was needed to ensure that valid, freely given and fully informed consent was achieved. For the purposes of this research, we considered valid consent as underpinned by adequate information being provided to the potential study participants and that they had the capacity to decide for themselves. A capable person would:

• understand the purpose and nature of the research

• understand what the research involves, its benefits (or lack of benefits), risks and burdens

• understand the alternatives to taking part

• be able to retain the information long enough to make an effective decision

• be able to make a free choice; and

• be capable of making this particular decision at the time it needs to be made.

Participants were asked to consent to their data being used for the present study as well as consenting to long-term follow-up (beyond this study) and for appropriate linkage to be conducted.

Stopping rule/discontinuation/withdrawal criteria

Participants were reminded during the trial that they were free to withdraw at any time without having to give a reason and without it affecting their care in the prison setting or on liberation. Where a participant wished to withdraw, we honoured their wish. We also made attempts to ascertain and document the reason for withdrawal, recording this within the case report form (CRF). Participants who requested withdrawal from the study intervention were asked if they would be willing to remain in the study for the purposes of follow-up data collection. Data provided at the point of withdrawal were retained and used in the study analysis, where the patient consented to this.

Potential reasons for participants being withdrawn from the study were: participant withdrawal of consent; RA discretion in the best interest of the participant to withdraw; the RA was informed by Prison, NHS or service staff that it was in the best interests of the participant to withdraw; an adverse event required discontinuation of participation in the trial; or termination of the trial by the sponsor.

Sample size

The aim was to recruit at least 180 participants in total comprising 90 participants per study arm across the two study sites. From prison data obtained from correspondence with SPS and the Ministry of Justice (MoJ), we had estimated that approximately 50% of participants would be liberated while the rest would remain incarcerated, leaving 45 participants per study arm (90 in total) across the two study sites.

The target sample size

1. would enable us to calculate two-sided 95% confidence intervals around proportions recruited, liberated, and dropping out in each study arm with half-widths of < 0.15

2. exceeds the 30 per group recommendation of Lancaster et al.,53 and the 35 participants per group recommendation of Teare et al.,54 for estimating key unknown design parameters, for example standard deviation with sufficient precision when the primary outcome is continuous; and

3. would ensure that within each study arm within each site we were satisfying the minimum 12 per group rule of thumb of Julious for pilot trials. 55

Participant screening

The AUDIT tool51 is considered the ‘gold standard’ alcohol screening instrument and was developed by the World Health Organization (WHO). It is a 10-item screening tool designed to assess alcohol consumption, drinking behaviours and alcohol-related harms. The score is the total sum derived from the 10 questions. Scores range from 0 to 40. A score of 8–15 indicates hazardous/increasing-risk alcohol use, 16–19 indicates harmful/high-risk alcohol use and 20–40 indicates likely dependence. The AUDIT has been used previously in the criminal justice system,7 and was found to be feasible and acceptable with men on remand in the PRISM-A study. 40

After obtaining informed consent, the RAs screened all study participants using the AUDIT. Those with a score of ≥ 8 were considered eligible for the study. Those scoring < 8 on AUDIT were thanked for their time and took no further part in the study. Those with an AUDIT score of ≥ 8 completed the baseline assessment and measures and were then randomised.

Randomisation and blinding

The randomisation process was supported by the Edinburgh Clinical Trials Unit (ECTU). Due to the restriction of the use of electronic equipment and no access to mobile phones by the research team and RAs while in the prison setting, we were unable to use a randomisation system, such as an interactive voice response telephone system or one accessed over the web. Allocation was conducted at the level of the participants, randomised to the active or control intervention using stratified block randomisation by site, via opaque sealed envelopes, based on a predetermined random number allocation carried out by the ECTU. Allocation was conducted by researchers opening the next sequential sealed opaque envelope after consent had been provided and the baseline assessment completed. Therefore, RAs were blind to group allocation at baseline.

The RAs were not involved in the delivery of the active and control interventions but were aware of study allocation of participants as the trial progressed. Allocation concealment was used whereby neither the person delivering the interventions nor the participant was aware of the study allocation until they were irrevocably entered into the trial. Both the trial statistician (RP) and health economists (AS, JB) were blind to group allocation prior to the final analysis and only had details of study participants by study number.

The trial statistician and health economists were only to be unblinded if requested to do so by the Data Monitoring and Ethics Committee Project Steering Group (DMEC), due to safety concerns. This was not necessary during the study and unblinding took place at the final analysis stage.

Self-report primary outcome measure

The proposed primary outcome measure for a future definitive study was total alcohol consumed (in units) in a 28-day period. This can be ascertained using the 28-day timeline followback questionnaire (TLFB-28). 43 Three other variables can be derived from the data: per cent days abstinent, drinks per drinking day (secondary outcome measures) and total number of days where alcoholic drinks are consumed. The TLFB-28 was to be conducted by the RA at time points (TP) 1 and 2.

Self-report secondary outcome measures

Secondary outcomes measures were to be completed at TP0 (baseline), TP1 (6 months) and TP2 (12 months).

Alcohol use frequency, quantity (on a typical occasion) and binge drinking were assessed using the AUDIT. 34 In order to assess the utility of using Average Drinks per Day derived from the AUDIT at 12 months as a primary outcome measure we planned to randomise the order of presentation of TLFB-28 and AUDIT and conduct a levels-of-agreement analysis, using TLFB-28 as a gold standard, to explore whether AUDIT is an acceptable proxy for TLFB-28. The order of presentation of TLFB and AUDIT was to be randomised in advance by a secure remote randomisation service. (See section ‘Follow-up plans post-COVID 19’ for changes to the use of AUDIT and TLFB-28 at TP1 and TP2.)

The following study measures were to be used across the three time points.

Baseline data collection and assessment of outcomes

Baseline data (TP0) collection was conducted prior to randomisation to prevent observer or respondent bias to questions asked or answered at baseline by knowledge of the randomisation group, with follow-up data collected at TP1 (6 months) and TP2 (12 months).

The baseline assessment data were collected via researcher-led completion of hard-copy questionnaires embedded within the Baseline CRF (TP0). Due to restrictions on the use of electronic equipment in the prison estate, we were unable to use electronic devices to record study data on site. The RA was able to answer any questions and offered clarification as needed. The baseline assessment took approximately 35 to 60 minutes. Participants also completed the Participant Locator Form (see Appendix 10). The Locator Form was used to collect information from participants about a range of methods, modes and formats of contacting them at follow-up if they were liberated. Immediately after, participants were randomised, informed of their allocation,61 and thanked for their time.

The baseline CRF recorded demographic data on age, known court dates, ethnicity, postcode [Scottish Index of Multiple Deprivation (SIMD)], relationship status, and educational achievement. In addition, baseline data on proposed secondary outcome measures were recorded via the Readiness to Change Ruler,10 the EQ-5D-5L,59 the Warwick-Edinburgh Mental Well-being Scale,56 the Drinking Refusal Self-efficacy Questionnaire – revised,57 the Negative Alcohol Expectancy Questionnaire,58 and a revised version of the Economic Form 90,60 which recorded data relating to hospital and or A/E visits, general practitioner (GP) registration and visits, engagement with Community Psychiatric Nurse, engagement with any addiction services, emergency ambulance use, engagement with social worker, current living arrangements, ever been homeless, employment status, number of arrests and number of court visits.

Control condition (care as usual)

The control condition (care as usual) consisted of similar components at both study sites.

Intervention condition

Following completion of baseline assessments and randomisation, those allocated to the intervention arm were invited to attend their first of three intervention sessions. This was delivered face to face by the identified interventionist at each study site. The APPRAISE intervention was delivered at both sites by CGL.

The in-prison and post-liberation elements of the APPRAISE intervention are described in full detail in Chapter 2.

Follow-up data collection

We worked with our PPI co-applicant and former community justice mentor, who mentored men in prison and on liberation, to advise on the strategies to maximise retention and follow-up. These strategies were based on her own experiences of following up her mentees on liberation and were also strategies used by CGL community justice workers. Each study participant provided their preferred method of follow-up by completing the Locator Form at baseline.

Follow-up assessments were to be attempted at 6 months (TP1) and 12 months (TP2) post-randomisation where the participant had been (a) not liberated, (b) liberated and in the community, or (c) liberated and then re-incarcerated. An 8-week window was in place for the follow-up to be completed for both of the time points. If a participant was not contacted at 6 months they were still approached again at 12 months. Follow-up was to be conducted by the RA at each study site. However, due to changes in personnel at both study sites during the study, all follow-ups for both study sites were not conducted by the RA who undertook recruitment and baseline measurements. Feedback from all RAs noted that participants responded to follow-up more positively when it was the RA they knew and remembered from recruitment and baseline. There was a sense of trust that had been built which was less evident when the new RAs were undertaking the follow-ups.

Statistical methods/analysis plan

The progress of participants through the APPRAISE pilot trial is presented in accordance with CONSORT  (Consolidated Standards of Reporting Trials) guidelines40 to allow descriptions of key parameters required for a future RCT: eligibility rates, consent, adherence, retention at follow-up and data completeness of outcome measures.

Ethics approval

Ethics approval for the study was sought and secured from five different organisations:

1. Integrated Research Application System (IRAS) (East of Scotland Research Ethics Service) REC reference 19/ES/0068, IRAS project ID 261003

2. HMPPS Ministry of Justice, National Research Committee reference 2019240

3. SPS Research Access and Ethics Committee (RAEC) approval letter dated 13 June 2019

4. the University of Scotland School of Health in Social Science Nursing Studies Research Panel approval letter dated 26 September 2019

5. NHS R&D in Scotland (R&D No. 2019/0268).

The University of Edinburgh acted as trial sponsor (CAHSS 18/2/02). A model non-commercial agreement (mNCA) was in place for the England study site but not for the Scotland study site following discussions with Health Research Authority (HRA). The mNCA is strongly recommended as the agreement between sites for clinical trials/investigations; it is not mandatory for a non-commercial study. For the Scotland study site it was not considered the appropriate mechanism for agreement and therefore a site agreement between the Sponsor and the SPS site was drawn up and put in place. The agreement for this took many months of discussion with stakeholders and was a long protracted process causing delays to the start of recruitment at the Scotland study site.

Management of the study

Two groups were in place to support the research management of the study. The PMG was convened and comprised the chief investigator (CI), co-applicants, our PPI member who was also a co-applicant, the Project Manager and researchers from both study sites working on the project. Professor Jeremy Bray chaired the PMG. The frequency of the PMG meetings was determined by the needs of the project. The PMG’s responsibility was to ensure appropriate and timely study implementation. The constitution and composition of the PMG and TSC were in line with NIHR research governance guidelines.

The TSC was appointed to provide independent assessment of the study progress, adherence to the protocol, patient safety and well-being of study participants, consideration of new information of relevance to the progress of the study and support of decision-making on the merits of a future definitive trial. A subcommittee DMEC was also convened following approval from NIHR-PH as this was a pilot feasibility study. It was agreed that because the study was a feasibility study rather that a definitive trial, it was sufficient to have the group as a subcommittee rather than having it sealed off as a separate entity. The terms of reference (ToR) for the TSC with the ToR for the subcommittee added were agreed (see Appendix 11).

Changes to the original study protocol

During the course of the study, a number of amendments were made to the study protocol, the majority as a result of the impact of the COVID-19 pandemic. Several of these changes have been discussed above, but this section provides a comprehensive catalogue of substantial changes. All proposed amendments to the study were discussed by the CI, PMG and TSC. Once agreed, the process involved discussion with the study sponsor, whose responsibility it was to determine if an amendment was substantial or not.

Substantial amendments were submitted to the East of Scotland Research Ethics Service Committee by the CI, on behalf of the sponsor. Once approval was obtained, changes to the study protocol were then implemented. (Table 6 provides details of the substantial protocol changes approved and made.)

Overall study recruitment

Both study sites agreed to take part with the necessary organisation approvals and ethics approvals were secured. Recruitment opened at the England site on 2 December 2019 and closed on 28 February 2020, as the required sample size of 90 participants had been met. The Scotland site opened to recruitment on 15 January 2020 and was halted due to COVID-19 restrictions on 13 March 2020, with 42 individuals recruited to the study. Following discussions with the site governor and the head of research at the Scottish Prison Service, HMP Scotland was closed to any further recruitment on 12 June 2020. Differences in start date between study sites were due to difficulties caused by the model non-commercial agreement (mNCA) requested by the Health Research Authority (see Ethics approval).

Table 7 provides an overview of the screening and recruitment data at the two sites.

Recruitment methods varied between the two sites as the prison profiles, regimes and access were different. As such, the screening and recruitment data for the two sites are considered in more detail separately.

England study site recruitment

Table 8 summarises the screening and recruitment data for England by week number. Unlike the Scotland site, where all individuals on remand were given an information sheet about the trial, not all of the individuals entering HMP England received an information sheet.

The number of prisoners on remand at the start of recruitment was not provided by the England site. Reasons why individuals were excluded in England are summarised in Table 9.

Scotland study site recruitment

Table 10 contains information on the number of individuals entering HMP Scotland on remand by week of recruitment. At the start of recruitment, there were 162 prisoners on remand, and an additional 159 individuals entered the prison on remand during the data-collection period. During recruitment, 195 individuals were excluded, and 86 were not approached due to lack of resources and time.

Table 11 provides information on the number of screened individuals with 0, 1, 2, 3 or 4 reasons for being excluded from the study.

Of those who had at least one reason for being excluded at the Scotland site, there was a total of 210 exclusion reasons, and these have been summarised in Table 12. Of note is the largest exclusion reason, which was being on remand for more than 3 months. Being liberated (n = 49) and operational reasons (n = 44) were the second and third most prevalent reasons for exclusion respectively.

We had not created a standard proforma of consistent categories for exclusion, which resulted in different terminology being used for the exclusion criteria at the two study sites. We also noted that some criteria were much more frequent at one study site compared to the other (there was not much consistency between sites). Following several discussions by the PMG we agreed, for the purposes of the pilot trial and to support our understanding of these differences, that for a future trial we would continue the site-specific reasons and as such the exclusions are reported separately.

Consented and randomised

There were 134 participants who gave informed consent (90 from the England site and 44 from Scotland). A total number of 132 participants were randomised. Two participants from the Scotland site who were consented did not proceed to randomisation. One participant was considered to have lacked capacity and the other scored less than 8 on the AUDIT. Table 13 provides data on the numbers randomised to the intervention and control arms at each study site.

Randomisation recruitment rates

It was anticipated that recruitment would start on the 1 September 2019 and would last for 4–6 months, with recruitment being quicker in England compared to Scotland. We were predicting this based on our learning from the PRISM-A study. 40 Variations in the speed of recruitment can partially be explained by access opportunities. Due to the different regimes within the prisons, the amount of time on the halls was less in Scotland than in England. The regimes also impacted on the amount of time the researchers were able to be on site. For example, in England the researcher was on site 5 days a week. In Scotland the researcher was on site 3 days a week.

Table 14 contains information on the number of participants randomised by month and by site, with Figure 2 providing a graphical overview of the recruitment rate by site and as a total. The planned rate of recruitment starts from 2 December in Figure 3 to correspond with when the England site was opened to recruitment.

FIGURE 2.

Consolidated Standards of Reporting Trials 2010 flow diagram.

FIGURE 3.

Recruitment graph of planned recruitment and overall recruitment by study site.

Baseline characteristics

The demographic characteristics of the randomised participants can be found in Tables 15 and 16. The average age of the participants was 34 years (median 31, SD 10), the majority of participants were single [87 (66%)] and considered themselves to be White British or White Scottish. Regarding highest educational achievement, 36% had no formal qualifications, 19% had a recognised trade apprenticeship, 39% had GCSEs or equivalent, 1% had A-levels or equivalent, while 6% were educated to university or college degree level. There was substantial variability in terms of the number of drinks consumed per month at baseline: the SD was 73 (range 5–198 drinks per month). The median number of drinks consumed per month was 80 (mean 94). The mean total score of the AUDIT-C was 9.2 (SD 2.2, range 3 to 12). A total score of < 5 on the AUDIT-C is regarded as low risk, while a score of 5 or more indicates hazardous drinking. Overall, 98% of participants were in the ‘at-risk’ category for drinking based on the AUDIT-C (≥ 5) at baseline, including 23% who recorded the maximum value of 12 on the AUDIT-C (indicating extremely high levels of drinking). Only two participants were considered to be at low risk (2%). These two participants had an AUDIT-C of 9 and were therefore eligible for the study.

On average, high scores were recorded on the readiness to change ruler at baseline except for the item ‘I have made a detailed plan regarding when, where and how to reduce my drinking’, indicating that most participants had not made a detailed plan regarding when, where and how to reduce their drinking. The EQ-5D item scores suggested that participants had moderate problems with anxiety/depression on average; all other EQ-5D item scores were low on average. The WEMWBS had a mean of 38.5 (SD 12.4), indicating probable clinical depression in most participants.

Figure 4 shows side-by-side boxplots of the ages of participants in each site.

FIGURE 4.

Ages of participants at HMP England and HMP Scotland.

In-prison and post-liberation intervention delivery

Table 17 contains information on whether those randomised to the intervention arm received the in-prison and post-liberation intervention sessions. Out of 68 participants randomised to the intervention condition, 53 received the in-prison intervention session (77.9%, 95% CI 66.2% to 87.1%). This percentage is greater than the 70% threshold specified as one of the criteria necessary for progression to a future larger randomised controlled trial (Objective 4c).

Reasons for why the in-prison intervention was not delivered are shown in Table 18.

Only one ‘day-3 post-prison intervention’ session was attempted and was delivered (duration 30 minutes) at the Scotland site. No ‘day-7 post-prison intervention’ sessions were attempted. Only one ‘day-21 post-prison intervention’ session was attempted and was delivered to one participant (duration 30 minutes) at the England site.

The main reasons why participants did not receive the post-prison interventions were (1) they could not be contacted and (2) CGL staff were unable to contact participants due to the impact of the COVID-19 pandemic.

Data for the duration (minutes) of the intervention sessions across both study sites are presented for all but one of the 53 interventions delivered in Table 19. There was a marked difference in the median time taken to deliver the intervention between the two sites: the intervention duration was half an hour in England compared to 1 hour in Scotland. The shortest time for an intervention was only 5 minutes in England, whereas in Scotland it was 30 minutes. The maximum time for delivery was more aligned across sites, being 70 minutes and 80 minutes in England and Scotland, respectively.

Follow-up and withdrawal

There were no formal withdrawals from the study. However, only 3 out of 132 randomised participants recorded any follow-up data at 6 months (2.3%, 95% CI 0.5% to 6.5%), and only 18 out of 132 randomised participants recorded any follow-up data at 12 months (13.6%, 95% CI 8.3% to 20.7%) (Table 20). The low numbers of follow-ups were due to the impact of COVID-19.

Tables 21 and 22 show the numbers of follow-ups at 6 and 12 months respectively within each site and randomised allocation group.

Out of the 44 participants receiving the intervention, only 13% were followed up to 12 months. Note that this percentage is much lower than our progression criteria (Objective 4d) specifying that at least 60% of those who received the intervention should be followed up at 12 months across trial arms and study sites. This progression criterion was set prior to the COVID-19 pandemic.

The greatest increase in numbers of those followed up at 12 months was seen at the Scotland site, where we were able to have some access to the prison site and identify where participants were located; however, this was minimal. In England where there was no access to the estate this meant at the time of intervention delivery and follow-ups we did not know who had been liberated and who had not liberated. However, this access remained very limited. Reasons for being unable to follow up at 12 months are shown in Table 23. Out of all 132 randomised participants, 53 (40%) were not liberated or released at 12 months follow-up, 47 (36%) were uncontactable and 14 (11%) could not be located even though they had been released.

Data completeness

Table 24 contains information on data completeness at baseline and follow-up for all 132 randomised participants. Complete data collection refers to when a participant has recorded data for all relevant questionnaires and outcomes. Incomplete data collection refers to when the participants have recorded data on the primary outcome, but have not recorded data for one or more secondary outcomes.

The information we have collected on data completeness helps us to address Objective 1c (‘How well do participants complete the questionnaires necessary for a future definitive RCT?’). The majority of participants did not complete questionnaires, which was at least partly due to the difficulties in following up participants because of the COVID-19 pandemic and lockdown restrictions. However, considering the small numbers of participants who did complete the questionnaires, nearly half of them (9/21) could not (or would not) complete all the questionnaires or record data in response to every question.

Outcomes