Title: A two-arm parallel group individually randomised Prison Pilot study of a male Remand Alcohol Intervention for Self-efficacy Enhancement: the APPRAISE study.
Funder: Chief Scientist Office, Scotland

Abstract: Aim: To undertake a two-arm, parallel group, individually randomised pilot study of a self-efficacy enhancing psychosocial alcohol intervention to reduce levels of alcohol consumption for males on remand in prison and on liberation. This will ultimately inform the operational progression criteria for undertaking a future definitive multi-centre, pragmatic, parallel group, Randomised Controlled Trial (RCT). Methods & design: The study will incorporate two phases aligned to the MRC’s framework for the development and evaluation of complex interventions (17). Phase I: two-arm, parallel group, individually randomised pilot study to examine recruitment, retention, contamination, follow-up rates, intervention booster sessions, measurement and variation in outcome measures, estimate possible effect sizes and explore other requirements of a future definitive multi-centre trial. Phase II: process evaluation with post-intervention interviews with a sub-group of trial participants and key stakeholders to elicit views on all aspects of the pilot RCT: context, delivery, receipt, implementation, sustainability; and facilitators and barriers to the intervention from their perspectives. An assessment of intervention costs and fidelity will also be undertaken. Study intervention: A psychosocial alcohol intervention to enhance self-efficacy (a main causal determinant of behaviour) with the aim of reducing alcohol intake in standard units of alcohol in the last 28 days, using the 28-day TLFB. In comparison to care as usual (control group), the intervention condition will comprise i) 1 x 40 min. face to face delivered in prison and 3 x 20 min. phone follow-up booster sessions at 3 days, 1 week and 3 weeks post liberation. The intervention will be delivered by organisations who currently deliver alcohol services at both prison study sites and on liberation. We have strong organisational support from prison and alcohol services. Setting and sample: A total of 180 adult males on remand for up to 3 months will be recruited from 2 purposively selected prisons (1 Scotland n=90; 1 North East England n=90). The proposed primary outcome measure for a future definitive study is total alcohol consumed in a 28-day period using the TLFB-28(40). Alcohol use frequency, quantity (on a typical occasion) and binge drinking will be assessed using the Alcohol Use Disorder Identification Test (AUDIT). The order of presentation of TLFB and AUDIT will be randomised in advance by a secure remote randomisation service. The Warwick-Edinburgh Mental Well-being scale (WEMWBS) will be used to assess mental well-being (41). Readiness to change will be measured using the Readiness to Change Ruler which measures readiness to change drinking behaviour (7). We will measure self-reported alcohol self-efficacy, using the Drinking Refusal Self-efficacy Questionnaire – revised (DRSEQ-R)(42) and alcohol expectancy, using the Negative Alcohol Expectancy Questionnaire (NAEQ) (43) intentions to drink alcohol with the item “How often do you intend to drink alcohol in the next 6 months?” on a scale of never to often (at least 4 or 5 times/week) adapted from existing scale (44) and alcohol-specific support (45). Furthermore, we will use the Euroqol EQ-5D -5L, which is a measure of health-related quality of life (46). We will use the economic form 90 to determine social costs (47). The results will be used to inform a future definitive multi-centre RCT.

Lay abstract: Background There are just under 94,000 people incarcerated in United Kingdom (UK) prisons (95% males) with many frequently suffering from multiple and complex health issues, including mental and physical health problems, learning difficulties and alcohol and drug misuse. Harmful alcohol use impacts significantly not only in relation to individual health, but also to the wider community and society. From our previous work we identified that 80% of participants we surveyed in prison have an alcohol use disorder (males on remand: 19% hazardous; 14% harmful; and 49% probably dependent). Alcohol-related crime costs £11 billion per year and as many as 70% of prisoners have admitted to being under the influence of alcohol when committing the crime which led to their imprisonment. Remand prisoners are those who are either unconvicted or convicted and unsentenced. Eleven percent of the prison population in England and Wales and 19% in Scotland are remand prisoners (18). This equated in 2015/2016 to around 7,500 males in England and Wales and approximately 1,400 in Scotland (18). Data shows that approximately 25% of individuals will not receive a custodial sentence (19). People spend on average ten weeks in custody whilst on remand (20). During this time, many do not have the opportunity to access mainstream prison health/public health services (21). We know that providing support and advice regarding alcohol consumption (often known as an ‘intervention’) can be effective in some groups of people. There is very little evidence regarding this for remand prisoners. However, there has recently been evidence in the UK that a short conversation about alcohol in probation settings can reduce re-offending. Addressing alcohol harm in prisons can be considered a ‘teachable moment’ where there is an opportunity for reflection, and the potential to reduce the risk of offending and costs to society, whilst helping to address health inequalities. Health savings of £4.3m and justice savings of £100m per year can be made as a result of appropriate alcohol interventions. Aims and methods We now wish to ‘test’ an alcohol intervention using a small sized ‘trial’. This is an experiment where males on remand will be split into two groups by chance. One group will be given the alcohol intervention whilst in prison and for a short time after they are released, the other group will not receive the intervention at all. This will help us find out if it is possible and acceptable to use these interventions and find out which one would work in the ‘real world’. We will also speak to people involved in the trial to find out what they thought. This small trial is often the best way to find out whether a new intervention will work before it can be tested in a larger trial and provided in the longer term. Patient and public involvement To find out the best way to carry out our trial, we have met with people who have been in prison and others who are involved in providing alcohol support and advice. They gave us advice and ideas of the best way to run our trial which we have used in the plan here. Sharing the results We will share the results of the trial with a range of people including, those who take part in the study, prison services (including healthcare), prison staff, through short reports, academic papers, meetings and social media.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL;STROKE