Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial

Abstract

IntroductionThe ‘Engager’ programme is a ‘through-the-gate’ intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention.Methods and analysisThe study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders’ mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness.Ethics and disseminationThis study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015–283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations.Trial registration numberISRCTN11707331; Pre-results.

Building programme theory to develop more adaptable and scalable complex interventions: Realist formative process evaluation prior to full trial

“…Although specifics of the ENGAGER intervention are used here to illustrate methodological points, we do not describe this complex intervention in detail. We refer interested readers to full descriptions of this intervention and its development (see Lennox et al, 2017;Pearson et al, 2015) prior to the full trial (Kirkpatrick, 2018). Offenders have high rates of mental health problems (Brooker et al, 2002;Grubin et al, 1997;Singleton et al, 1998), distrust, substance misuse, homelessness and relationship difficulties and high rates of comorbidity (Georgiadis et al, 2016), but poor continuity of service provision on release from prison (Byng et al, 2012;Williamson, 2006) and minimal access to mental health care (Forrester et al, 2013;Moore et al, 2015).…”

Individual health trainers to support health and well-being for people under community supervision in the criminal justice system: the STRENGTHEN pilot RCT

“…A clear starting point logic model of intervention components and aims underpins the intervention, based on the health trainer role in a previous trial of smoking cessation in disadvantaged groups 35 and the development of a collaborative care model for prison leavers with multiple health problems. 36 The health trainer role has been adapted for specific populations, including offenders 17 and smokers, 35 with early signs that the support is acceptable and feasible. However, further intervention development and piloting was required to integrate a focus on promoting mental well-being and multiple health behaviours and to understand the interactions between mental well-being and health behaviour changes.…”

“…The service had recently collaborated in extensive PPI activities for a trial of an intervention to support prison-leavers with common mental health problems to achieve their goals (ENGAGER 2). 36 The research team attended the regular Monday morning group session in order to provide service users with information about the STRENGTHEN pilot trial and invite them to an introductory session to help them decide if they would like to be involved in advising about the development of both the intervention and the trial. It was at this stage that service users advised the research team that, due to the potentially sensitive nature of the topic, there should be separate groups for men and women.…”

Engaging Without Exposing: Use of a Fictional Character to Facilitate Mental Health Talk in Focus Groups With Men Who Have Been Subject to the Criminal Justice System

“…In the United Kingdom, female prisoners are fewer in number, are housed in prisons further from their homes, and have very different resettlement needs. The ENGAGER research team plans to adapt the intervention for women in future, subject to trial results (Kirkpatrick et al, 2018). 3.…”

“…The aim of the ENGAGER project was to develop and evaluate a complex collaborative care intervention for men with common mental health problems, such as depression and anxiety, which would bridge their transition from prison to the community. 2 The intervention was specifically designed to break down service barriers, particularly between health and criminal justice sectors, and build constructive relationships between professionals and clients, thus providing a foundation for ongoing engagement with services (Kirkpatrick et al, 2018). The intervention development drew on a number of sources, including a realist review of the scientific and gray literatures (Pearson et al, 2015), a series of detailed case studies of current practice, the lived experience of a group of peer researchers, and a formative process evaluation embedded in a pilot trial.…”