Article Text
Abstract
Introduction The ‘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 analysis The 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 dissemination This 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 number ISRCTN11707331; Pre-results.
- prison
- randomised controlled trial
- mental health
- resettlement
- protocol
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Footnotes
Contributors TK, CS and LC wrote the first draft of the manuscript. RB is the chief investigator on the National Institute for Health Research grant and RST, RA, MM, MH, SM, CO, GD, AS, WH, CQ, TH, MP and JS are co-applicants on the grant and contributed to the conceptualisation of the study design. CL, SLB, ASte, RT, SRB and RG are members of the study team that have contributed to the analysis of pilot data and development of the trial methodology. All authors provided critical evaluation of the manuscript and have given final approval of the manuscript.
Funding Engager is funded by the National Institute for Health Research (NIHR) under its Programme Grant for Applied Research Programme (grant number: RP-PG-1210-12011). This research was also supported by the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the National Health Service (NHS), NIHR or the Department of Health. The funder had no role in the design of this study and will not have any role during execution, analysis, interpretation of findings or decision to submit results. The views expressed are those of the authors and not necessarily those of NHS, NIHR or the Department of Health.
Competing interests None declared.
Patient consent Obtained.
Ethics approval NHS Research Ethics Committee (Wales REC 3, reference: 15/WA/0314).
Provenance and peer review Not commissioned; externally peer reviewed.