针对有常见心理健康问题的囚犯在临近释放及释放后进行的一项复杂干预措施（Engager）评估：一项随机对照试验的研究方案
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.
作者信息
Kirkpatrick Tim, Lennox Charlotte, Taylor Rod, Anderson Rob, Maguire Michael, Haddad Mark, Michie Susan, Owens Christabel, Durcan Graham, Stirzaker Alex, Henley William, Stevenson Caroline, Carroll Lauren, Quinn Cath, Brand Sarah Louise, Harris Tirril, Stewart Amy, Todd Roxanne, Rybczynska-Bunt Sarah, Greer Rebecca, Pearson Mark, Shaw Jenny, Byng Richard
机构信息
Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth University, Plymouth, UK.
Division of Psychology and Mental Health, University of Manchester, Manchester, UK.
出版信息
BMJ Open. 2018 Feb 20;8(2):e017931. doi: 10.1136/bmjopen-2017-017931.
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.
引言
“衔接者”项目是一项“全程跟进”干预措施，旨在帮助有常见心理健康问题的囚犯从监狱过渡到社区。该试验将评估“衔接者”干预措施的临床效果和成本效益。
方法与分析
本研究为平行两组随机对照试验，以1:1的比例将个体分配至以下两组：（a）“衔接者”干预措施加标准护理（干预组）或（b）仅接受标准护理（对照组），试验在两个研究中心（英格兰西南部和西北部）进行。280名符合资格标准的囚犯将参与研究。“衔接者”是一项以人为本的综合干预措施，由从业者提供，旨在满足罪犯的心理健康和社会护理需求。它包括在囚犯出狱前及出狱后长达20周的一对一支持。主要结局是在出狱后6个月时通过常规评估结局量表（Clinical Outcomes in Routine Evaluation-Outcome Measure）测量的心理困扰变化。次要结局包括：在出狱后3个月、6个月和12个月时对主观需求满足/未满足情况、药物和酒精使用、健康相关生活质量和幸福相关生活质量的评估；在出狱后6个月和12个月时客观社会领域、药物和酒精依赖、服务利用及对服务感知帮助程度的变化，以及与停止犯罪相关的心理结构变化；出狱后12个月时的再犯罪情况。一项过程评估将评估干预措施实施的保真度，检验假设的作用机制并寻找意外后果。一项经济评估将估计成本效益。
伦理与传播
本研究已获得威尔士研究伦理委员会3（参考号：15/WA/0314）和国家罪犯管理服务局（参考号：2015 - 283）的批准。研究结果将通过论文和报告的形式传播给专员、临床医生和服务使用者。
试验注册号
ISRCTN11707331；预结果。
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