Gilchrist Gail, Landau Sabine, Radcliffe Polly, McMurran Mary, Feder Gene, Easton Caroline, Parrott Steve, Kirkpatrick Sara, Henderson Juliet, Potts Laura, Stephens-Lewis Danielle, Johnson Amy, Love Beverly, Halliwell Gemma, Dheensa Sandi, Berbary Cassandra, Li Jinshuo, Strang John, Gilchrist Elizabeth
1National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 4 Windsor Walk, London, SE5 8BB UK.
2Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF UK.
Pilot Feasibility Stud. 2020 May 11;6:62. doi: 10.1186/s40814-020-00580-7. eCollection 2020.
Strong evidence exists that substance use is a contributory risk factor for intimate partner abuse (IPA) perpetration. Men in substance use treatment are more likely to perpetrate IPA than men from the general population. Despite this, referral pathways are lacking for this group. This trial will assess the feasibility of conducting an evaluation trial of a tailored integrated intervention to address substance use and IPA perpetration to men in substance use treatment.
METHODS/DESIGN: ADVANCE is a multicentre, parallel-group individually randomised controlled feasibility trial, with a nested formative evaluation, comparing an integrated intervention to reduce IPA + substance use treatment as usual (TAU) to TAU only. One hundred and eight men who have perpetrated IPA in the past 12 months from community substance use treatment in London, the West Midlands, and the South West will be recruited. ADVANCE is a manualised intervention comprising 2-4 individual sessions (2 compulsory) with a keyworker to set goals, develop a personal safety plan and increase motivation and readiness, followed by a 12-session weekly group intervention delivered in substance use services. Men will be randomly allocated (ratio 1:1) to receive the ADVANCE intervention + TAU or TAU only. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Regular case management meetings between substance use and ISS will manage risk. Outcome measures will be obtained at the end of the intervention (approximately 4 months post-randomisation) for all male and female participants. The main objective of this feasibility trial is to estimate parameters required for planning a definitive trial including rates of consent, recruitment, and follow-up by site and group allocation. Nested formative evaluation including focus groups and in-depth interviews will explore the intervention's acceptability to participants, group facilitators, keyworkers and ISS workers. Secondary outcomes include substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts, and quality of life.
Findings from this feasibility trial will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE intervention for reducing IPA and improving the well-being of female (ex)partners.
ISRCTN79435190.
有充分证据表明,物质使用是亲密伴侣虐待(IPA)行为的一个促成风险因素。接受物质使用治疗的男性比普通人群中的男性更有可能实施亲密伴侣虐待行为。尽管如此,针对这一群体的转诊途径却很缺乏。本试验将评估对接受物质使用治疗的男性开展一项量身定制的综合干预措施以解决物质使用和亲密伴侣虐待行为问题的评估试验的可行性。
方法/设计:ADVANCE是一项多中心、平行组个体随机对照可行性试验,同时进行嵌套式形成性评估,将一种旨在减少亲密伴侣虐待行为与物质使用治疗的综合干预措施与仅接受常规治疗(TAU)进行比较。将招募108名在过去12个月内曾在伦敦、西米德兰兹和西南部社区物质使用治疗机构实施过亲密伴侣虐待行为的男性。ADVANCE是一种手册化干预措施,包括与一名关键工作人员进行2至4次个体辅导(其中2次为强制性辅导),以设定目标、制定个人安全计划并增强动机和意愿,随后在物质使用服务机构开展为期12周的每周一次的小组干预。男性将被随机分配(比例为1:1)接受ADVANCE干预+常规治疗或仅接受常规治疗。男性的女性(前)伴侣将被邀请提供结果数据,并获得综合安全服务(ISS)的支持。物质使用治疗机构和综合安全服务机构之间将定期召开病例管理会议以管理风险。将在干预结束时(随机分组后约4个月)获取所有男性和女性参与者的结果测量数据。这项可行性试验的主要目的是估计规划一项确定性试验所需的参数,包括各地点和分组分配的同意率、招募率和随访率。包括焦点小组和深入访谈在内的嵌套式形成性评估将探讨参与者、小组主持人、关键工作人员和综合安全服务机构工作人员对该干预措施的可接受性。次要结果包括物质使用、亲密伴侣虐待行为、心理健康、自我管理、健康和社会护理服务使用、刑事司法接触以及生活质量。
这项可行性试验的结果将为一项多中心随机对照试验的设计提供信息,该试验将评估ADVANCE干预措施在减少亲密伴侣虐待行为和改善女性(前)伴侣福祉方面的疗效和成本效益。
ISRCTN79435190。