York Trials Unit, Department of Health Sciences, University of York, York, UK.
School of Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
Public Health Res (Southampt). 2024 Sep;12(7):1-111. doi: 10.3310/NTFW7364.
Young adults represent a third of the United Kingdom prison population and are at risk of poor health outcomes, including drug and alcohol misuse, self-harm and suicide. Court diversion interventions aim to reduce the negative consequences of criminal sanctions and address the root causes of offending. However, evidence of their effectiveness has not yet been established. The Gateway programme, issued as a conditional caution, aimed to improve the life chances of young adults committing low-level offences. Participants agreed not to reoffend during the 16-week caution and, following a needs assessment, received individual support from a Gateway navigator and attended two workshops encouraging analysis of own behaviour and its consequences.
To evaluate the effectiveness and cost-effectiveness of Gateway in relation to health and well-being of participants compared to usual process (court summons or a different conditional caution).
DESIGN, SETTING AND PARTICIPANTS: Pragmatic, multisite, parallel-group, superiority randomised controlled trial with two 6-month internal pilots and a target sample size of 334. Randomisation between Gateway and usual process was on a 1 : 1 basis. Four Hampshire Constabulary sites recruited 18- to 24-year-old residents of Hampshire and Isle of Wight who were questioned for an eligible low-level offence. Semistructured interviews were also held with a sample of Gateway programme participants, staff and police study recruiters.
Primary outcome was the Warwick-Edinburgh Mental Wellbeing Scale score at 12 months. Secondary outcomes included health status, alcohol and drug use, recidivism and resource use.
Recruitment commenced in October 2019 and the trial stopped in April 2021. A total of 191 participants were recruited, with 109 randomised to Gateway and 82 to usual process. Due to an initial overestimation of potentially eligible young people and low retention rates, recruitment targets were adjusted, and a range of mitigating measures introduced. Although recruitment broadly met study progression criteria [35/50 (70%) Pilot 1: 64/74 (86%) Pilot 2], retention was low throughout (overall: data collected at week 4 was 50%: at week 16 it was 50%: 1-year 37%). Low retention was multifactorial, with one of the main barriers being difficulties contacting participants. It was therefore not possible to complete the randomised controlled trial or the health economics analyses. Qualitative interviews held with 58 individuals yielded rare insights into the benefits and limitations of this type of intervention, as well as barriers and facilitators in relation to recruitment in this setting.
Despite close collaboration with the police to address recruitment and consent issues, expansion of the inclusion criteria and recruitment area and introducing other measures, the researchers were unable to collect sufficient data within an acceptable timeframe.
The Gateway study was a unique endeavour to gather evidence for a potentially life-changing intervention for an underserved population. The experience gained indicates that randomised controlled trials of interventions, with a health-related outcome, are possible in this setting but point towards the need for conservative recruitment and retention estimates in this target population. Other study designs should be considered. The qualitative evaluation provided a range of valuable lessons for those seeking to design similar interventions or conduct research in similar settings.
This study is registered as ISRCTN11888938.
This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 16/122/20) and is published in full in ; Vol. 12, No. 7. See the NIHR Funding and Awards website for further award information.
年轻人占英国监狱人口的三分之一,他们面临着健康状况不佳的风险,包括药物和酒精滥用、自残和自杀。法庭转移干预措施旨在减少刑事制裁的负面影响,并解决犯罪的根本原因。然而,其有效性的证据尚未确立。“门户”计划作为有条件警告发出,旨在改善犯有低级别罪行的年轻人的生活机会。参与者同意在 16 周的警告期内不再犯罪,在进行需求评估后,他们将获得“门户”导航员的个人支持,并参加两个鼓励分析自己行为及其后果的讲习班。
评估“门户”计划在参与者的健康和福祉方面与常规程序(法庭传票或不同的有条件警告)相比的有效性和成本效益。
设计、地点和参与者:务实、多地点、平行组、优势随机对照试验,有两个 6 个月的内部试验和 334 名的目标样本量。在“门户”和常规程序之间进行 1:1 的随机分组。四个汉普郡警察局站点招募了居住在汉普郡和怀特岛的 18 至 24 岁的居民,他们因符合条件的低级别犯罪而受到讯问。还对“门户”计划的参与者、工作人员和警方研究招募人员进行了抽样半结构化访谈。
主要结果是 12 个月时的华威-爱丁堡心理健康量表评分。次要结果包括健康状况、酒精和药物使用、累犯和资源使用。
招募工作于 2019 年 10 月开始,试验于 2021 年 4 月停止。共招募了 191 名参与者,其中 109 名随机分配到“门户”组,82 名分配到常规程序组。由于最初对潜在合格的年轻人估计过高和保留率低,调整了招募目标,并引入了一系列缓解措施。尽管招募总体上符合研究进展标准[50/50(70%)第 1 个试验:64/74(86%)第 2 个试验],但保留率一直很低(总体:第 4 周收集的数据为 50%:第 16 周为 50%:1 年时为 37%)。低保留率是多方面的,其中一个主要障碍是难以联系到参与者。因此,无法完成随机对照试验或健康经济学分析。对 58 人进行的定性访谈提供了有关此类干预措施的益处和局限性的罕见见解,以及在这种环境下招募的障碍和促进因素。
尽管与警方密切合作解决了招募和同意问题、扩大了纳入标准和招募区域,并采取了其他措施,但研究人员仍无法在可接受的时间内收集足够的数据。
“门户”研究是一项独特的努力,旨在为服务不足的人群提供一项可能改变生活的干预措施的证据。所获得的经验表明,在这种环境下,针对健康相关结果的干预措施的随机对照试验是可行的,但指出在目标人群中需要保守的招募和保留估计。应该考虑其他研究设计。定性评估为那些寻求设计类似干预措施或在类似环境中进行研究的人提供了一系列宝贵的经验教训。
这项研究在 ISRCTN 注册,编号为 ISRCTN11888938。
这项资助由英国国家卫生与保健研究署(NIHR)公共卫生研究计划(NIHR 拨款编号:16/122/20)提供,并在 ; 第 12 卷,第 7 期。有关进一步的拨款信息,请访问 NIHR 拨款和奖项网站。