Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial.
Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial.
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DOI：
10.1186/s13063-016-1506-y
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发表时间：
2016-07-29
期刊：
影响因子：
2.5
通讯作者：
Clarke M
中科院分区：
文献类型：
--
作者：
Aventin Á;Lohan M;Maguire L;Clarke M
向循证教育的转变导致学校里随机试验的数量不断增加。然而，与临床试验相比，关于非临床试验招募的文献相对不发达。然而，以学校为基础的随机试验的招募具有挑战性，当研究重点是诸如性健康这样的敏感问题时，更是如此。本文反思了在一项性健康干预的整群随机可行性试验中招募小学后学校、青少年学生和家长所面临的挑战，以及为应对这些挑战所采用的策略。
杰克试验由英国国家卫生研究院资助。它包括对一项名为《如果我是杰克》的基于互动电影的性健康干预的可行性研究，从北爱尔兰8所社会人口统计学不同的小学后学校招募了800多名青少年。其目的是确定在以学校为基础的性健康试验中招募和留存的促进因素和障碍，并确定有效性研究的最佳多层次策略。作为嵌入式过程评估的一部分，我们对参与研究的校长、副校长、教师、学生和家长进行了半结构化访谈和焦点小组讨论，还进行了课堂观察和家长调查。
参照社会学习理论，我们确定了一些影响招募的个人层面、行为层面和环境层面的因素。普遍确定的促进因素包括对干预措施对青少年的相关性和潜在益处的认知、开展研究的组织和个人的可信度、试验工作人员提供的支持以及经济激励。关键障碍包括事先对其他研究的承诺、缺乏时间和资源，以及认为干预措施与学生或家长的需求或学校风气不相符的看法。
通过反思在以学校为基础的性健康可行性试验中招募所面临的方法学挑战，本研究强调了相关的一般性和特定于试验的招募促进因素和障碍，这将对未来针对学校、青少年学生和家长的试验有用。
ISRCTN 11632300。2014年12月19日注册。
The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. Recruitment to school-based randomised trials is, however, challenging, even more so when the focus of the study is a sensitive issue such as sexual health. This article reflects on the challenges of recruiting post-primary schools, adolescent pupils and parents to a cluster randomised feasibility trial of a sexual-health intervention, and the strategies employed to address them. The Jack Trial was funded by the UK National Institute for Health Research. It comprised a feasibility study of an interactive film-based sexual-health intervention entitled If I Were Jack, recruiting over 800 adolescents from eight socio-demographically diverse post-primary schools in Northern Ireland. It aimed to determine the facilitators and barriers to recruitment and retention to a school-based sexual-health trial and identify optimal multi-level strategies for an effectiveness study. As part of an embedded process evaluation, we conducted semi-structured interviews and focus groups with principals, vice-principals, teachers, pupils and parents recruited to the study as well as classroom observations and a parents’ survey. With reference to social learning theory, we identified a number of individual-, behavioural- and environmental-level factors that influenced recruitment. Commonly identified facilitators included perceptions of the relevance and potential benefit of the intervention to adolescents, the credibility of the organisation and individuals running the study, support offered by trial staff, and financial incentives. Key barriers were prior commitment to other research, lack of time and resources, and perceptions that the intervention was incompatible with pupil or parent needs or the school ethos. Reflecting on the methodological challenges of recruiting to a school-based sexual-health feasibility trial, this study highlights pertinent general and trial-specific facilitators and barriers to recruitment, which will prove useful for future trials with schools, adolescent pupils and parents. ISRCTN 11632300. Registered on 19 December 2014.