Beames Joanne R, Lingam Raghu, Boydell Katherine, Calear Alison L, Torok Michelle, Maston Kate, Zbukvic Isabel, Huckvale Kit, Batterham Philip J, Christensen Helen, Werner-Seidler Aliza
Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia.
School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open. 2021 Jan 12;11(1):e042133. doi: 10.1136/bmjopen-2020-042133.
Process evaluations provide insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a cluster randomised trial of a digital depression prevention intervention delivered to secondary school students (the Future Proofing Study). The purpose is to describe the methods that will be used to capture process evaluation data within this trial.
Using a hybrid type 1 design, a mixed-methods approach will be used with data collected in the intervention arm of the Future Proofing Study. Data collection methods will include semistructured interviews with school staff and study facilitators, automatically collected intervention usage data and participant questionnaires (completed by school staff, school counsellors, study facilitators and students). Information will be collected about: (1) how the intervention was implemented in schools, including fidelity; (2) school contextual factors and their association with intervention reach, uptake and acceptability; (3) how school staff, study facilitators and students responded to delivering or completing the intervention. How these factors relate to trial effectiveness outcomes will also be assessed. Overall synthesis of the data will provide school cluster-level and individual-level process outcomes.
Ethics approval was obtained from the University of New South Wales (NSW) Human Research Ethics Committee (HC180836; 21st January 2019) and the NSW Government State Education Research Applications Process (SERAP 2019201; 19th August 2019). Results will be submitted for publication in peer-reviewed journals and discussed at conferences. Our process evaluation will contextualise the trial findings with respect to how the intervention may have worked in some schools but not in others. This evaluation will inform the development of a model for rolling out digital interventions for the prevention of mental illness in schools.
ANZCTRN12619000855123; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377664&isReview=true.
过程评估有助于深入了解干预措施在不同背景下是如何实施的，以及为何干预措施在某些背景下有效而在其他背景下无效。本手稿概述了一项过程评估的方案，该评估嵌入了一项针对中学生的数字抑郁症预防干预措施的整群随机试验（“未来保障研究”）。目的是描述将用于在此试验中收集过程评估数据的方法。
采用混合1型设计，将使用混合方法收集“未来保障研究”干预组的数据。数据收集方法将包括对学校工作人员和研究促进者的半结构化访谈、自动收集的干预使用数据以及参与者问卷（由学校工作人员、学校辅导员、研究促进者和学生填写）。将收集以下方面的信息：（1）干预措施在学校中的实施方式，包括保真度；（2）学校背景因素及其与干预覆盖范围、采用率和可接受性的关联；（3）学校工作人员、研究促进者和学生对实施或完成干预措施的反应。还将评估这些因素与试验有效性结果的关系。数据的总体综合将提供学校整群层面和个体层面的过程结果。
已获得新南威尔士大学（NSW）人类研究伦理委员会（HC180836；2019年1月21日）和新南威尔士州政府州教育研究申请程序（SERAP 2019201；2019年8月19日）的伦理批准。结果将提交至同行评审期刊发表，并在会议上进行讨论。我们的过程评估将根据干预措施在某些学校有效而在其他学校无效的情况，对试验结果进行背景分析。该评估将为制定在学校推广数字干预措施以预防精神疾病的模型提供参考。
ANZCTRN12619000855123；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377664&isReview=true。
