School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)
School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)
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DOI：
10.1136/bmjopen-2019-029044
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发表时间：
2019-08-01
期刊：
影响因子：
2.9
通讯作者：
Deighton, Jessica
中科院分区：
文献类型：
--
作者：
Hayes, Daniel;Moore, Anna;Deighton, Jessica
引言年轻人的情绪困难的患病率正在增加。这种上升趋势主要是由于焦虑和抑郁症状的不断升级。作为公共卫生对策的一部分，越来越重视在学校环境中提供的普遍预防方案。该方案描述了一个三臂，平行组群集随机对照试验，调查两种干预措施的有效性和成本效益，以及过程和实施评估，以改善英国中学9年级学生的心理健康和福祉。青少年心理健康意识（YAM）或心理健康和高中课程指南（指南），以学校提供。总的来说，将在英格兰招募144所中学，涉及8600名9年级学生。YAM的主要结果是抑郁症状，而指南的目的是寻求帮助。这些将在基线、干预开始后3-6个月和9-12个月进行测量。同时衡量的次要成果包括以下方面的变化：积极的幸福感、行为困难、学校工作人员的支持、与耻辱有关的知识、态度和行为以及心理健康急救。一项经济评价将评估干预措施的成本效益，以及一项过程和执行评价（包括定性研究部分）将探讨实施的几个方面（忠诚度、质量、剂量、覆盖范围、参与者反应、适应）、社会有效性（可接受性、可行性、效用）及其对感兴趣结果的调节作用，伦理和传播本试验已获得伦敦大学学院研究伦理委员会的批准。研究结果将在提交给教育部的报告、同行评审期刊和会议上发表。试验注册号ISRCTN17631228.Protocol V1 2019年1月3日。方案的实质性变更将传达给试验经理和相关方（例如，ISRCTN）。
Introduction The prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.Method A three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3-6 months and 9-12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and dissemination This trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.Protocol V1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).