Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), London, UK.
Institute of Education, University of Manchester, Manchester, UK.
BMJ Open. 2019 Sep 3;9(8):e029044. doi: 10.1136/bmjopen-2019-029044.
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.
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 8600 Year 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.
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.
ISRCTN17631228.
V1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).
年轻人中情绪困难的发生率正在增加。这种上升趋势在很大程度上归因于焦虑和抑郁症状的加剧。作为公共卫生应对措施的一部分,越来越强调在学校环境中提供普遍预防计划。本方案描述了一项三臂、平行组、集群随机对照试验,旨在调查两种干预措施的有效性和成本效益,同时进行过程和实施评估,以改善英国中学 9 年级学生的心理健康和幸福感。
一项三臂、平行组集群随机对照试验,比较两种不同的干预措施,即青少年心理健康意识(YAM)或心理健康和高中课程指南(指南)与常规提供的措施。总体而言,英格兰将招募 144 所中学,涉及 8600 名 9 年级学生。YAM 的主要结果是抑郁症状,而指南的主要结果是寻求帮助。这些将在干预开始后 3-6 个月和 9-12 个月进行基线测量。同时测量的次要结果包括:积极幸福感、行为困难、学校工作人员的支持、与耻辱相关的知识、态度和行为、以及心理健康急救。经济评估将评估干预措施的成本效益,而过程和实施评估(包括定性研究部分)将探索实施的几个方面(保真度、质量、剂量、范围、参与者反应性、适应性)、社会有效性(可接受性、可行性、实用性),以及它们对感兴趣的结果和感知影响的调节作用。
该试验已获得伦敦大学学院研究伦理委员会的批准。研究结果将发表在向教育部提交的报告中,以及在同行评议的期刊和会议上。
ISRCTN83344446。
V1 2019 年 1 月 3 日。方案将进行重大更改,并通知试验经理和相关方(如 ISRCTN)。