Tran Thach, Nguyen Huong Thanh, Shochet Ian, Wurfl Astrid, Orr Jayne, Nguyen Nga, La Nga, Nguyen Hau, Stocker Ruby, Nguyen Trang, Le Minh, Fisher Jane
Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Department of Health Education, Faculty of Social Science, Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam.
BMJ Open. 2020 Oct 16;10(10):e039343. doi: 10.1136/bmjopen-2020-039343.
The Resourceful Adolescent Program (RAP) is an evidence-based resilience intervention for adolescents. Operating in a strength-focused paradigm, the programme uses an integration of cognitive behavioural therapy and interpersonal psychotherapy to improve coping skills and build resilience. This study aims to establish whether a culturally and linguistically adapted intervention informed by RAP principles is effective in increasing resilience, enhancing coping skills and preventing symptoms of depression and anxiety.
We will translate, back-translate and culturally adapt the RAP for adolescents and training materials for facilitators, and the adapted intervention will be called Happy House. A two-arm parallel controlled trial will be conducted in eight high schools in the north of Vietnam. In each of the selected schools, all students from four randomly selected grade 10 classes (an estimation of about 1204 students) will be invited to participate. The control group will receive the usual curriculum. The intervention group will receive six weekly 90 min school-based group sessions of Happy House in addition to the usual curriculum. The primary outcome, depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised. Secondary outcomes are mental well-being, coping self-efficacy, school connectedness, anger management and health risk behaviours. Data will be collected at recruitment, and at two weeks and six months post intervention. Mixed-effect logistic regression for the main outcome and mixed-effect linear and logistic regression models for the secondary outcomes will be conducted to estimate the effects of the intervention on the outcomes.
This trial has been approved by Monash University Human Research Ethics Committee (No. 21455) and the Institutional Review Board of the Hanoi School of Public Health (488/2019/YTCC-HD3). Dissemination of findings will include peer-reviewed publications, international and national conferences, seminar and media presentations, national policy briefings in Vietnam, local language reports and lay language summaries for participants.
Registered with the Australian New Zealand Clinical Trials Registry, registration number: ACTRN12620000088943 (3/2/2020).WHO Universal Trial Number: U1111-1246-4079.
青少年资源计划(RAP)是一项基于证据的针对青少年的复原力干预措施。该计划以关注优势的模式开展,将认知行为疗法和人际心理治疗相结合,以提高应对技能并培养复原力。本研究旨在确定一项受RAP原则启发、在文化和语言上进行调整的干预措施是否能有效提高复原力、增强应对技能并预防抑郁和焦虑症状。
我们将对针对青少年的RAP及促进者培训材料进行翻译、回译和文化调整,调整后的干预措施将被称为“快乐之家”。将在越南北部的八所高中进行双臂平行对照试验。在每所选定的学校,将邀请从四个随机选择的十年级班级中挑选出的所有学生(预计约1204名学生)参与。对照组将接受常规课程。干预组除接受常规课程外,还将参加为期六周、每周90分钟的以学校为基础的“快乐之家”小组课程。主要结局指标为抑郁症状,将使用当地验证的修订版流行病学研究中心抑郁量表进行测量。次要结局指标包括心理健康、应对自我效能感、学校归属感、愤怒管理和健康风险行为。将在招募时以及干预后两周和六个月收集数据。将对主要结局进行混合效应逻辑回归分析,对次要结局进行混合效应线性和逻辑回归模型分析,以估计干预措施对结局的影响。
本试验已获得莫纳什大学人类研究伦理委员会(编号:21455)和河内公共卫生学院机构审查委员会(488/2019/YTCC-HD3)的批准。研究结果的传播将包括同行评审出版物、国际和国家会议、研讨会及媒体展示、越南的国家政策简报、当地语言报告以及面向参与者的通俗易懂的总结。
在澳大利亚新西兰临床试验注册中心注册,注册号:ACTRN12620000088943(2020年2月3日)。世界卫生组织通用试验编号:U1111-1246-4079。