Promoting Mental Health Among At-risk Adolescents in Malaysia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 428
- 试验地点
- 5
- 主要终点
- Change in adolescent's anxiety and depression
研究概览
简要总结
The primary objective of this trial is to evaluate a school-based intervention designed to promote mental health among at-risk adolescents from low-income communities in Malaysia. The study will employ a two-arm, cluster randomised controlled trial design, comparing a school-based intervention to a control condition. Adolescents will be recruited from at least 20 secondary schools located in economically disadvantaged rural and urban areas of Malaysia. Assessments will take place at multiple time points: during screening, at baseline (pre-intervention), immediately after the intervention (8 weeks), and at two follow-up points-6 and 12 months post-intervention. The primary outcomes are a reduction in anxiety and depressive symptoms, along with improved mental wellbeing at the 12-month follow-up.
详细描述
The overall aim of this trial is to use a school-based intervention to promote mental health among at-risk adolescents from low-income communities in Malaysia. Our primary aim is to evaluate the effectiveness and cost-effectiveness of a school-based intervention ("Super Skills for Life"; SSL) in reducing anxiety and depression, and in improving mental wellbeing in adolescents aged 12-14 years. We also aim to identify contextual factors related to the successful implementation of SSL in Malaysian schools.
This study will use a two-arm, cluster randomised controlled trial design with a 1:1 allocation ratio to compare a school-based intervention (Super Skills for Life; SSL) to a control condition (Study Skills Programme; SSP). Three stratification factors will be used for randomisation: school size, classes/forms and school location (urban vs rural). These adolescents will be invited to complete a screening questionnaire (i.e., Depression Anxiety and Stress Scale-21; DASS-21).
Based on power calculations, a total of 428 adolescents (214 per arm) with moderate to severe symptoms of anxiety and depression will be recruited to participate in the trial. Classrooms will be randomly assigned to either the intervention or control group, and eligible adolescents within each class will receive the intervention assigned to their group. Assessments will be conducted at screening, baseline (pre-intervention), immediately after the intervention (8 weeks), and at two follow-up points-6 and 12 months post-intervention. The primary outcomes will include reductions in anxiety and depressive symptoms, along with improvements in mental wellbeing at the 12-month follow-up.
Findings of this trial will determine if delivering a group school-based intervention by school staff for adolescents at risk of anxiety and depression is effective and cost-effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent (aged 12-14) who are in the first two years (Form 1 and Form 2, equivalent to year 7 and 8 in the United Kingdom school system, respectively) in lower secondary schools.
- •Adolescents score moderate to severe levels of anxiety and/or depression on the Depression Anxiety and Stress Scale-21 (DASS-21) based on the original cut-off norms (DASS-21 Anxiety scale ≥ 10 and/or DASS-21 Depression scale ≥ 14).
- •Adolescent's parent/carer provides written consent.
排除标准
- •(1) Being diagnosed with neurodevelopmental disorders. (2) Being diagnosed with intellectual disability.
研究组 & 干预措施
Super Skills for Life program
A manualized psychosocial program for preventing anxiety and depression and for promoting healthy lifestyles (called "Super Skills for Life; SSL"). SSL focuses on: (1) teaching about healthy lifestyles; (2) building emotional resilience through stress management; (3) encouraging peer learning and building peer networks; and (4) promoting self-confidence and social skills. These key elements are organized over 8 weekly sessions in a group format (45-60 minutes per session).
干预措施: Super Skills for Life program (Behavioral)
Study-Skills program
Study-Skills program will be implemented in a group format (45-60 minutes per session) in 8 weekly sessions, covering: note-taking skills, effective study strategies, and time management.
干预措施: Study-Skills program (Behavioral)
结局指标
主要结局
Change in adolescent's anxiety and depression
时间窗: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
The Revised Children's Anxiety and Depression Scale will be used to identify symptoms of anxiety and depressive disorder in adolescents. It contains 6 items for measuring anxiety and 5 items for depression symptoms, which are to be rated on a 4-point Likert Scale from 0 ("never") to 3 ("always").
Change in adolescent's wellbeing
时间窗: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
Short Warwick-Edinburgh Mental Well-being Scale will be used to measure mental wellbeing. All its 7 items are worded positively and cover feeling and functioning aspects of mental wellbeing. The items can be rated on a 5-point scale from 1 (none of the time) to 5 (all of the time).
次要结局
- Change in adolescent's emotion regulation strategies.(Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.)
- Change in adolescent's suicidal behaviour.(Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.)
- Change in adolescent's ability to carry out essential social behaviors.(Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.)
- Change in adolescent's working memory and inhibition.(Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.)
- Change in adolescent's executive function.(Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.)
- Change in the severity of anxiety and depressive symptoms.(Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.)
- Change in adolescent's lifestyle habits.(Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.)
研究者
Cecilia Essau
Professor of Developmental Psychopathology
University of Roehampton