NCT07138664

Promoting Mental Health Among At-risk Adolescents in Malaysia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: University of Roehampton · Academic / Other
• Sex: All
• Age: 12 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Depression in Adolescence
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Super Skills for Life 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.
BEHAVIORAL	Study-Skills program	Study-Skills program will be used as a comparator intervention, which 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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

5 sites across 1 country: Malaysia