Promoting Mental Health Among At-risk Adolescents in Malaysia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Super Skills for Life program, Study-Skills program.
- Who it may be relevant to
- Registry conditions: Depression in Adolescence, Anxiety. Basic parameters: 12 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in adolescent's anxiety and depression [Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.]
- Change in adolescent's wellbeing [Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.]
Secondary outcome measures (7)
- Change in adolescent's emotion regulation strategies. [Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.]
- Change in adolescent's suicidal behaviour. [Time frame: 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. [Time frame: 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. [Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.]
- Change in adolescent's executive function. [Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.]
- Change in the severity of anxiety and depressive symptoms. [Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.]
- Change in adolescent's lifestyle habits. [Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
(1) Being diagnosed with neurodevelopmental disorders. (2) Being diagnosed with intellectual disability.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Malaysia · 5 centers
- Fakulti Psikologi Dan Pendidikan — Kota Kinabalu
- Universiti Malaysia Sarawak — Kuching
- Universiti Kebangsaan Malaysia — Bangi
- Universiti Malaya — Kuala Lumpur
- Sunway University — Subang Jaya
Publications
- Essau CA, Zakaria S, Ting CH, Lee JAC, de la Torre-Luque A, Ng ALO, Majid HA, Dodd H, Nik Farid ND, Muhammad NA, Wahab S. Promoting mental health among at-risk adolescents in Malaysia (MyHeRo): study protocol for a cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a school-based intervention compared with study skills condition for adolescents identified a PMID 41593785
Identifiers
NCT: NCT07138664 · PSYC 23-483