Promoting Mental Health Among At-risk Adolescents in Malaysia

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in adolescent's anxiety and depression [Срок оценки: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.]
• Change in adolescent's wellbeing [Срок оценки: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.]

Вторичные конечные точки (7)

• Change in adolescent's emotion regulation strategies. [Срок оценки: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.]
• Change in adolescent's suicidal behaviour. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.]
• Change in adolescent's executive function. [Срок оценки: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.]
• Change in the severity of anxiety and depressive symptoms. [Срок оценки: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.]
• Change in adolescent's lifestyle habits. [Срок оценки: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

(1) Being diagnosed with neurodevelopmental disorders. (2) Being diagnosed with intellectual disability.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Малайзия · 5 центров

• Fakulti Psikologi Dan Pendidikan — Kota Kinabalu
• Universiti Malaysia Sarawak — Kuching
• Universiti Kebangsaan Malaysia — Bangi
• Universiti Malaya — Kuala Lumpur
• Sunway University — Subang Jaya

Публикации

• 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

Идентификаторы

NCT: NCT07138664 · PSYC 23-483

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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