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 as at risk for anxiety and depression

Abstract

Abstract Background In Malaysia, adolescent anxiety and depression are increasing faster than ever, and rates of suicidal behaviour are rising especially among those living in deprived communities. However, Malaysia’s mental health system is currently constrained by limited workforce capacity, affecting the delivery of effective interventions. 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 determine the characteristics of adolescents who benefit from SSL, compared to those who do not, as well as to identify contextual factors related to the successful implementation of SSL in Malaysian schools.

Methods The design will be a two-arm, cluster randomised controlled trial comparing school-based intervention (Super Skills for Life; SSL) to study skills control condition (Study Skills Programme; SSP) using a 1:1 allocation ratio. Classrooms will be the cluster unit for randomisation. Three stratification factors will be used for randomisation: school size, classes/forms and school location (urban vs rural). The study will recruit adolescents in at least 20 secondary schools in economically deprived, rural and urban regions in Malaysia. These adolescents will be invited to complete a screening questionnaire (i.e. Depression Anxiety and Stress Scale-21; DASS-21). Based on power calculation, 428 adolescents (214 per arm) who experience moderate to severe levels of anxiety and depression on the DASS-21 will be invited to participate in the trial. Classes will be randomly allocated to SSL or SSP, with eligible adolescents from each class receiving the allocated intervention. Assessment will be conducted at screening, at pre- (i.e. baseline) and post-intervention (i.e. 2 months), and at two follow-ups (i.e. 6 and 12 months post-intervention). The primary outcomes will be a reduction in anxiety and depressive symptoms, and an improvement in mental wellbeing at 12 months post-intervention.

Discussion 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. The findings will advance understanding of the role of school staff in the delivery of a school-based intervention and will generate new knowledge on the role of socio-cultural and other contextual factors in predicting intervention uptake and treatment outcome.

Trial registration ClinicalTrials.gov NCT07138664. Registered on August 16, 2025.