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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
428
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.
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.
Fakulti Psikologi Dan Pendidikan
Kota Kinabalu, Sabah, Malaysia
RECRUITINGUniversiti Malaysia Sarawak
Kuching, Sarawak, Malaysia
RECRUITINGUniversiti Kebangsaan Malaysia
Bangi, Selangor, Malaysia
RECRUITINGUniversiti Malaya
Kuala Lumpur, Selangor, Malaysia
RECRUITINGSunway University
Subang Jaya, Selangor, Malaysia
RECRUITINGChange in adolescent's anxiety and depression
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").
Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
Change in adolescent's wellbeing
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).
Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
Change in adolescent's emotion regulation strategies.
Cognitive Emotion Regulation Questionnaire will be used to measure emotion regulation strategies. It consists of 18 items, which can be rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always) in response to how often each of the 9 emotion regulation strategies are used: refocus on planning, putting into perspective, acceptance, positive refocusing, positive reappraisal, self-blame, other blame, rumination, and catastrophizing.
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's suicidal behaviour.
The Paykel Suicide Scale (PSS) will be used to measure suicidal behaviour. The scale consists of 5 items, with a dichotomous response system, i.e., Yes or No.
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.
The Social Skills Questionnaire will be used to measure essential social behaviors that contribute to success in social interactions. Its 13 items can be are rated from 0 (Not true), 1 (Sometimes true) to 2 (Mostly true).
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.
Teenage Executive Functioning Inventory will be used to measure working memory and inhibition. It contains 20 items which can be rated on a 5-point Likert scale ranging from 1 ("definitely not true") to 5 ("definitely true").
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's executive function.
Executive function will also be measured using milliseconds experimental task to measure attention control and working memory.
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.
Depression Anxiety and Stress Scale-21 (DASS-21) will be used to measure adolescent's severity of anxiety and depressive symptoms. The DASS-21 consists of 21 items which are divided equally across the anxiety, depressive and stress subscales, which can be rated on a 4-point Likert Scale (range from 0 \[did not apply to me at all\] to 3 \[applied to me very much or most of the time\]).
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's lifestyle habits.
Lifestyle and Habits Questionnaire (LHQ-B) will be used to measure adolescent's lifestyle habits (physical activity and exercise, sleep and sleep hygiene, and type of food consumption). LHQ-B contains 16 items which ask adolescents about how frequently they perform each behaviour in the past 30 days on a 5-point scale from "never" to "always".
Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
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