- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942637
Effectiveness of Integrated Network for Student Psychosocial Intervention, Resilience, and Education (INSPIRE) on Mental Health Outcomes Among Indonesian Adolescents in Bandung (INSPIRE)
Effectiveness of Integrated Network for Student Psychosocial Intervention, Resilience, and Education (INSPIRE) on Mental Health Outcomes Among Indonesian Adolescents in Bandung: A Randomised Controlled Trial and Process Evaluation
The INSPIRE (Integrated Network for Student Psychosocial Intervention, Resilience, and Education) intervention is an 8-week, school-based mental health program designed to enhance adolescents' mental health literacy and resilience while addressing symptoms of depression and anxiety. Implementation is conducted by school counselors who undergo an intensive two-day training program. The intervention is supported by comprehensive curriculum materials including detailed lesson plans, activities, discussion prompts, and instructional slides featuring key concepts, visuals, and explanatory content. Supplementary materials are developed for both participating adolescents and their parents.
The study aims to:
- Evaluate the usability and feasibility of the INSPIRE intervention within the school environment.
Assess the intervention's effectiveness in improving:
- Primary outcome: Mental health knowledge among adolescents
- Secondary outcomes: Attitudes toward mental health, help-seeking behaviors, mental health literacy, resilience, and symptoms of depression and anxiety among adolescents
- Secondary outcomes: mental health knowledge, attitudes, help-seeking behaviors, and mental health literacy among parents
- Explore the experiences of intervention participants (both adolescents and parents) against the control group to develop comprehensive insights into the psychosocial intervention's impact.
The research hypothesis proposes that the INSPIRE intervention group will demonstrate significantly higher scores in mental health knowledge, more positive attitudes toward mental health, increased help-seeking behaviors, enhanced mental health literacy, and greater resilience, while simultaneously showing reduced symptoms of depression and anxiety compared to the control group receiving standard care. These outcomes will be measured immediately following the intervention (post-test 1) and at one-month follow-up (post-test 2).
Study Overview
Status
Conditions
Detailed Description
Pilot Study The pilot study was conducted as a two-centre, two-arm cluster randomised controlled trial with a pre-test-post-test design and a 1:1 allocation ratio. Randomisation was performed at the school (cluster) level to minimise contamination. The pilot phase was implemented from 28 April to July 2025.
Randomised Controlled Trial (RCT) The full-scale randomised controlled trial expanded to a multi-centre design involving five centres, maintaining a two-arm cluster randomised structure with school-level allocation. The RCT commenced in September 2025 and is currently ongoing.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
West Java
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Bandung, West Java, Indonesia
- Bandung City Education Office and Junior high schools (Sekolah Menengah Pertama)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The inclusion criteria for adolescents are as follows:
- Unmarried, 13-15 years old, school-going, healthy adolescents enrolled in an Indonesian public junior high school
- Able to read, understand, and converse in Bahasa Indonesia.
The inclusion criteria for parents are as follows:
- The biological father, mother, or an adult who fulfils a parental or guardian role for the participating adolescent
- Able to understand and communicate in Bahasa Indonesia.
Exclusion Criteria:
- Adolescents who are working, clinically diagnosed with severe mental disorders, such as schizophrenia or psychosis, at high risk for mental health disorders (e.g., teenage pregnancy), or are cognitively impaired will be excluded.
- Parents with severe mental disorders or cognitive impairment that may hinder participation will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard school health routine care
|
|
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Experimental: INSPIRE Intervention
Receive an 8-week school-based program aimed at enhancing adolescent mental health, attitudes towards mental health and help-seeking behaviors, mental health literacy, resilience and addressing depression and anxiety.
|
The INSPIRE intervention is an 8-week school-based program aimed at enhancing adolescent mental health, attitudes towards mental health and help-seeking behaviors, mental health literacy, resilience and addressing depression and anxiety.
Trained school counsellors deliver this structured curriculum using comprehensive materials including lesson plans, activities, and visual aids.
the program provides supplementary resources for both participating students and their parents .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adolescents' mental health knowledge
Time Frame: Immediately following the intervention (post-test 1)
|
13-item mental health knowledge scale.
Total scores range from 0 to 13, with higher scores indicating better mental health knowledge.
|
Immediately following the intervention (post-test 1)
|
|
Adolescents' mental health knowledge
Time Frame: At one-month follow-up (post-test 2).
|
13-item mental health knowledge scale.
Total scores range from 0 to 13, with higher scores indicating better mental health knowledge.
|
At one-month follow-up (post-test 2).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adolescents' attitudes towards mental health
Time Frame: immediately following the intervention (post-test 1)
|
12-item attitude toward mental health scale.
Scores range from 12 to 60, with higher scores indicating more positive attitudes.
|
immediately following the intervention (post-test 1)
|
|
Adolescents' attitudes towards mental health
Time Frame: At one-month follow-up (post-test 2).
|
12-item attitude toward mental health scale.
Scores range from 12 to 60, with higher scores indicating more positive attitudes.
|
At one-month follow-up (post-test 2).
|
|
Adolescents' attitudes toward help-seeking behaviors
Time Frame: Immediately following the intervention (post-test 1)
|
5-item attitude toward mental help-seeking behaviors questionnaire.
Scores range from 5 to 15, with higher scores indicating more positive attitudes toward help-seeking behaviors.
|
Immediately following the intervention (post-test 1)
|
|
Adolescents' attitudes toward help-seeking behaviors
Time Frame: At one-month follow-up (post-test 2).
|
5-item attitude toward mental help-seeking behaviors questionnaire.
Scores range from 5 to 15, with higher scores indicating more positive attitudes toward help-seeking behaviors.
|
At one-month follow-up (post-test 2).
|
|
Adolescents' mental health literacy
Time Frame: Immediately following the intervention (post-test 1)
|
the 50-item Knowledge and Attitudes to Mental Health Scales, with total scores ranging from 0 to 200.
Higher scores indicated higher mental health literacy.
|
Immediately following the intervention (post-test 1)
|
|
Adolescents' mental health literacy
Time Frame: At one-month follow-up (post-test 2).
|
the 50-item Knowledge and Attitudes to Mental Health Scales, with total scores ranging from 0 to 200.
Higher scores indicated higher mental health literacy.
|
At one-month follow-up (post-test 2).
|
|
Adolescents' resilience
Time Frame: Immediately following the intervention (post-test 1)
|
the nine-item resilience evaluation scale, with the total scores ranging from 0 to 36.
Higher scores indicated higher psychological resilience.
|
Immediately following the intervention (post-test 1)
|
|
Adolescents' resilience
Time Frame: At one-month follow-up (post-test 2).
|
the nine-item resilience evaluation scale, with the total scores ranging from 0 to 36.
Higher scores indicated higher psychological resilience.
|
At one-month follow-up (post-test 2).
|
|
Adolescents' depression
Time Frame: Immediately following the intervention (post-test 1)
|
the nine-item Patient Health Questionnaire, with total scores ranging from 0 to 27.
Higher scores indicate more severe depressive symptoms.
|
Immediately following the intervention (post-test 1)
|
|
Adolescents' depression
Time Frame: At one-month follow-up (post-test 2).
|
the nine-item Patient Health Questionnaire, with total scores ranging from 0 to 27.
Higher scores indicate more severe depressive symptoms.
|
At one-month follow-up (post-test 2).
|
|
Adolescents' anxiety
Time Frame: Immediately following the intervention (post-test 1)
|
the 7-item Generalized Anxiety Disorder scale, with total scores ranging from 0 to 21.
Higher scores indicate more severe anxiety symptoms.
|
Immediately following the intervention (post-test 1)
|
|
Adolescents' anxiety
Time Frame: At one-month follow-up (post-test 2).
|
the 7-item Generalized Anxiety Disorder scale, with total scores ranging from 0 to 21.
Higher scores indicate more severe anxiety symptoms.
|
At one-month follow-up (post-test 2).
|
|
Parents' mental health knowledge
Time Frame: Immediately following the intervention (post-test 1)
|
13-item mental health knowledge scale.
Total scores range from 0 to 13, with higher scores indicating better mental health knowledge.
|
Immediately following the intervention (post-test 1)
|
|
Parents' mental health knowledge
Time Frame: At one-month follow-up (post-test 2).
|
13-item mental health knowledge scale.
Total scores range from 0 to 13, with higher scores indicating better mental health knowledge.
|
At one-month follow-up (post-test 2).
|
|
Parents' attitudes towards mental health
Time Frame: immediately following the intervention (post-test 1)
|
12-item attitude toward mental health scale.
Scores range from 12 to 60, with higher scores indicating more positive attitudes.
|
immediately following the intervention (post-test 1)
|
|
Parents' attitudes towards mental health
Time Frame: At one-month follow-up (post-test 2).
|
12-item attitude toward mental health scale.
Scores range from 12 to 60, with higher scores indicating more positive attitudes.
|
At one-month follow-up (post-test 2).
|
|
Parents' attitudes toward help-seeking behaviors
Time Frame: Immediately following the intervention (post-test 1)
|
5-item attitude toward mental help-seeking behaviors questionnaire.
Scores range from 5 to 15, with higher scores indicating more positive attitudes toward help-seeking behaviors.
|
Immediately following the intervention (post-test 1)
|
|
Parents' attitudes toward help-seeking behaviors
Time Frame: At one-month follow-up (post-test 2).
|
5-item attitude toward mental help-seeking behaviors questionnaire.
Scores range from 5 to 15, with higher scores indicating more positive attitudes toward help-seeking behaviors.
|
At one-month follow-up (post-test 2).
|
|
Parents' mental health literacy
Time Frame: Immediately following the intervention (post-test 1)
|
The 16-item Mental Health Literacy Questionnaire, with total scores ranging from 16 to 80. Higher scores indicated higher mental health literacy.
|
Immediately following the intervention (post-test 1)
|
|
Parents' mental health literacy
Time Frame: At one-month follow-up (post-test 2).
|
The 16-item Mental Health Literacy Questionnaire, with total scores ranging from 16 to 80. Higher scores indicated higher mental health literacy.
|
At one-month follow-up (post-test 2).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 241/UN6.KEP/EC/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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