Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents

Study Overview
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Brief Summary
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The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents attending a rural, low-resource government school. The investigators will be examining the effects of a computerized intervention on the well-being and mental health of adolescents. The investigators hypothesize that the intervention will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.

Official Title
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Evaluating the Effectiveness of a Computerized, School-Based, Single-Session Intervention for Rural Indian Adolescents

Conditions
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Well-Being, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Growth, Gratitude, & Positive Activities
* Behavioral: Study Skills Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Attending a participating secondary school Age 12 to 18 Literate in English Exclusion Criteria: Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Growth, Gratitude, & Positive Activities<br>* Reading and writing activities based on growth (designed to instill the belief that people can change), gratitude (noticing and appreciating good things in life), and behavioral activation (identifying and scheduling positive activities).<br>|
| Sham Comparator: Study Skills Control<br> | Behavioral: Study Skills Control<br>* Reading and writing activities designed to teach evidence-based study strategies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Warwick-Edinburgh Mental Wellbeing Scale | Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up | 
| Intervention Appropriateness Measure | Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 | Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up | 
| Generalized Anxiety Disorder Screener-7 | Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome. Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome. Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome. Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome. Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up | 
| The EPOCH Measure of Adolescent Well-being | Questionnaire with five subscales measuring engagement, perseverance, optimism, connectedness, and happiness. Each subscale score ranges from 4 to 20. Higher scores indicate a better outcome. The happiness and optimism subscales will be used as secondary outcomes for this trial. A total score is not computed. | Baseline, 4 week follow-up, 12 week follow-up | 
| Acceptability of Intervention Measure | Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) | 
| Feasibility of Intervention Measure | Questionnaire measuring the feasibility of an intervention. Feasibility refers to the degree to which a treatment can be successfully implemented in a given setting. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) | 
| Perceived Stress Scale-4 | Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome. | Time Frame: Baseline, 4 week follow-up, 12 week follow-up |