Computerized Single-Session Interventions for 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. The investigators will be examining the effects of three interventions on the well-being and mental health of adolescents. The investigators hypothesize that at least one of the three interventions 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 Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents

Conditions
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Well-being, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Growth Mindset
* Behavioral: Gratitude
* Behavioral: Behavioral Activation
* Behavioral: Study Skills


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: Growth Mindset<br> | Behavioral: Growth Mindset<br>* Reading and writing activities designed to instill the belief that people can change.<br>|
| Experimental: Gratitude<br> | Behavioral: Gratitude<br>* Reading and writing activities designed to practice noticing and appreciating good things in life.<br>|
| Experimental: Behavioral Activation<br> | Behavioral: Behavioral Activation<br>* Reading and writing activities designed to identify and schedule positive activities.<br>|
| Sham Comparator: Study Skills<br> | Behavioral: Study Skills<br>* Reading and writing activities designed to learn 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. | 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. | Baseline, 4 week follow-up, 12 week follow-up |