Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents

Not Applicable

Withdrawn

• Conditions: Well-Being; Depression; Anxiety
• Interventions: Behavioral: Growth, Gratitude, & Positive Activities; Behavioral: Study Skills Control

• Registration Number: NCT04020549
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-16
• Study Start: 2019-07-31
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Attending a participating secondary school
• Age 12 to 18
• Literate in English

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Exclusion Criteria

• Unable to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Growth, Gratitude, & Positive Activities	-
Study Skills Control	Study Skills Control	-

Primary Outcome Measures

Name	Time	Method
Intervention Appropriateness Measure	Immediately post-intervention (i.e., 0 weeks)	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.
Change in The Warwick-Edinburgh Mental Wellbeing Scale	Baseline, 4 week follow-up, 12 week follow-up	Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	Baseline, 4 week follow-up, 12 week follow-up	Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.
Acceptability of Intervention Measure	Immediately post-intervention (i.e., 0 weeks)	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.
Perceived Stress Scale-4	Time Frame: Baseline, 4 week follow-up, 12 week follow-up	Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.
Generalized Anxiety Disorder Screener-7	Baseline, 4 week follow-up, 12 week follow-up	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.
The EPOCH Measure of Adolescent Well-being	Baseline, 4 week follow-up, 12 week follow-up	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.
Feasibility of Intervention Measure	Immediately post-intervention (i.e., 0 weeks)	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.

Trial Locations

Locations (1)

Z P school, Wablewadi; 🇮🇳 Pune, Maharashtra, India