Computerized Single-Session Interventions for Indian Adolescents

Not Applicable

Completed

• Conditions: Anxiety; Well-being; Depression
• Interventions: Behavioral: Growth Mindset; Behavioral: Study Skills; Behavioral: Gratitude; Behavioral: Behavioral Activation

• Registration Number: NCT03982563
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-11
• Study Start: 2019-07-31
• Primary Completion: 2020-03-15
• Status Verified: 2020-06
• Study Completion: 2020-06-04
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 958

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
Growth Mindset	Growth Mindset	-
Study Skills	Study Skills	-
Gratitude	Gratitude	-
Behavioral Activation	Behavioral Activation	-

Primary Outcome Measures

Name	Time	Method
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.
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.

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.
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.
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.
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.
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.
Perceived Stress Scale-4	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.

Trial Locations

Locations (4)

Modern College Pune; 🇮🇳 Pune, India

JM Rathi English School; 🇮🇳 Roha, Maharashtra, India

Dr. Kalmadi Junior High School; 🇮🇳 Pune, Maharashtra, India

The Orchid School; 🇮🇳 Pune, Maharashtra, India