Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression; Anxiety; Well-Being
• Intervention / Treatment: Behavioral: Growth, Gratitude, & Positive Activities; Behavioral: Study Skills Control

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India
      • Z P school, Wablewadi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Growth, Gratitude, & Positive Activities; 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).
Sham Comparator: Study Skills Control	Behavioral: Study Skills Control; Reading and writing activities designed to teach evidence-based study strategies.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Sangath
• Investigators: Study Director: Rob DeRubeis, PhD, University of Pennsylvania; Study Director: Sachin Shinde, PhD, Sangath; Study Director: Sadhana Natu, PhD, Modern College Pune

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 30927492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No