Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents

NCT04020549 | Withdrawn

• 1 other identifier: 30927492
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-Being; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Patient Health Questionnaire-9

  Baseline, 4 week follow-up, 12 week follow-up

• Generalized Anxiety Disorder Screener-7

  Baseline, 4 week follow-up, 12 week follow-up

• The EPOCH Measure of Adolescent Well-being

  Baseline, 4 week follow-up, 12 week follow-up

• Acceptability of Intervention Measure

  Immediately post-intervention (i.e., 0 weeks)

• Feasibility of Intervention Measure

  Immediately post-intervention (i.e., 0 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Growth, Gratitude, & Positive Activities

Study Skills Control

SHAM COMPARATOR

Behavioral: Study Skills Control

Interventions

Growth, Gratitude, & Positive Activities BEHAVIORAL

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).

Intervention

Study Skills Control BEHAVIORAL

Reading and writing activities designed to teach evidence-based study strategies.

Study Skills Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• University of Pennsylvania: lead
• Sangath: collaborator

Study Sites (1)

Z P school, Wablewadi

Pune, Maharashtra, India

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Growth

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Rob DeRubeis, PhD

  University of Pennsylvania

  STUDY DIRECTOR

• Sachin Shinde, PhD

  Sangath

  STUDY DIRECTOR

• Sadhana Natu, PhD

  Modern College Pune

  STUDY DIRECTOR

• Akash Wasil

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: July 31, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)