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Clinical Trials/NCT03982563
NCT03982563
Completed
N/A

Evaluating the Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents

University of Pennsylvania4 sites in 1 country958 target enrollmentJuly 31, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Well-being
Sponsor
University of Pennsylvania
Enrollment
958
Locations
4
Primary Endpoint
Change in The Warwick-Edinburgh Mental Wellbeing Scale
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 31, 2019
End Date
June 4, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Akash Wasil

Graduate Student

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Unable to provide informed consent

Outcomes

Primary Outcomes

Change in The Warwick-Edinburgh Mental Wellbeing Scale

Time Frame: 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

Time Frame: 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 Outcomes

  • 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))
  • Perceived Stress Scale-4(Baseline, 4 week follow-up, 12 week follow-up)

Study Sites (4)

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