Computerized Single-Session Interventions for Indian Adolescents

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03982563
Collaborator
Sangath (Other)
958
4
4
10.2
239.5
23.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Growth Mindset
  • Behavioral: Gratitude
  • Behavioral: Behavioral Activation
  • Behavioral: Study Skills
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
958 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Evaluating the Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents
Actual Study Start Date :
Jul 31, 2019
Actual Primary Completion Date :
Mar 15, 2020
Actual Study Completion Date :
Jun 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Growth Mindset

Behavioral: Growth Mindset
Reading and writing activities designed to instill the belief that people can change.

Experimental: Gratitude

Behavioral: Gratitude
Reading and writing activities designed to practice noticing and appreciating good things in life.

Experimental: Behavioral Activation

Behavioral: Behavioral Activation
Reading and writing activities designed to identify and schedule positive activities.

Sham Comparator: Study Skills

Behavioral: Study Skills
Reading and writing activities designed to learn evidence-based study strategies.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Attending a participating secondary school

  • Age 12 to 18

  • Literate in English

Exclusion Criteria:
  • Unable to provide informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Kalmadi Junior High School Pune Maharashtra India
2 The Orchid School Pune Maharashtra India
3 JM Rathi English School Roha Maharashtra India
4 Modern College Pune Pune India

Sponsors and Collaborators

  • University of Pennsylvania
  • Sangath

Investigators

  • Study Director: Rob DeRubeis, PhD, University of Pennsylvania
  • Study Director: Sachin Shinde, PhD, Sangath
  • Study Director: Sadhana Natu, PhD, Modern College Pune
  • Principal Investigator: Akash Wasil, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Akash Wasil, Graduate Student, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03982563
Other Study ID Numbers:
  • 24922
First Posted:
Jun 11, 2019
Last Update Posted:
Jun 29, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2020