Computerized Single-Session Interventions for Indian Adolescents

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Well-being
• Intervention / Treatment: Behavioral: Growth Mindset; Behavioral: Gratitude; Behavioral: Behavioral Activation; Behavioral: Study Skills

• Study Type: Interventional
• Enrollment (Actual): 958
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Pune, India
    • Modern College Pune
  • Maharashtra
    • Pune, Maharashtra, India
      • Dr. Kalmadi Junior High School
    • Pune, Maharashtra, India
      • The Orchid School
    • Roha, Maharashtra, India
      • JM Rathi English School

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation	Behavioral: Behavioral Activation; Reading and writing activities designed to identify and schedule positive activities.
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.
Sham Comparator: Study Skills	Behavioral: Study Skills; Reading and writing activities designed to learn 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
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)
Generalized Anxiety Disorder Screener-7	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
Perceived Stress Scale-4	Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.	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

Publications and helpful links

General Publications

• Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.
• Schleider J, Weisz J. A single-session growth mindset intervention for adolescent anxiety and depression: 9-month outcomes of a randomized trial. J Child Psychol Psychiatry. 2018 Feb;59(2):160-170. doi: 10.1111/jcpp.12811. Epub 2017 Sep 18.
• Emmons RA, McCullough ME. Counting blessings versus burdens: an experimental investigation of gratitude and subjective well-being in daily life. J Pers Soc Psychol. 2003 Feb;84(2):377-89. doi: 10.1037//0022-3514.84.2.377.
• Chorpita BF, Becker KD, Daleiden EL. Understanding the common elements of evidence-based practice: misconceptions and clinical examples. J Am Acad Child Adolesc Psychiatry. 2007 May;46(5):647-52. doi: 10.1097/chi.0b013e318033ff71. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): June 4, 2020

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 24922

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