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Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents

Primary Purpose

Well-Being, Depression, Anxiety

Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Growth, Gratitude, & Positive Activities
Study Skills Control
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Well-Being

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide informed consent

Sites / Locations

  • Z P school, Wablewadi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Study Skills Control

Arm Description

Outcomes

Primary Outcome Measures

Change in The Warwick-Edinburgh Mental Wellbeing Scale
Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.
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.

Secondary Outcome Measures

Patient Health Questionnaire-9
Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.
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.
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.
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.
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.
Perceived Stress Scale-4
Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.

Full Information

First Posted
July 12, 2019
Last Updated
June 26, 2020
Sponsor
University of Pennsylvania
Collaborators
Sangath
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1. Study Identification

Unique Protocol Identification Number
NCT04020549
Brief Title
Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents
Official Title
Evaluating the Effectiveness of a Computerized, School-Based, Single-Session Intervention for Rural Indian Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
In collaboration with community partners, we determined that the reading level required for the intervention did not make it suitable for the adolescents.
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Sangath

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Well-Being, Depression, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Study Skills Control
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Growth, Gratitude, & Positive Activities
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Study Skills Control
Intervention Description
Reading and writing activities designed to teach evidence-based study strategies.
Primary Outcome Measure Information:
Title
Change in The Warwick-Edinburgh Mental Wellbeing Scale
Description
Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.
Time Frame
Baseline, 4 week follow-up, 12 week follow-up
Title
Intervention Appropriateness Measure
Description
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.
Time Frame
Immediately post-intervention (i.e., 0 weeks)
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Description
Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.
Time Frame
Baseline, 4 week follow-up, 12 week follow-up
Title
Generalized Anxiety Disorder Screener-7
Description
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.
Time Frame
Baseline, 4 week follow-up, 12 week follow-up
Title
The EPOCH Measure of Adolescent Well-being
Description
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.
Time Frame
Baseline, 4 week follow-up, 12 week follow-up
Title
Acceptability of Intervention Measure
Description
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.
Time Frame
Immediately post-intervention (i.e., 0 weeks)
Title
Feasibility of Intervention Measure
Description
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.
Time Frame
Immediately post-intervention (i.e., 0 weeks)
Title
Perceived Stress Scale-4
Description
Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.
Time Frame
Time Frame: Baseline, 4 week follow-up, 12 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Attending a participating secondary school Age 12 to 18 Literate in English Exclusion Criteria: Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob DeRubeis, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sachin Shinde, PhD
Organizational Affiliation
Sangath
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sadhana Natu, PhD
Organizational Affiliation
Modern College Pune
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Akash Wasil
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Z P school, Wablewadi
City
Pune
State/Province
Maharashtra
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents

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