Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents

Depression Clinical Trial

Official title:

Evaluating the Effectiveness of a Computerized, School-Based, Single-Session Intervention for Rural Indian Adolescents

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04020549
• Other study ID #: 30927492
• Status: Withdrawn
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: June 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Attending a participating secondary school

• Age 12 to 18

• Literate in English

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Anxiety
• Depression
• Well-Being

Intervention

Behavioral:
• Growth, Gratitude, & Positive Activities
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).
• Study Skills Control
Reading and writing activities designed to teach evidence-based study strategies.

Locations

Country	Name	City	State
India	Z P school, Wablewadi	Pune	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Sangath

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.	Baseline, 4 week follow-up, 12 week follow-up
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Perceived Stress Scale-4	Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome.	Time Frame: Baseline, 4 week follow-up, 12 week follow-up