Girls First - India (2013-2015)

Emotional Wellbeing Clinical Trial

Official title:

Girls First - India Evaluation (2013-2015)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429661
• Other study ID #: 01-GF-IN-2013
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: April 24, 2015
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: CorStone
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the social, emotional, physical, and educational effects of Girls First, a combined resilience and adolescent health program, vs. its components and a control group, among adolescents in India.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4592
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 20 Years

Eligibility

Inclusion Criteria:

• Enrolled at schools or present at sites selected for study

• Must complete consent/assent process

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Emotional Wellbeing
• Physical Wellbeing
• Social Wellbeing

Intervention

Behavioral:
• Peer support groups

Locations

Country	Name	City	State
United States	CorStone	Mill Valley	California

Sponsors (4)

Lead Sponsor	Collaborator
CorStone	David & Lucile Packard Foundation, Gramin Evam Nagar Vikas Parishad (GENVP), Integrated Development Foundation (IDF)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosocial assets and wellbeing	Measured by self-report scales	Change from baseline, measured at program completion (average of 6 months)	No
Primary	Physical health and wellbeing	Measured by self-report questions	Change from baseline, measured at program completion (average of 6 months)	No
Secondary	Educational wellbeing	Measured by self-report questions	Change from baseline, measured at program completion (average of 6 months)	No