Girls First - India (2013-2015)

• Sponsor: CorStone (Other)
• Overall Status: Completed
• CT.gov ID: NCT02429661
• Collaborator: David & Lucile Packard Foundation (Other), Gramin Evam Nagar Vikas Parishad (GENVP) (Other), Integrated Development Foundation Nepal (Other)
• Enrollment: 4,592
• Location: 1
• Arms: 4
• Duration (Months): 22
• Patients Per Site Per Month: 208.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Emotional Wellbeing; Social Wellbeing; Physical Wellbeing	Behavioral: Peer support groups	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4592 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Girls First - India Evaluation (2013-2015)
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RC (Girls First Resilience Curriculum) The Girls First Resilience Curriculum is delivered in peer support groups of 12-15 students per group over 23 weekly 1-hour sessions. The curriculum draws from fields such as positive psychology, emotional competence/intelligence, and restorative practices, and aims to improve students' psychosocial assets and wellbeing.	Behavioral: Peer support groups
Experimental: HC (Girls First Health Curriculum) The Girls First Health Curriculum is delivered in peer support groups of 12-15 students per group over 21 weekly 1-hour sessions. The curriculum covers topics such as nutrition, sexual and reproductive health, clean water, hygiene, and common diseases, and aims to improve students' physical health and wellbeing.	Behavioral: Peer support groups
Experimental: RC+HC (Girls First) Girls First is a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC).	Behavioral: Peer support groups
No Intervention: SC (School-as-usual control) Participants receive no intervention and attend school as they usually would.

Outcome Measures

Primary Outcome Measures

1. Psychosocial assets and wellbeing [Change from baseline, measured at program completion (average of 6 months)]

   Measured by self-report scales

2. Physical health and wellbeing [Change from baseline, measured at program completion (average of 6 months)]

   Measured by self-report questions

Secondary Outcome Measures

1. Educational wellbeing [Change from baseline, measured at program completion (average of 6 months)]

   Measured by self-report questions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Enrolled at schools or present at sites selected for study

• Must complete consent/assent process

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CorStone	Mill Valley	California	United States	94941

Sponsors and Collaborators

• CorStone
• David & Lucile Packard Foundation
• Gramin Evam Nagar Vikas Parishad (GENVP)
• Integrated Development Foundation Nepal

Investigators

• Principal Investigator: John Peabody, MD, PhD, QURE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CorStone
• ClinicalTrials.gov Identifier: NCT02429661
• Other Study ID Numbers: 01-GF-IN-2013
• First Posted: Apr 29, 2015
• Last Update Posted: Apr 29, 2015
• Last Verified: Apr 1, 2015

Study Results

No Results Posted as of Apr 29, 2015