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Trial record 1 of 1 for:    NCT02429661
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Girls First - India (2013-2015)

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ClinicalTrials.gov Identifier: NCT02429661
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Collaborators:
David & Lucile Packard Foundation
Gramin Evam Nagar Vikas Parishad (GENVP)
Integrated Development Foundation Nepal
Information provided by (Responsible Party):
CorStone

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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.



Primary Outcome Measures :
  1. Psychosocial assets and wellbeing [ Time Frame: Change from baseline, measured at program completion (average of 6 months) ]
    Measured by self-report scales

  2. Physical health and wellbeing [ Time Frame: Change from baseline, measured at program completion (average of 6 months) ]
    Measured by self-report questions


Secondary Outcome Measures :
  1. Educational wellbeing [ Time Frame: Change from baseline, measured at program completion (average of 6 months) ]
    Measured by self-report questions



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Ages Eligible for Study:   9 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled at schools or present at sites selected for study
  • Must complete consent/assent process

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429661


Locations
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United States, California
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
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Principal Investigator: John Peabody, MD, PhD QURE Healthcare
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CorStone
ClinicalTrials.gov Identifier: NCT02429661    
Other Study ID Numbers: 01-GF-IN-2013
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015