Girls First - India (2013-2015)

April 24, 2015 updated by: CorStone

Girls First - India Evaluation (2013-2015)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4592

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mill Valley, California, United States, 94941
        • CorStone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial assets and wellbeing
Time Frame: Change from baseline, measured at program completion (average of 6 months)
Measured by self-report scales
Change from baseline, measured at program completion (average of 6 months)
Physical health and wellbeing
Time Frame: Change from baseline, measured at program completion (average of 6 months)
Measured by self-report questions
Change from baseline, measured at program completion (average of 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Educational wellbeing
Time Frame: Change from baseline, measured at program completion (average of 6 months)
Measured by self-report questions
Change from baseline, measured at program completion (average of 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorStone

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 01-GF-IN-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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