Girls First - India (2013-2015)

NCT ID: NCT02429661

Last Updated: 2015-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Emotional Wellbeing Social Wellbeing Physical Wellbeing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Peer support groups

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Peer support groups

Intervention Type BEHAVIORAL

RC+HC (Girls First)

Girls First is a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC).

Group Type EXPERIMENTAL

Peer support groups

Intervention Type BEHAVIORAL

SC (School-as-usual control)

Participants receive no intervention and attend school as they usually would.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Peer support groups

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

9 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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David & Lucile Packard Foundation

UNKNOWN

Sponsor Role collaborator

Gramin Evam Nagar Vikas Parishad (GENVP)

UNKNOWN

Sponsor Role collaborator

Integrated Development Foundation Nepal

OTHER

Sponsor Role collaborator

CorStone

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Peabody, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

QURE Healthcare

Locations

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CorStone

Mill Valley, California, United States

Site Status

Countries

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United States

References

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Leventhal KS, DeMaria LM, Gillham J, Andrew G, Peabody JW, Leventhal S. Fostering emotional, social, physical and educational wellbeing in rural India: the methods of a multi-arm randomized controlled trial of Girls First. Trials. 2015 Oct 26;16:481. doi: 10.1186/s13063-015-1008-3.

Reference Type DERIVED
PMID: 26503139 (View on PubMed)

Other Identifiers

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01-GF-IN-2013

Identifier Type: -

Identifier Source: org_study_id

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