Girls First - India (2013-2015)

NCT02429661 | Completed

• 1 other identifier: 01-GF-IN-2013
• Study Type: interventional
• Target: 4,592
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Wellbeing; Social Wellbeing; Physical Wellbeing

Outcome Measures

Primary Outcomes (2)

• Psychosocial assets and wellbeing

  Measured by self-report scales

  Change from baseline, measured at program completion (average of 6 months)

• Physical health and wellbeing

  Measured by self-report questions

  Change from baseline, measured at program completion (average of 6 months)

Secondary Outcomes (1)

• Educational wellbeing

  Change from baseline, measured at program completion (average of 6 months)

Study Arms (4)

RC (Girls First Resilience Curriculum)

EXPERIMENTAL

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

HC (Girls First Health Curriculum)

EXPERIMENTAL

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

RC+HC (Girls First)

EXPERIMENTAL

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

Behavioral: Peer support groups

SC (School-as-usual control)

NO INTERVENTION

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

Interventions

Peer support groups BEHAVIORAL

HC (Girls First Health Curriculum); RC (Girls First Resilience Curriculum); RC+HC (Girls First)

Eligibility Criteria

• Age: 9 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

CorStone

Mill Valley, California, 94941, United States

Location

Related Publications (1)

• 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.

  PMID: 26503139 DERIVED

Study Officials

• John Peabody, MD, PhD

  QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 29, 2015
• Study Start: May 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

US (1)