Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT02429661
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2015-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Girls First - India (2013-2015)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4592}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-24', 'studyFirstSubmitDate': '2015-04-22', 'studyFirstSubmitQcDate': '2015-04-24', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychosocial assets and wellbeing', 'timeFrame': 'Change from baseline, measured at program completion (average of 6 months)', 'description': 'Measured by self-report scales'}, {'measure': 'Physical health and wellbeing', 'timeFrame': 'Change from baseline, measured at program completion (average of 6 months)', 'description': 'Measured by self-report questions'}], 'secondaryOutcomes': [{'measure': 'Educational wellbeing', 'timeFrame': 'Change from baseline, measured at program completion (average of 6 months)', 'description': 'Measured by self-report questions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Emotional Wellbeing', 'Social Wellbeing', 'Physical Wellbeing']}, 'referencesModule': {'references': [{'pmid': '26503139', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled at schools or present at sites selected for study\n* Must complete consent/assent process\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02429661', 'briefTitle': 'Girls First - India (2013-2015)', 'organization': {'class': 'OTHER', 'fullName': 'CorStone'}, 'officialTitle': 'Girls First - India Evaluation (2013-2015)', 'orgStudyIdInfo': {'id': '01-GF-IN-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RC (Girls First Resilience Curriculum)', 'description': "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.", 'interventionNames': ['Behavioral: Peer support groups']}, {'type': 'EXPERIMENTAL', 'label': 'HC (Girls First Health Curriculum)', 'description': "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.", 'interventionNames': ['Behavioral: Peer support groups']}, {'type': 'EXPERIMENTAL', 'label': 'RC+HC (Girls First)', 'description': 'Girls First is a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC).', 'interventionNames': ['Behavioral: Peer support groups']}, {'type': 'NO_INTERVENTION', 'label': 'SC (School-as-usual control)', 'description': 'Participants receive no intervention and attend school as they usually would.'}], 'interventions': [{'name': 'Peer support groups', 'type': 'BEHAVIORAL', 'armGroupLabels': ['HC (Girls First Health Curriculum)', 'RC (Girls First Resilience Curriculum)', 'RC+HC (Girls First)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94941', 'city': 'Mill Valley', 'state': 'California', 'country': 'United States', 'facility': 'CorStone', 'geoPoint': {'lat': 37.90604, 'lon': -122.54498}}], 'overallOfficials': [{'name': 'John Peabody, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QURE Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CorStone', 'class': 'OTHER'}, 'collaborators': [{'name': 'David & Lucile Packard Foundation', 'class': 'UNKNOWN'}, {'name': 'Gramin Evam Nagar Vikas Parishad (GENVP)', 'class': 'UNKNOWN'}, {'name': 'Integrated Development Foundation Nepal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}