Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-27 @ 3:24 AM
Study NCT ID:
NCT06065293
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Health, Gender-Based Violence, and Stunting in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression and anxiety', 'timeFrame': 'Through study completion, approximately 2 months', 'description': 'Hopkins Symptom Checklist'}, {'measure': 'Substance use', 'timeFrame': 'Through study completion, approximately 2 months', 'description': 'Alcohol Use Disorders Identification Test (AUDIT)'}, {'measure': 'World Health Organization (WHO) Violence Against Women', 'timeFrame': 'Through study completion, approximately 2 months', 'description': 'WHO Violence Against Women'}, {'measure': 'Childhood stunting', 'timeFrame': 'Through study completion, approximately 2 months', 'description': 'Height, weight, and head circumference of child under 2.5 years old'}], 'secondaryOutcomes': [{'measure': "Women's Empowerment", 'timeFrame': 'Through study completion, approximately 2 months', 'description': "Women's Empowerment measure"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health Issue', 'Substance Use', 'Child Development']}, 'descriptionModule': {'briefSummary': "One in three children under the age of five in Tanzania experience stunting, which is defined as impairments in growth and development that often occur after poor nutrition, poor health, and low psychosocial stimulation. Research suggests that mental health problems of parents may be related to stunting outcomes and parental mental health is closely related to experiences of intimate partner violence, also called gender-based violence. However, very little research exists on the connection between these elements, and interventions may be necessary in order to reduce the impacts that mental health and gender-based violence may have on stunting.\n\nThis study is a secondary data analysis of de-identified survey and stunting data that were conducted as a part of a needs assessment by a local nonprofit organization in Tanzania. The needs assessment was conducted to inform a mental health initiative organized by the established nonprofit across 5 villages in rural Tanzania. This project's primary aims are:\n\n* To determine the prevalence of mental health and family relationship problems in five villages\n* To determine associations between intimate partner violence (IPV) mental health and substance use and childhood stunting"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '162 mothers participating in a local non-profit organization in Tanzania', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living within the 5 rural villages\n* participating in a local nonprofit\n* pregnant or having a child under 2 years old\n\nExclusion Criteria:\n\n* Living outside of the 5 villages\n* Not participating in the local nonprofit\n* Not pregnant or having a child under 2 years old'}, 'identificationModule': {'nctId': 'NCT06065293', 'briefTitle': 'Mental Health, Gender-Based Violence, and Stunting in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Colorado State University'}, 'officialTitle': 'Establishing a Community-led, Family-centered Mental Wellness Initiative in Rural Tanzania', 'orgStudyIdInfo': {'id': '3916'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mothers involved in a local non-profit'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80537', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado State University', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}], 'overallOfficials': [{'name': 'Shelley Haddock, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data are de-identified and there is no plan to make it available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}