Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-06-15 @ 6:51 PM
Study NCT ID:
NCT03651050
Status:
COMPLETED
Last Update Posted:
2021-12-09
First Post:
2018-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003150', 'term': 'Community Health Workers'}], 'ancestors': [{'id': 'D000488', 'term': 'Allied Health Personnel'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aggression measured by parent report', 'timeFrame': '24 Months'}, {'measure': 'Anxiety measured by parent report', 'timeFrame': '24 Months'}, {'measure': 'Depression measured by parent report', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health']}, 'descriptionModule': {'briefSummary': 'The proposed project is to develop a Pediatric-Mental Health Digital Toolkit (P-MHDT) Toolkit to support innovative child mental health preventive interventions in FBO settings. This project focuses on developing a P-MHDT and carrying out a pilot feasibility evaluation in real world settings. A group of Mental Health Professionals (MHPs)/ Community Healthcare Workers (CHWs) will be trained and the P-MHDT Toolkit intervention will be tested in 6 Faith Based Organizations (FBOs) in Uganda.', 'detailedDescription': "The specific aims of this proposed study include:\n\nAim 1. To develop a P-MHDT (by employing qualitative focus-group interviews and user-centered design to enhance usability).\n\nAim 2. To train mental health professionals and community health workers (CHWs) for the P-MHDT approach of child mental health promotion in Uganda (including monitoring impacts of training on CHWs' program implementation competency).\n\nAim 3 (11-24 month). To estimate impacts of the P-MHDT on FBOs and families (i.e., caregivers' mental health literacy, practices, and children's mental health) when implemented in the real world FBO settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be at least 18 years of age. Participating parents must be caregivers of age 1-7 years old children.\n* Children are not the subjects of this study, and will not participate in research activities.\n\nExclusion Criteria:\n\n* Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.\n* Minors (age \\<18) will also be excluded.'}, 'identificationModule': {'nctId': 'NCT03651050', 'briefTitle': 'Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings', 'orgStudyIdInfo': {'id': '18-00728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention FBOs receive the P-MHDT', 'interventionNames': ['Behavioral: Faith Based Outreach (FBO)']}, {'type': 'EXPERIMENTAL', 'label': 'control FBOs receive no P-MHDT', 'interventionNames': ['Behavioral: community-health-workers (CHW)']}], 'interventions': [{'name': 'Faith Based Outreach (FBO)', 'type': 'BEHAVIORAL', 'description': 'Faith base outreach groups will be trained in P-MHDT', 'armGroupLabels': ['intervention FBOs receive the P-MHDT']}, {'name': 'community-health-workers (CHW)', 'type': 'BEHAVIORAL', 'description': 'COmmon health workers will be trained in P-MHDT', 'armGroupLabels': ['control FBOs receive no P-MHDT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Keng-Yen Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}