Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-27 @ 10:13 AM
Study NCT ID:
NCT06111651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2023-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-Based Prevention With Black and Latinx Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'child social-emotional functioning', 'timeFrame': 'pre (weeks 0-2) and post intervention (weeks 6-8)', 'description': 'Parent-reported assessment of various positive and negative child behaviors. Likert scale values range from 0 to 2, with higher values typically indicating greater dysfunctional behavior.'}, {'measure': 'child physical activity', 'timeFrame': 'pre (weeks 0-2) and post intervention (weeks 6-8)', 'description': 'Time spent sedentary and in light, moderate, and vigorous physical activity each day will be collected using a waterproof accelerometer. Validated methods will be used to identify valid days and derive activity intensities.'}, {'measure': 'child sleep', 'timeFrame': 'pre (weeks 0-2) and post intervention (weeks 6-8)', 'description': 'Child average nightly sleep duration and quality will be calculated from data obtained using a waterproof accelerometer.'}], 'secondaryOutcomes': [{'measure': 'parenting practices', 'timeFrame': 'pre (weeks 0-2) and post intervention (weeks 6-8)', 'description': 'Parent-reported measure of different dimensions of parenting (e.g., harsh parenting, permissive parenting). Likert scale values range from 1 to 7, with higher values indicating greater dysfunctional parenting.'}, {'measure': 'ethnic-racial socialization practices', 'timeFrame': 'pre (weeks 0-2) and post intervention (weeks 6-8)', 'description': 'Parent-reported measure of attitudes about and use of various ethnic-racial socialization practices. Likert scale values range from 1 to 5, with higher values indicating more positive ethnic-racial socialization attitudes and practices.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['parent training', 'randomized controlled trial', 'pilot study', 'child development', 'implementation trial', 'prevention'], 'conditions': ['Child Behavior', 'Health Behavior']}, 'descriptionModule': {'briefSummary': 'The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children.', 'detailedDescription': "This pilot project is novel in that it (a) interweaves positive parenting practices, ethnic-racial socialization, and healthy lifestyle behaviors into a prevention program for Black and Latinx families, and (b) targets preschool-aged children using a brief, universal prevention approach, which increases potential for dissemination and scalability. The guiding hypothesis is that incorporating these components into a parenting intervention will lead to improvements in children's health as compared to a control condition. A type 1 hybrid effectiveness-implementation design is used to simultaneously test intervention effectiveness while also gathering information on intervention delivery to inform future implementation trials. The specific aims are to: (a) test the preliminary effects of a preventive intervention on the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children, (b) identify the preliminary effects of the intervention on parenting outcomes, and (c) examine potential barriers and facilitators to intervention delivery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nEligible children will:\n\n* be between the ages of 3-6 years\n* identify as Black/African American or Latinx/Hispanic\n* have a parent or caregiver willing to participate in the intervention that: (a) lives in the same household as the child ≥50% of the time, (b) has primary responsibility for the child, and (c) speaks English or Spanish.\n\nExclusion Criteria:\n\nConsistent with typical methods associated with a universal prevention approach, there are minimal exclusion criteria. Children will be excluded who:\n\n* have a cognitive/psychological condition that limits the child's ability to communicate\n* have a physical health condition that limits the child's ability to be physically active"}, 'identificationModule': {'nctId': 'NCT06111651', 'briefTitle': 'Family-Based Prevention With Black and Latinx Children', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Family-Based Prevention to Promote the Social-Emotional Functioning and Healthy Lifestyle Behaviors of Black & Latinx Children', 'orgStudyIdInfo': {'id': 'Pro00124236'}, 'secondaryIdInfos': [{'id': '5P20GM130420', 'link': 'https://reporter.nih.gov/quickSearch/5P20GM130420', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'parents will participate in a multicomponent parenting intervention', 'interventionNames': ['Behavioral: Parenting Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'parents will receive information about healthy eating habits'}], 'interventions': [{'name': 'Parenting Intervention', 'type': 'BEHAVIORAL', 'description': 'parent training program with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Daniel Cooper', 'investigatorAffiliation': 'University of South Carolina'}}}}