- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06111651
Family-Based Prevention With Black and Latinx Children
January 21, 2026 updated by: Daniel Cooper, University of South Carolina
Family-Based Prevention to Promote the Social-Emotional Functioning and Healthy Lifestyle Behaviors of Black & Latinx Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Eligible children will:
- be between the ages of 3-6 years
- identify as Black/African American or Latinx/Hispanic
- 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.
Exclusion Criteria:
Consistent with typical methods associated with a universal prevention approach, there are minimal exclusion criteria. Children will be excluded who:
- have a cognitive/psychological condition that limits the child's ability to communicate
- have a physical health condition that limits the child's ability to be physically active
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
parents will participate in a multicomponent parenting intervention
|
parent training program with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors
|
|
No Intervention: Control
parents will receive information about healthy eating habits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
child social-emotional functioning
Time Frame: pre (weeks 0-2) and post intervention (weeks 6-8)
|
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.
|
pre (weeks 0-2) and post intervention (weeks 6-8)
|
|
child physical activity
Time Frame: pre (weeks 0-2) and post intervention (weeks 6-8)
|
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.
|
pre (weeks 0-2) and post intervention (weeks 6-8)
|
|
child sleep
Time Frame: pre (weeks 0-2) and post intervention (weeks 6-8)
|
Child average nightly sleep duration and quality will be calculated from data obtained using a waterproof accelerometer.
|
pre (weeks 0-2) and post intervention (weeks 6-8)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
parenting practices
Time Frame: pre (weeks 0-2) and post intervention (weeks 6-8)
|
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.
|
pre (weeks 0-2) and post intervention (weeks 6-8)
|
|
ethnic-racial socialization practices
Time Frame: pre (weeks 0-2) and post intervention (weeks 6-8)
|
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.
|
pre (weeks 0-2) and post intervention (weeks 6-8)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2024
Primary Completion (Actual)
November 30, 2025
Study Completion (Actual)
January 21, 2026
Study Registration Dates
First Submitted
October 26, 2023
First Submitted That Met QC Criteria
October 26, 2023
First Posted (Actual)
November 1, 2023
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 21, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00124236
- 5P20GM130420 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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