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CompletedNCT06111651Updated Jan 22, 2026

Family-Based Prevention With Black and Latinx Children

An interventional study of Parenting Intervention in Child Behavior and Health Behavior, sponsored by University of South Carolina. Completed at 1 site in United States. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by University of South Carolina · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Child Behavior
  • Health Behavior

Keywords

  • parent training
  • randomized controlled trial
  • pilot study
  • child development
  • implementation trial
  • prevention
03

In context

Child Behavior

224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.

This study's enrollment of 80 is below the median of 140 across 197 interventional studies indexed under Child Behavior.

Browse Child Behavior studies →

Lead sponsor

University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Intervention

    parents will participate in a multicomponent parenting intervention

    Behavioral: Parenting Intervention

  • No intervention
    Control

    parents will receive information about healthy eating habits

Interventions

  • BehavioralParenting Intervention

    parent training program with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors

06

What researchers measure

Primary outcomes

  1. child social-emotional functioning

    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.

    Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)

  2. child physical activity

    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.

    Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)

  3. child sleep

    Child average nightly sleep duration and quality will be calculated from data obtained using a waterproof accelerometer.

    Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)

Secondary outcomes

  1. parenting practices

    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.

    Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)

  2. ethnic-racial socialization practices

    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.

    Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)

07

Study locations

1 site
  • University of South Carolina
    Columbia, South Carolina 29208, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06111651
Responsible party
Daniel Cooper (Assistant Professor, University of South Carolina) — Principal investigator
First posted
Nov 1, 2023
Start date
Jun 5, 2024
Primary completion
Nov 30, 2025
Completion
Jan 21, 2026
Last update
Jan 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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