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Clinical Trials/NCT06111651
NCT06111651
Completed
N/A

Family-Based Prevention to Promote the Social-Emotional Functioning and Healthy Lifestyle Behaviors of Black & Latinx Children

University of South Carolina1 site in 1 country80 target enrollmentJune 5, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Behavior
Sponsor
University of South Carolina
Enrollment
80
Locations
1
Primary Endpoint
child physical activity
Status
Completed
Last Updated
3 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
June 5, 2024
End Date
January 21, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Cooper

Assistant Professor

University of South Carolina

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • parenting practices(pre (weeks 0-2) and post intervention (weeks 6-8))
  • ethnic-racial socialization practices(pre (weeks 0-2) and post intervention (weeks 6-8))

Study Sites (1)

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