Family-Based Prevention With Black and Latinx Children

Not Applicable

Recruiting

• Conditions: Health Behavior; Child Behavior
• Interventions: Behavioral: Parenting Intervention

• Registration Number: NCT06111651
• Lead Sponsor: University of South Carolina

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.

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-11-01
• Status Verified: 2024-06
• Study Start: 2024-06-05
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-06-30
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Parenting Intervention	parents will participate in a multicomponent parenting intervention

Primary Outcome Measures

Name	Time	Method
child physical activity	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	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	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 Outcome Measures

Name	Time	Method
parenting practices	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.
ethnic-racial socialization practices	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.

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States