Family-Based Prevention With Black and Latinx Children

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111651
• Other study ID #: Pro00124236
• Secondary ID: 5P20GM130420
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: June 2024
• Source: University of South Carolina
• Contact: Daniel K Cooper, PhD
• Phone: 803-777-4137
• Email: dc47[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior
• Health Behavior

Intervention

Behavioral:
• Parenting Intervention
parent training program with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre (weeks 0-2) and post intervention (weeks 6-8)
Primary	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.	pre (weeks 0-2) and post intervention (weeks 6-8)
Primary	child sleep	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	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.	pre (weeks 0-2) and post intervention (weeks 6-8)
Secondary	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.	pre (weeks 0-2) and post intervention (weeks 6-8)