Family-Based Prevention With Black and Latinx Children

Sponsor

University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06111651

Collaborator

(none)

Enrollment

Location

Arms

24.1

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Behavior Health Behavior	Behavioral: Parenting Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 30, 2024

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention parents will participate in a multicomponent parenting intervention	Behavioral: 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

Arm

Intervention/Treatment

Experimental: Intervention

parents will participate in a multicomponent parenting intervention

Behavioral: 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

Outcome Measures

Primary Outcome Measures

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 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 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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.