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Completed

NCT Number: NCT06111651

Family-Based Prevention With Black and Latinx Children

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parenting intervention

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. parenting practices

    Time frame: 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.

  2. ethnic-racial socialization practices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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