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Family-Based Prevention With Black and Latinx Children

NCT ID: NCT06111651

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Child Behavior Health Behavior

Keywords

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parent training randomized controlled trial pilot study child development implementation trial prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

parents will participate in a multicomponent parenting intervention

Group Type EXPERIMENTAL

Parenting Intervention

Intervention Type BEHAVIORAL

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

Control

parents will receive information about healthy eating habits

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Parenting Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Daniel Cooper

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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5P20GM130420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00124236

Identifier Type: -

Identifier Source: org_study_id