NCT06111651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

June 5, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

October 26, 2023

Last Update Submit

January 21, 2026

Conditions

Keywords

parent trainingrandomized controlled trialpilot studychild developmentimplementation trialprevention

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • parenting practices

    pre (weeks 0-2) and post intervention (weeks 6-8)

  • ethnic-racial socialization practices

    pre (weeks 0-2) and post intervention (weeks 6-8)

Study Arms (2)

Intervention

EXPERIMENTAL

parents will participate in a multicomponent parenting intervention

Behavioral: Parenting Intervention

Control

NO INTERVENTION

parents will receive information about healthy eating habits

Interventions

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

Intervention

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Child BehaviorHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

June 5, 2024

Primary Completion

November 30, 2025

Study Completion

January 21, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations