Strengthening Child Social-Emotional and Lifestyle Health in Families Experiencing Stress

NCT06163703 | Active Not Recruiting

• 2 other identifiers: Pro001239005P20GM130420
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.

Conditions

Sedentary Behavior; Self-regulation; Parenting; Child Behavior

Outcome Measures

Primary Outcomes (12)

• Intervention acceptability

  Assessed as parent-reported liking and approval of the intervention on a 5-point response scale and satisfaction with the intervention on a 4-point response scale, with higher scores indicating greater acceptability.

  post-intervention (T2, Weeks 16-18)

• Intervention appropriateness

  Assessed as parent-reported applicability and suitability of the intervention on a 5-point response scale, with higher scores indicating greater appropriateness.

  post-intervention (T2, Weeks 16-18)

• Intervention feasibility--Implementability

  Assessed as parent-reported ease of use and overall implementability of the intervention on a 5-point response scale, with higher scores indicating greater feasibility.

  post-intervention (T2, Weeks 16-18)

• Intervention feasibility--Attendance

  Assessed as parent attendance at intervention sessions using weekly attendance logs

  Weekly throughout intervention period (Weeks 1-17)

• Trial-related feasibility--Recruitment capability

  Assessed as the proportion of eligible children who enroll in the study.

  Continuously throughout recruitment period, up to 156 weeks

• Trial-related feasibility--Retention

  Assessed as the proportion of enrolled children who remain in the study through the length of the intervention, with proportion who dropout and reasons for dropout also collected.

  Continuously through study period (Weeks 1-30)

• Child social-emotional difficulties: Problem behaviors

  Assessed as parent-reported frequency of child problematic behaviors on a 7-point response scale (higher scores indicate greater frequency).

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

• Child social-emotional difficulties: Depression and anxiety symptoms

  Assessed as parent-reported frequency of child depression and anxiety symptoms on a 4-point response scale (higher scores indicate greater frequency).

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

• Child social-emotional difficulties: Strengths and difficulties

  Assessed as parent-reported agreement with statements about child strengths and difficulties on a 3-point response scale (higher scores indicate greater endorsement).

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

• Child physical activity

  Assessed as daily time spent sedentary and in various activity intensities using a wrist-worn accelerometer.

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

• Child screen time

  Assessed as parent-reported average daily time spent engaging in screen time, including: watching TV; using a computer; gaming on a console or hand-held device; and using a tablet or smart phone for activities such as viewing videos, playing games, and browsing the internet.

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

• Child sleep

  Assessed using a wrist-worn accelerometer to calculate nighttime sleep duration and using a validated measure of parent-reported child sleep-wake behaviors on a 6-point response scale, with lower scores indicating more problematic behaviors.

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

Secondary Outcomes (3)

• Parenting practices

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

• Parenting self-regulation

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

• Parenting stress

  baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention arm will receive a 12-session parent-based prevention program based on Family Life Skills Triple P.

Behavioral: Family Life Skills Triple P

Waitlist Control

NO INTERVENTION

Participants in the waitlist control arm will not receive any intervention during the clinical trial. They will be placed on a waitlist and then offered the intervention once post assessments are complete.

Interventions

Family Life Skills Triple P BEHAVIORAL

The intervention is a 12-session program that combines parenting support with trauma-informed life skills coaching. It includes content related to positive parenting strategies, self-regulation, coping with emotions, effective communication, dealing with the past, and developing healthy habits.

Intervention

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child between the ages of 3-9 years
• Parent/caregiver willing to engage in the intervention who
• is at least 18 years of age
• is primary caregiver or guardian for the participating child
• has concerns about the child's mood, behavior, and/or lifestyle health
• is experiencing two or more major stressors of the following: trauma history, mental health difficulties, living with HIV, racial discrimination, substance misuse, and/or financial strain
• is English speaking.

You may not qualify if:

• a. Parent or child has
• a significant cognitive disability, developmental delay, or pervasive developmental disorder
• active suicidal or homicidal ideation
• psychotic symptoms (active hallucinations, delusions, or impaired thought processes)
• ongoing family violence occurring within the home and/or active involvement of child protect services related to child maltreatment allegations.

Sponsors & Collaborators

• University of South Carolina: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Child Behavior; Sedentary Behavior; Self-Control

Condition Hierarchy (Ancestors)

Behavior; Social Behavior

Study Officials

• Nada M Goodrum, Ph.D.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

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: November 22, 2023
• First Posted: December 11, 2023
• Study Start: February 9, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)