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

Not Applicable

Recruiting

• Conditions: Child Behavior; Sedentary Behavior; Self-regulation; Parenting
• Interventions: Behavioral: Family Life Skills Triple P

• Registration Number: NCT06163703
• Lead Sponsor: University of South Carolina

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.

Detailed Description

Social-emotional difficulties and unhealthy lifestyle behaviors are prevalent among children in the U.S. and are associated with negative health outcomes. These challenges are even more pronounced among families who deal with major stressors, such as parental trauma history and mental health difficulties, parental chronic illness (e.g., HIV), parental substance use, economic disadvantage, and racial discrimination. The purpose of this study is to assess the feasibility, acceptability, and preliminary efficacy of a parent-based preventive intervention targeting parental self-regulation, stress reduction, and positive parenting, to promote child social-emotional and lifestyle behavior health, among families where the parents (a) have a child aged 3 to 9 years old, (b) have concerns about their child's behavior, mood, and/or lifestyle health, and (c) are experiencing major stressors. The intervention to be tested is based on Family Life Skills Triple P.

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-11
• Study Start: 2024-02-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Child between the ages of 3-9 years

2. 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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intervention feasibility--Attendance	Weekly throughout intervention period (Weeks 1-17)	Assessed as parent attendance at intervention sessions using weekly attendance logs
Child social-emotional difficulties: Strengths and difficulties	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	Assessed as parent-reported agreement with statements about child strengths and difficulties on a 3-point response scale (higher scores indicate greater endorsement).
Trial-related feasibility--Recruitment capability	Continuously throughout recruitment period, up to 156 weeks	Assessed as the proportion of eligible children who enroll in the study.
Trial-related feasibility--Retention	Continuously through study period (Weeks 1-30)	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.
Child social-emotional difficulties: Problem behaviors	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	Assessed as parent-reported frequency of child problematic behaviors on a 7-point response scale (higher scores indicate greater frequency).
Child physical activity	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	Assessed as daily time spent sedentary and in various activity intensities using a wrist-worn accelerometer.
Child screen time	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	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.
Intervention appropriateness	post-intervention (T2, Weeks 16-18)	Assessed as parent-reported applicability and suitability of the intervention on a 5-point response scale, with higher scores indicating greater appropriateness.
Intervention acceptability	post-intervention (T2, Weeks 16-18)	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.
Intervention feasibility--Implementability	post-intervention (T2, Weeks 16-18)	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.
Child social-emotional difficulties: Depression and anxiety symptoms	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	Assessed as parent-reported frequency of child depression and anxiety symptoms on a 4-point response scale (higher scores indicate greater frequency).
Child sleep	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	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.

Secondary Outcome Measures

Name	Time	Method
Parenting self-regulation	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	Assessed as parent self-rated agreement with statements about self-regulation as a parent on a 7-point response scale, with higher scores indicating greater self-regulation.
Parenting practices	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	Assessed as parent self-reported frequency of positive and negative parenting behaviors on a 5-point response scale, with higher subscale scores indicating greater frequency of the respective behaviors.
Parenting stress	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)	Assessed as parent self-rated frequency and intensity of daily parenting hassles on a 4--point response scale, with higher scores indicating more frequent and intense hassles.

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States