Skip to main content
OpenTrials
Completed

NCT Number: NCT06163703

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Child Behavior Behavior Parenting Sedentary Behavior Self-Control Self-regulation Social Behavior

Age range

3 year–9 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

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

Primary outcomes

  1. Intervention acceptability

    Time frame: 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.

  2. Intervention appropriateness

    Time frame: 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.

  3. Intervention feasibility--Implementability

    Time frame: 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.

  4. Intervention feasibility--Attendance

    Time frame: Weekly throughout intervention period (Weeks 1-17)

    Assessed as parent attendance at intervention sessions using weekly attendance logs

  5. Trial-related feasibility--Recruitment capability

    Time frame: Continuously throughout recruitment period, up to 156 weeks

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

  6. Trial-related feasibility--Retention

    Time frame: 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.

  7. Child social-emotional difficulties: Problem behaviors

    Time frame: 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).

  8. Child social-emotional difficulties: Depression and anxiety symptoms

    Time frame: 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).

  9. Child social-emotional difficulties: Strengths and difficulties

    Time frame: 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).

  10. Child physical activity

    Time frame: 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.

  11. Child screen time

    Time frame: 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.

  12. Child sleep

    Time frame: 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 outcomes

  1. Parenting practices

    Time frame: 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.

  2. Parenting self-regulation

    Time frame: 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.

  3. Parenting stress

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Strengthening Child Social-Emotional Functioning and Healthy Lifestyle Behaviors Through Parent-Based Prevention in Families Experiencing Major Stressors

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Jun 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.