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

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163703
• Other study ID #: Pro00123900
• Secondary ID: 5P20GM130420
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: February 2024
• Source: University of South Carolina
• Contact: Nada M Goodrum, Ph.D.
• Phone: 803-576-7809
• Email: ngoodrum[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Behavior
• Parenting
• Sedentary Behavior
• Self-regulation

Intervention

Behavioral:
• Family Life Skills Triple P
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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Intervention feasibility--Attendance	Assessed as parent attendance at intervention sessions using weekly attendance logs	Weekly throughout intervention period (Weeks 1-17)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Parenting practices	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.	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Secondary	Parenting self-regulation	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.	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Secondary	Parenting stress	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.	baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)