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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06163703
Other study ID # Pro00123900
Secondary ID 5P20GM130420
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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