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Clinical Trials/NCT06163703
NCT06163703
Active, Not Recruiting
N/A

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

University of South Carolina1 site in 1 country60 target enrollmentFebruary 9, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Behavior
Sponsor
University of South Carolina
Enrollment
60
Locations
1
Primary Endpoint
Intervention feasibility--Attendance
Status
Active, Not Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 9, 2024
End Date
May 31, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nada Goodrum

Assistant Professor

University of South Carolina

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Intervention feasibility--Attendance

Time Frame: 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

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).

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.

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.

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).

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.

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.

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.

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.

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.

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).

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

  • Parenting self-regulation(baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30))
  • Parenting practices(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 Sites (1)

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