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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parenting; Child Behavior; Sedentary Behavior; Self-regulation
• Intervention / Treatment: Behavioral: Family Life Skills Triple P

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada M Goodrum, Ph.D.; Phone Number: 803-576-7809; Email: ngoodrum@mailbox.sc.edu
• Study Contact Backup: Name: Ellen Rebekah Siceloff, Ph.D.; Phone Number: 803-777-7409; Email: sicelofe@mailbox.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • University of South Carolina
      • Contact: Nada Goodrum, Ph.D.; Email: ngoodrum@mailbox.sc.edu
      • Contact: Rebekah Siceloff, Ph.D.; Email: SICELOFE@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in the intervention arm will receive a 12-session parent-based prevention program based on Family Life Skills Triple P.	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.
No Intervention: Waitlist Control; Participants in the waitlist control arm will not receive any intervention during the clinical trial. They will be placed on a waitlist and then offered the intervention once post assessments are complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Intervention feasibility--Attendance	Assessed as parent attendance at intervention sessions using weekly attendance logs	Weekly throughout intervention period (Weeks 1-17)
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
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Nada M Goodrum, Ph.D., University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00123900; 5P20GM130420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No