Clinical trial NCT06163703: Strengthening Child Social-Emotional and Lifestyle Health in Families Experiencing Stress
Official title: Strengthening Child Social-Emotional Functioning and Healthy Lifestyle Behaviors Through Parent-Based Prevention in Families Experiencing Major Stressors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior
Sedentary Behavior
Self-regulation
Parenting
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention acceptability
timeFrame: post-intervention (T2, Weeks 16-18)
measure: Intervention appropriateness
timeFrame: post-intervention (T2, Weeks 16-18)
measure: Intervention feasibility--Implementability
timeFrame: post-intervention (T2, Weeks 16-18)
measure: Intervention feasibility--Attendance
timeFrame: Weekly throughout intervention period (Weeks 1-17)
measure: Trial-related feasibility--Recruitment capability
timeFrame: Continuously throughout recruitment period, up to 156 weeks
measure: Trial-related feasibility--Retention
timeFrame: Continuously through study period (Weeks 1-30)
measure: Child social-emotional difficulties: Problem behaviors
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
measure: Child social-emotional difficulties: Depression and anxiety symptoms
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
measure: Child social-emotional difficulties: Strengths and difficulties
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
measure: Child physical activity
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
measure: Child screen time
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
measure: Child sleep
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Secondary outcomes:
measure: Parenting practices
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
measure: Parenting self-regulation
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
measure: Parenting stress
timeFrame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Nada M Goodrum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: