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

University of South Carolina

Status: Enrolling

Conditions: Parenting; Child Behavior; Self-regulation; Sedentary Behavior

Treatments: Behavioral: Family Life Skills Triple P

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06163703

Pro00123900

5P20GM130420 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants in the intervention arm will receive a 12-session parent-based prevention program based on Family Life Skills Triple P.

Treatment:

Behavioral: Family Life Skills Triple P

Waitlist Control

No Intervention group

Description:

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.