An interventional study of Family Life Skills Triple P in Child Behavior, Sedentary Behavior and Self-regulation, sponsored by University of South Carolina. Completed at 1 site in United States. Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by University of South Carolina · Not applicable, Interventional, and Prevention
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.
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.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's enrollment of 86 is below the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parent/caregiver willing to engage in the intervention who
Exclusion Criteria:
a. Parent or child has
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: post-intervention (T2, Weeks 16-18)
Intervention feasibility--Attendance
Assessed as parent attendance at intervention sessions using weekly attendance logs
Time frame: Weekly throughout intervention period (Weeks 1-17)
Trial-related feasibility--Recruitment capability
Assessed as the proportion of eligible children who enroll in the study.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Apr 2026, 26 months.
Of 140 non-industry interventional studies with no phase under Child Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's 26 months is above that.
Counting every sponsor, half of 141 studies reached it within 20 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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