Targeting Behavioral Adjustment and Healthy Lifestyle in Preschool-age Children Using an Integrated Family-Based Intervention
Phase: NA
Conditions: Child Behavior, Child Health, Child, Preschool, Parents
Sponsor: University of South Carolina

Study Protocol and Statistical Plan 
 
Project Title: The Healthy Child Development Program Study 
 
NCT04622969 
 
Document Date: January 15, 2025 (Updated April 16, 2025) 
 
 
 

Study Protocol 
Scientific Background 
 
Children’s behavioral and emotional problems, on the one hand, and childhood 
obesogenic lifestyle related behaviors on the other, each heighten risk for adverse health 
outcomes such as depression, substance use disorders, and obesity in adolescence, and suicidality 
and diabetes in adulthood. Prevention in both child domains is warranted. At school entry, many 
children encounter difficulties because of social, emotional, and behavioral (SEB) problems, 
which can co-occur with, and be complicated by, unhealthy lifestyles such as low physical 
activity, excessive screen time, and inadequate sleep. Even though both domains are critical to 
child development, most of the research on preventive interventions with young children has 
focused on either one domain or the other, but seldom both.  
 
There is a clear need for family-based interventions that integrate the two domains 
because parents exert major influence on both SEB functioning and healthy lifestyle. With 
preschool age children, addressing parenting and family environment represents one of the 
stronger modes of intervention. Preschoolers spend a lot of time at home. Their early behaviors 
can set lifelong patterns of social interaction, cooperative and self-regulated behavior, physical 
activity, and sedentary and screen time habits. 
 
Drawing on referrals of high-risk families from multiple community organizations, this 
study seeks to address both SEB and health domains through a family-based intervention. Young 
children living in economically disadvantaged circumstances experience elevated risk for SEB 
problems and obesogenic behaviors. The dual focus is on family-based intervention to improve 
young children’s SEB adjustment and to promote healthy lifestyle behaviors (i.e., physical 
activity, reduced screen time, and adequate sleep). The integration of the two target domains in 
the intervention is viable because both are impacted through parenting, strengthening of the 
parent-child relationship, and home routines. In addition, preschoolers’ physical activity, screen 
time, and sleep patterns can directly impact their SEB adjustment. For example, hyperactivity 
and inattention (i.e., two behavioral concerns common in young children) can be exacerbated by 
insufficient sleep and excessive screen time. Addressing these multiple concerns in young 
children has the potential to launch positive trajectories and reduce the likelihood of long-term 
adverse behavioral and health outcomes. 
 
The research project focuses on intervention with high-risk families and preschoolers. 
The high-risk population selected for the project consists of economically disadvantaged families 
who are experiencing parenting challenges due to child behavior concerns, with referrals by 
agency or organization staff reflecting that the child and family need preventive services. The 
home-delivered prevention intervention being tested includes content on strengthening positive 
behaviors in children, managing misbehavior, and addressing healthy lifestyle choices. Families 
participating in the intervention will be engaged in practical skill building (e.g., behavioral 
teaching; planned activities training) and will have the opportunity to practice these skills and 
receive feedback. 
Objectives 
The study was designed to collect data ultimately to inform decisions about the design of a future 
well-powered R01-magnitude prevention clinical trial, pursuing these objectives: 
Objective 1: Examine preliminary impact of the intervention on primary outcomes for child 
behavior problems and child physical activity, compared with the control condition. 
Objective 2: Examine preliminary impact of the intervention on primary outcomes for child 
screen time and child sleep duration, compared with the control condition. 

Objective 3: Examine preliminary impact of the intervention on secondary outcomes for 
parenting difficulties, parental stress, and parental confidence, compared with the control 
condition. 
Design 
 
The project involves preliminary evaluation of a family-based intervention that seeks to 
improve preschool children’s SEB adjustment as well as promote healthy lifestyle behaviors (i.e., 
physical activity, reduced screen time, adequate sleep, and positive eating habits). The sample 
consists of high-risk families referred for prevention-based family services (i.e., differential 
response services) or receiving health services from a low-income-focused community 
healthcare center. Parents will receive in-home parenting education and coaching from 
intervention staff on how to use positive parenting strategies to strengthen child behavior, reduce 
screen time, increase moderate and vigorous physical activity, improve sleep duration, and 
promote healthy eating habits. The design involves randomization of families in equal proportion 
to either intervention or wait-list control conditions. The goal is to recruit at least 60 famlies for 
the study. Assessment of outcome measures were set to be conducted at baseline and six months 
after baseline (i.e., pre, post). Randomization was set to occur after completion of the consent 
process and baseline assessment.  
Methods 
Recruitment of prospective participants focuses on referrals from numerous community 
organizations and agencies serving families and young children. 
The implementation plan is for the intervention to be delivered by trained staff and conducted in 
the homes of the participating families. The intervention takes 15 weekly sessions to cover the 
content.  
For the measurement plan, assessments for all outcome measures take place at baseline and then 
six months after baseline.  
 
Statistical Plan 
 
For each of the outcome variables, the intervention and control groups will be compared 
on post-intervention outcome adjusting for baseline (preintervention) as a covariate. All outcome 
analyses will adopt an intent-to-treat approach. The analytic method will be ANCOVA, with 
estimation of the model based on bootstrapped standard errors to address any potential non-
linearity in the outcome variable. The study is meant to conduct a preliminary examination of the 
potential impact of the family-based intervention on both the primary and secondary outcomes. 
As needed where appropriate, linear mixed-models analysis will be conducted in place of 
ANCOVA.