The Healthy Child Development Program Study

Targeting Behavioral Adjustment and Healthy Lifestyle in Preschool-age Children Using an Integrated Family-Based Intervention

This study conducts a preliminary test of an intervention program delivered in the home to assist families of preschool-age children with social, emotional, and behavioral development, and the acquisition of healthy lifestyle behaviors.

Study Overview

• Status: Completed
• Conditions: Parents; Child Behavior; Child Health; Child, Preschool
• Intervention / Treatment: Behavioral: Healthy Child Development Program

Detailed Description

Utilizing referrals from community-based organizations serving high-risk families, this study addresses both health and behavioral domains through a family-based intervention. The home-delivered prevention intervention includes content on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices. Families engage in practical skill building and have the opportunity to practice these skills and receive feedback.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• parent has primary custody of the child
• one or more children in the home is in the 3 to 4 year old age range
• English-speaking parent
• parent stated an interest to participate in the program
• parent completes informed consent process
• family experiencing economic disadvantage
• parenting challenges due to child behavior

Exclusion Criteria:

• an open Child Protective Services maltreatment case on the family
• parent receiving inpatient treatment or enrolled in an institutional-residential treatment program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Provide the 15-week Healthy Child Development Program intervention	Behavioral: Healthy Child Development Program; The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.
No Intervention: Wait list control; Not provide the Healthy Child Development Program during study: Individuals in this condition do not participate in the intervention program until after the study period is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Behavior Problems	Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.	baseline, pre-intervention
Child Behavior Problems	Child behavior problems refers to the Eyberg Child Behavior Inventory Intensity Scale, which is the sum of parental report responses on 36 items. The minimum and maximum values on this measure are 36 and 252 respectively, with higher scores meaning a worse outcome.	six months after baseline assessment
Child Physical Activity	Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.	baseline, pre-intervention
Child Physical Activity	Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day for each level of activity, to arrive at the average number of minutes per day the child spends engaging in moderate and vigorous physical activity.	six months after baseline assessment
Child Screen Time	Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.	baseline, pre-intervention
Child Screen Time	Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.	six months after baseline assessment
Child Sleep Duration	Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.	baseline, pre-intervention
Child Sleep Duration	Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.	six months after baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Difficulties	Parenting difficulties refers to the Parenting Scale Total Score. The total score is the average of 30 items, with a minimum value of 1.0 and a maximum value of 7.0. Higher scores mean a worse outcome (i.e., greater parenting difficulties).	baseline, pre-intervention
Parenting Difficulties	Parenting difficulties refers to the Parenting Scale Total Score. The total score is the average of 30 items, with a minimum value of 1.0 and a maximum value of 7.0. Higher scores mean a worse outcome (i.e., greater parenting difficulties).	six months after baseline assessment
Parental Stress	Parental stress refers to the Parenting Daily Hassles Scale, which is the total of 20 items. The minimum and maximum values are 0 and 80 respectively, with higher scores meaning a worse outcome (i.e., greater parental stress).	baseline, pre-intervention
Parental Stress	Parental stress refers to the Parenting Daily Hassles Scale, which is the total of 20 items. The minimum and maximum values are 0 and 80 respectively, with higher scores meaning a worse outcome (i.e., greater parental stress).	six months after baseline assessment
Parental Confidence	Parental confidence refers to the Parenting Sense of Competence scale. This scale, based on the sum of responses on 17 items, ranges from a minimum of 17 and a maximum of 102, with higher scores meaning a better outcome (i.e., greater parental confidence).	baseline, pre-intervention
Parental Confidence	Parental confidence refers to the Parenting Sense of Competence scale. This scale, based on the sum of responses on 17 items, ranges from a minimum of 17 and a maximum of 102, with higher scores meaning a better outcome (i.e., greater parental confidence).	six months after baseline assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention involvement and dropout	Intervention involvement and dropout will be examined through a follow up interview to understand components of the intervention that participants appreciated and reasons for dropping out of the intervention.	immediately after the intervention
Number of Incomplete responses	Each measure will be examined for incomplete responses. Within measures with incomplete responses, item by item incomplete totals will be examined.	baseline, pre-intervention
Number of Incomplete responses	Each measure will be examined for incomplete responses. Within measures with incomplete responses, item by item incomplete totals will be examined.	immediately after the intervention
Incomplete use of accelerometer	Accelerometer data will be examined to determine when incomplete use of the accelerometer occurred.	immediately after the intervention
Acceptability of parent logging and accelerometer procedures	Acceptability of parent logging and accelerometer procedures will be assessed through semi-structured qualitative interviews with parents.	immediately after the intervention
Level of understanding of the standardized measures	During the semi-structured qualitative interview, parents will also be asked to give feedback on their level of understanding of the standardized instruments.	immediately after the intervention

Collaborators and Investigators

• Sponsor: University of South Carolina
• Investigators: Principal Investigator: Kristen D Seay, Ph.D., MSW, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00091502

Drug and device information, study documents

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