The Healthy Child Development Program Study

NCT04622969 | Completed Results

• 1 other identifier: Pro00091502
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Behavior; Child Health; Child, Preschool; Parents

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Parenting Difficulties

  baseline, pre-intervention

• Parenting Difficulties

  six months after baseline assessment

• Parental Stress

  baseline, pre-intervention

• Parental Stress

  six months after baseline assessment

• Parental Confidence

  baseline, pre-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Provide the 15-week Healthy Child Development Program intervention

Behavioral: Healthy Child Development Program

Wait list control

NO INTERVENTION

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.

Interventions

Healthy Child Development Program BEHAVIORAL

The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.

Intervention

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29204, United States

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Director, Office of Research Compliance
• Organization: University of South Carolina

lisaj@mailbox.sc.edu

8037777095

Study Officials

• Kristen D Seay, Ph.D., MSW

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: November 10, 2020
• Study Start: April 12, 2021
• Primary Completion: January 10, 2024
• Study Completion: January 26, 2024
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-04

Locations

US (1)