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 Contact: Name: Kristen D Seay, Ph.D., MSW; Phone Number: 803-777-4221; Email: kdseay@mailbox.sc.edu

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
No Intervention: Wait list control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child behavior problems	The Child Behavior Inventory will be utilized to measure parent report of child behavior problems. It is a 36-item measure that records the parent's perception of intensity of the child's disruptive behaviors and whether or not the parent believes this behavior is a problem. Intensity of the child's behavior problem is continuous, ranging from 1 (i.e., child never engages in the behavior) to 7 (i.e., child always engages in the behavior). For behaviors the child engages in, parents respond whether or not this a problem for them.	baseline, pre-intervention
Child behavior problems	The Child Behavior Inventory will be utilized to measure parent report of child behavior problems. It is a 36-item measure that records the parent's perception of intensity of the child's disruptive behaviors and whether or not the parent believes this behavior is a problem. Intensity of the child's behavior problem is continuous, ranging from 1 (i.e., child never engages in the behavior) to 7 (i.e., child always engages in the behavior). For behaviors the child engages in, parents respond whether or not this a problem for them.	immediately after the intervention
Child physical activity	Child physical activity will be measured using an ActiGraph Link accelerometer to assess the number of minutes each day which the child spends in sedentary, light, 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 which the child spends in sedentary, light, moderate, and vigorous physical activity.	immediately after the intervention
Child screen time	In addition to measures of sedentary behavior pulled from the wrist-placed ActiGraph Link accelerometer, parents will be asked to log the daily amount of child screen time at home.	baseline, pre-intervention
Child screen time	In addition to measures of sedentary behavior pulled from the wrist-placed ActiGraph Link accelerometer, parents will be asked to log the daily amount of child screen time at home.	immediately after the intervention
Child sleep duration	Child sleep duration will be measured with the ActiGraph accelerometer. Data will also be verified using parent report of the time the child went to bed and the time the child woke up collected through the daily parent log.	baseline, pre-intervention
Child sleep duration	Child sleep duration will be measured with the ActiGraph accelerometer. Data will also be verified using parent report of the time the child went to bed and the time the child woke up collected through the daily parent log.	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting difficulties	Parenting difficulties will be assessed with the Parenting Scale. The 30-item Parenting Scale is a self-report instrument that assesses ineffective parenting in discipline situations.	baseline, pre-intervention
Parenting difficulties	Parenting difficulties will be assessed with the Parenting Scale. The 30-item Parenting Scale is a self-report instrument that assesses ineffective parenting in discipline situations.	immediately after the intervention
Parental stress	Parental stress will be measured with the Parenting Daily Hassles Scale (PDHS). Parenting stress is associated with parenting behaviors and child behavior problems. The PDHS is a 20-item instrument that measures the extent to which parents feel daily stress from routine events that can make life difficult for families with young children. Frequency scores range from 0-80 with higher scores indicating more frequent child behavior problems. Intensity scores range from 0-100 with higher scores indicating a higher intensity of parenting hassles.	baseline, pre-intervention
Parental stress	Parental stress will be measured with the Parenting Daily Hassles Scale (PDHS). Parenting stress is associated with parenting behaviors and child behavior problems. The PDHS is a 20-item instrument that measures the extent to which parents feel daily stress from routine events that can make life difficult for families with young children. Frequency scores range from 0-80 with higher scores indicating more frequent child behavior problems. Intensity scores range from 0-100 with higher scores indicating a higher intensity of parenting hassles.	immediately after the intervention
Parental confidence	Parental confidence will be assessed with the Parenting Sense of Competence scale, a Likert-scale in which higher scores indicate a stronger sense of self-efficacy as a parent. Total scores range from 17-102.	baseline, pre-intervention
Parental confidence	Parental confidence will be assessed with the Parenting Sense of Competence scale, a Likert-scale in which higher scores indicate a stronger sense of self-efficacy as a parent. Total scores range from 17-102.	immediately after the intervention

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): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

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