The Healthy Child Development Program Study

Child Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622969
• Other study ID #: Pro00091502
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: January 26, 2024

Study information

• Verified date: January 2024
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 26, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior
• Child Health
• Child, Preschool
• Parents

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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Incomplete use of accelerometer	Accelerometer data will be examined to determine when incomplete use of the accelerometer occurred.	immediately after the intervention
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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