The Healthy Child Development Program Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Child Behavior, Child Health, Child, Preschool, Parents

Intervention / Treatment
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* Behavioral: Healthy Child Development Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Provide the 15-week Healthy Child Development Program intervention | Behavioral: Healthy Child Development Program<br>* The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.<br>|
| No Intervention: Wait list control<br> | |

What is the study measuring?
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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 |