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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Provide the 15-week Healthy Child Development Program intervention |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen D Seay, Ph.D., MSW | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Provide the 15-week Healthy Child Development Program intervention 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Provide the 15-week Healthy Child Development Program intervention 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, pre-intervention |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Provide the 15-week Healthy Child Development Program intervention 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Office of Research Compliance | University of South Carolina | 8037777095 | lisaj@mailbox.sc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2025 | Apr 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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 |
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 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Outcome Measure Child Behavior Problems | Mean | Standard Deviation | units on a scale |
|
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.
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | six months after baseline assessment |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | minutes | 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 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. | Posted | Mean | Standard Error | minutes | six months after baseline assessment |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | hours | baseline, pre-intervention |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | hours | six months after baseline assessment |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | hours | baseline, pre-intervention |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | hours | six months after baseline assessment |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | baseline, pre-intervention |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | six months after baseline assessment |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | baseline, pre-intervention |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | six months after baseline assessment |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | baseline, pre-intervention |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | six months after baseline assessment |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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| Mean Difference (Net) |
| 0.047 |
| Standard Error of the Mean |
| 0.170 |
| 2-Sided |
| Superiority |