Child Behavior, Child Health, Child, Preschool, Parents
Conditions
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.
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.
Interventions
BEHAVIORALHealthy 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.
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Behavior Problems | baseline, pre-intervention | 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. |
| Child Physical Activity | baseline, pre-intervention | 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. |
| Child Screen Time | baseline, pre-intervention | Multi-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home. |
| Child Sleep Duration | baseline, pre-intervention | Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Stress | baseline, pre-intervention | 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). |
| Parental Confidence | baseline, pre-intervention | 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). |
| Parenting Difficulties | baseline, pre-intervention | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 32 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Intervention | Wait List Control | Total |
|---|---|---|---|
| Age, Continuous | 4.03 Years STANDARD_DEVIATION 0.66 | 3.98 Years STANDARD_DEVIATION 0.79 | 4.01 Years STANDARD_DEVIATION 0.72 |
| Baseline Outcome Measure Child Behavior Problems | 132.8 units on a scale STANDARD_DEVIATION 35.5 | 145.4 units on a scale STANDARD_DEVIATION 30.9 | 139.2 units on a scale STANDARD_DEVIATION 33.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 30 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 13 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 14 Participants | 29 Participants |
| Region of Enrollment United States | 31 participants | 32 participants | 63 participants |
| Sex: Female, Male Child Gender Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Child Gender Male | 21 Participants | 24 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 0 / 31 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
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.
Time frame: six months after baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Child Behavior Problems | 108.2 score on a scale | Standard Deviation 31.4 |
| Wait List Control | Child Behavior Problems | 139.1 score on a scale | Standard Deviation 30.3 |
p-value: <0.001ANCOVA
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.
Time frame: baseline, pre-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Child Behavior Problems | 132.8 score on a scale | Standard Deviation 35.5 |
| Wait List Control | Child Behavior Problems | 145.4 score on a scale | Standard Deviation 30.9 |
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.
Time frame: baseline, pre-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Child Physical Activity | 91.9 minutes | Standard Error 6.99 |
| Wait List Control | Child Physical Activity | 92.9 minutes | Standard Error 6.49 |
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.
Time frame: six months after baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Child Physical Activity | 88.6 minutes | Standard Error 7.13 |
| Wait List Control | Child Physical Activity | 82.5 minutes | Standard Error 7.4 |
p-value: =0.56Mixed Models Analysis
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.
Time frame: baseline, pre-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Child Screen Time | 1.59 hours | Standard Error 0.21 |
| Wait List Control | Child Screen Time | 2.29 hours | Standard Error 0.21 |
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.
Time frame: six months after baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Child Screen Time | 1.35 hours | Standard Error 0.21 |
| Wait List Control | Child Screen Time | 2.00 hours | Standard Error 0.21 |
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.
Time frame: six months after baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Child Sleep Duration | 10.4 hours | Standard Error 0.15 |
| Wait List Control | Child Sleep Duration | 10.1 hours | Standard Error 0.15 |
p-value: =0.99Mixed Models Analysis
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.
Time frame: baseline, pre-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Child Sleep Duration | 10.4 hours | Standard Error 0.14 |
| Wait List Control | Child Sleep Duration | 10.2 hours | Standard Error 0.14 |
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).
Time frame: baseline, pre-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Parental Confidence | 68.3 score on a scale | Standard Deviation 10.7 |
| Wait List Control | Parental Confidence | 71.6 score on a scale | Standard Deviation 9.7 |
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).
Time frame: six months after baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Parental Confidence | 74.96 score on a scale | Standard Deviation 10.48 |
| Wait List Control | Parental Confidence | 73.79 score on a scale | Standard Deviation 9.4 |
p-value: =0.062ANCOVA
p-value: =0.78Mixed Models Analysis
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).
Time frame: baseline, pre-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Parental Stress | 47.3 score on a scale | Standard Deviation 13.1 |
| Wait List Control | Parental Stress | 47.2 score on a scale | Standard Deviation 7.8 |
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).
Time frame: six months after baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Parental Stress | 40.24 score on a scale | Standard Deviation 10.5 |
| Wait List Control | Parental Stress | 45.72 score on a scale | Standard Deviation 9.07 |
p-value: <0.01ANCOVA
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).
Time frame: baseline, pre-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Parenting Difficulties | 3.29 score on a scale | Standard Deviation 0.78 |
| Wait List Control | Parenting Difficulties | 3.29 score on a scale | Standard Deviation 0.65 |
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).
Time frame: six months after baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Parenting Difficulties | 2.90 score on a scale | Standard Deviation 0.71 |
| Wait List Control | Parenting Difficulties | 3.17 score on a scale | Standard Deviation 0.63 |
p-value: <0.05ANCOVA