Trial Outcomes & Findings for The Healthy Child Development Program Study (NCT NCT04622969)
NCT ID: NCT04622969
Last Updated: 2025-05-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
baseline, pre-intervention
Results posted on
2025-05-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
The Healthy Child Development Program Study
Baseline characteristics by cohort
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.03 Years
STANDARD_DEVIATION 0.66 • n=5 Participants
|
3.98 Years
STANDARD_DEVIATION 0.79 • n=7 Participants
|
4.01 Years
STANDARD_DEVIATION 0.72 • n=5 Participants
|
|
Sex: Female, Male
Child Gender · Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Child Gender · Male
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Baseline Outcome Measure Child Behavior Problems
|
132.8 units on a scale
STANDARD_DEVIATION 35.5 • n=5 Participants
|
145.4 units on a scale
STANDARD_DEVIATION 30.9 • n=7 Participants
|
139.2 units on a scale
STANDARD_DEVIATION 33.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, pre-interventionChild 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.
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Child Behavior Problems
|
132.8 score on a scale
Standard Deviation 35.5
|
145.4 score on a scale
Standard Deviation 30.9
|
PRIMARY outcome
Timeframe: six months after baseline assessmentChild 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.
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Child Behavior Problems
|
108.2 score on a scale
Standard Deviation 31.4
|
139.1 score on a scale
Standard Deviation 30.3
|
PRIMARY outcome
Timeframe: baseline, pre-interventionChild 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.
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Child Physical Activity
|
91.9 minutes
Standard Error 6.99
|
92.9 minutes
Standard Error 6.49
|
PRIMARY outcome
Timeframe: six months after baseline assessmentChild 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.
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Child Physical Activity
|
88.6 minutes
Standard Error 7.13
|
82.5 minutes
Standard Error 7.40
|
PRIMARY outcome
Timeframe: baseline, pre-interventionMulti-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Child Screen Time
|
1.59 hours
Standard Error 0.21
|
2.29 hours
Standard Error 0.21
|
PRIMARY outcome
Timeframe: six months after baseline assessmentMulti-day estimate of child screen time will be derived from parental log for the daily amount of child screen time at home.
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Child Screen Time
|
1.35 hours
Standard Error 0.21
|
2.00 hours
Standard Error 0.21
|
PRIMARY outcome
Timeframe: baseline, pre-interventionMulti-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Child Sleep Duration
|
10.4 hours
Standard Error 0.14
|
10.2 hours
Standard Error 0.14
|
PRIMARY outcome
Timeframe: six months after baseline assessmentMulti-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Child Sleep Duration
|
10.4 hours
Standard Error 0.15
|
10.1 hours
Standard Error 0.15
|
SECONDARY outcome
Timeframe: baseline, pre-interventionParenting 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).
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Parenting Difficulties
|
3.29 score on a scale
Standard Deviation 0.78
|
3.29 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: six months after baseline assessmentParenting 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).
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Parenting Difficulties
|
2.90 score on a scale
Standard Deviation 0.71
|
3.17 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: baseline, pre-interventionParental 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).
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Parental Stress
|
47.3 score on a scale
Standard Deviation 13.1
|
47.2 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: six months after baseline assessmentParental 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).
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Parental Stress
|
40.24 score on a scale
Standard Deviation 10.5
|
45.72 score on a scale
Standard Deviation 9.07
|
SECONDARY outcome
Timeframe: baseline, pre-interventionParental 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).
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Parental Confidence
|
68.3 score on a scale
Standard Deviation 10.7
|
71.6 score on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: six months after baseline assessmentParental 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).
Outcome measures
| Measure |
Intervention
n=31 Participants
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.
|
Wait List Control
n=32 Participants
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.
|
|---|---|---|
|
Parental Confidence
|
74.96 score on a scale
Standard Deviation 10.48
|
73.79 score on a scale
Standard Deviation 9.40
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Office of Research Compliance
University of South Carolina
Phone: 8037777095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place