Child BehaviorNCT04622969
The Healthy Child Development Program Study
A study testing Healthy Child Development Program in people with Child Behavior and Child Health, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Child Health, Child, Preschool
- What is being tested?
- Healthy Child Development Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 26 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- an open Child Protective Services maltreatment case on the family
- parent receiving inpatient treatment or enrolled in an institutional-residential treatment program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29204
About this study
Official title: Targeting Behavioral Adjustment and Healthy Lifestyle in Preschool-age Children Using an Integrated Family-Based Intervention
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.
Read the 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.
- Conditions
- Child Behavior, Child Health, Child, Preschool, Parents
- Being tested
- Healthy Child Development Program
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Child Development ProgramBehavioural
The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Provide the 15-week Healthy Child Development Program intervention Receives: Behavioral: Healthy Child Development Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, pre-intervention
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.
Measured: 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.
Measured: 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.
Measured: six months after baseline assessment
Secondary outcomes (6)
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).
Measured: baseline, pre-intervention
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: six months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start12 Apr 2021
- Primary completion10 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Prinz, PhD, University of South Carolina
- Investigators
- Kristen D Seay, Ph.D., MSW, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622969
- Sponsor's protocol ID
- Pro00091502
- Status last verified
- Apr 2025
- First submitted
- 24 Oct 2020
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Behavioral Adjustment and Healthy Lifestyle in Preschool-age Children Using an Integrated Family-Based Intervention
- ClinicalTrials.gov ID
- NCT04622969
- Acronym / sponsor ID
- Pro00091502
- Conditions
- Child Behavior, Child Health, Child, Preschool, Parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Healthy Child Development ProgramProvide 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- an open Child Protective Services maltreatment case on the family
- parent receiving inpatient treatment or enrolled in an institutional-residential treatment program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Child Development ProgramThe Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices. | Behavioural | Intervention |
Primary outcome
Child Behavior Problems
Time frame: 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 Behavior Problems
Time frame: six months after baseline assessment
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
Time frame: 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 Physical Activity
Time frame: six months after baseline assessment
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
Time frame: 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 Screen Time
Time frame: six months after baseline assessment
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
Time frame: 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.
Child Sleep Duration
Time frame: six months after baseline assessment
Multi-day estimate of child sleep duration will be derived from parental log for the daily amount of child sleep duration at home.
6 secondary outcomes
Parenting Difficulties
Time frame: baseline, pre-intervention
Parenting Difficulties
Time frame: six months after baseline assessment
Parental Stress
Time frame: baseline, pre-intervention
Parental Stress
Time frame: six months after baseline assessment
Parental Confidence
Time frame: baseline, pre-intervention
Parental Confidence
Time frame: six months after baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen D Seay, Ph.D., MSW principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Child Development Program in people with Child Behavior and Child Health, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Behavior Problems (time frame: baseline, pre-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.