Child BehaviorNCT06111651
Family-Based Prevention With Black and Latinx Children
A study testing Parenting Intervention in people with Child Behavior and Health Behavior, run by University of South Carolina at 1 site in United States.
Trial summary
The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Health Behavior
- What is being tested?
- Parenting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Eligible children will:
- be between the ages of 3-6 years
- identify as Black/African American or Latinx/Hispanic
- have a parent or caregiver willing to participate in the intervention that: (a) lives in the same household as the child ≥50% of the time, (b) has primary responsibility for the child, and (c) speaks English or Spanish.
Who cannot join
- Consistent with typical methods associated with a universal prevention approach, there are minimal exclusion criteria. Children will be excluded who:
- have a cognitive/psychological condition that limits the child's ability to communicate
- have a physical health condition that limits the child's ability to be physically active
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Family-Based Prevention to Promote the Social-Emotional Functioning and Healthy Lifestyle Behaviors of Black & Latinx Children
The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children.
Read the detailed description
This pilot project is novel in that it (a) interweaves positive parenting practices, ethnic-racial socialization, and healthy lifestyle behaviors into a prevention program for Black and Latinx families, and (b) targets preschool-aged children using a brief, universal prevention approach, which increases potential for dissemination and scalability. The guiding hypothesis is that incorporating these components into a parenting intervention will lead to improvements in children's health as compared to a control condition. A type 1 hybrid effectiveness-implementation design is used to simultaneously test intervention effectiveness while also gathering information on intervention delivery to inform future implementation trials. The specific aims are to: (a) test the preliminary effects of a preventive intervention on the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children, (b) identify the preliminary effects of the intervention on parenting outcomes, and (c) examine potential barriers and facilitators to intervention delivery.
- Conditions
- Child Behavior, Health Behavior
- Being tested
- Parenting Intervention
- Keywords
- parent training, randomized controlled trial, pilot study, child development, implementation trial, prevention
- Medical subject headings
- Child Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting InterventionBehavioural
parent training program with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | parents will participate in a multicomponent parenting intervention Receives: Behavioral: Parenting Intervention |
| Control | No intervention | parents will receive information about healthy eating habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
child social-emotional functioning
Parent-reported assessment of various positive and negative child behaviors. Likert scale values range from 0 to 2, with higher values typically indicating greater dysfunctional behavior.
Measured: pre (weeks 0-2) and post intervention (weeks 6-8)
child physical activity
Time spent sedentary and in light, moderate, and vigorous physical activity each day will be collected using a waterproof accelerometer. Validated methods will be used to identify valid days and derive activity intensities.
Measured: pre (weeks 0-2) and post intervention (weeks 6-8)
child sleep
Child average nightly sleep duration and quality will be calculated from data obtained using a waterproof accelerometer.
Measured: pre (weeks 0-2) and post intervention (weeks 6-8)
Secondary outcomes (2)
parenting practices
Parent-reported measure of different dimensions of parenting (e.g., harsh parenting, permissive parenting). Likert scale values range from 1 to 7, with higher values indicating greater dysfunctional parenting.
Measured: pre (weeks 0-2) and post intervention (weeks 6-8)
ethnic-racial socialization practices
Parent-reported measure of attitudes about and use of various ethnic-racial socialization practices. Likert scale values range from 1 to 5, with higher values indicating more positive ethnic-racial socialization attitudes and practices.
Measured: pre (weeks 0-2) and post intervention (weeks 6-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start5 Jun 2024
- Primary completion30 Nov 2025
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Daniel Cooper, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111651
- Sponsor's protocol ID
- Pro00124236
- Other IDs
- 5P20GM130420
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Prevention to Promote the Social-Emotional Functioning and Healthy Lifestyle Behaviors of Black & Latinx Children
- ClinicalTrials.gov ID
- NCT06111651
- Acronym / sponsor ID
- Pro00124236
- Conditions
- Child Behavior, Health Behavior
- Keywords
- parent training, randomized controlled trial, pilot study, child development, implementation trial, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children.
Detailed description
This pilot project is novel in that it (a) interweaves positive parenting practices, ethnic-racial socialization, and healthy lifestyle behaviors into a prevention program for Black and Latinx families, and (b) targets preschool-aged children using a brief, universal prevention approach, which increases potential for dissemination and scalability. The guiding hypothesis is that incorporating these components into a parenting intervention will lead to improvements in children's health as compared to a control condition. A type 1 hybrid effectiveness-implementation design is used to simultaneously test intervention effectiveness while also gathering information on intervention delivery to inform future implementation trials. The specific aims are to: (a) test the preliminary effects of a preventive intervention on the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children, (b) identify the preliminary effects of the intervention on parenting outcomes, and (c) examine potential barriers and facilitators to intervention delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Parenting Interventionparents will participate in a multicomponent parenting intervention |
| Control | No intervention | –parents will receive information about healthy eating habits |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- be between the ages of 3-6 years
- identify as Black/African American or Latinx/Hispanic
- have a parent or caregiver willing to participate in the intervention that: (a) lives in the same household as the child ≥50% of the time, (b) has primary responsibility for the child, and (c) speaks English or Spanish.
Key exclusion criteria (3 listed)
- Consistent with typical methods associated with a universal prevention approach, there are minimal exclusion criteria. Children will be excluded who:
- have a cognitive/psychological condition that limits the child's ability to communicate
- have a physical health condition that limits the child's ability to be physically active
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 |
|---|---|---|
| Parenting Interventionparent training program with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors | Behavioural | Intervention |
Primary outcome
child social-emotional functioning
Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)
Parent-reported assessment of various positive and negative child behaviors. Likert scale values range from 0 to 2, with higher values typically indicating greater dysfunctional behavior.
child physical activity
Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)
Time spent sedentary and in light, moderate, and vigorous physical activity each day will be collected using a waterproof accelerometer. Validated methods will be used to identify valid days and derive activity intensities.
child sleep
Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)
Child average nightly sleep duration and quality will be calculated from data obtained using a waterproof accelerometer.
2 secondary outcomes
parenting practices
Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)
ethnic-racial socialization practices
Time frame: pre (weeks 0-2) and post intervention (weeks 6-8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Intervention in people with Child Behavior and Health Behavior, 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 4 inclusion and 3 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 22 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 social-emotional functioning (time frame: pre (weeks 0-2) and post intervention (weeks 6-8)). The study lists 3 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 22 Jan 2026.