ParentingNCT06588725
Brief Interventions to Improve Behavior Outcomes and Prevent Cavities
A study testing Play Nicely and Cavity Prevention Handout in people with Parenting and Cavity, Dental, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities. Read more about this study
- Who is it for?
- Ages 9 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting, Cavity, Dental, Child Behavior
- What is being tested?
- Play Nicely and Cavity Prevention Handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents of 9 month to 3 year old children.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt Children's Primary Care One Hundred Oaks
Nashville, Tennessee, 37204
About this study
The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities.
Read the detailed description
The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities. Participants will be parents of children, ages 9 months to 3 years, presenting with their child for a well child visit. Parent/child dyads will be randomized into three different groups: Group 1 will be introduced to an online educational intervention to address childhood behavior problem, Group 2 will be introduced to a printed educational intervention to address childhood behavior problems, and Group 3 will be introduced to an educational intervention to prevent cavities. Study procedures will include 1) the educational intervention in the examination room before the clinic visit, 2) a brief survey immediately after the clinic visit and 3) a brief survey in 2-4 months sent via REDCap, and 4) follow up health and insurance records related to the study interventions.
- Conditions
- Parenting, Cavity, Dental, Child Behavior
- Being tested
- Play Nicely, Cavity Prevention Handout
- Medical subject headings
- Dental Caries, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play NicelyBehavioural
Multimedia tool and handbook designed to educate parents about healthy discipline strategies.
Cavity Prevention HandoutBehavioural
Two page handout with information about how to prevent cavities.
| Study group | Role | What they receive |
|---|---|---|
| Child behavior management - free resources | Experimental | Two minutes of education about child behavior management coupled with free resources. Receives: Behavioral: Play Nicely |
| Child behavior management - handbook | Experimental | Two minutes of education about child behavior management coupled with free resources and a handbook Receives: Behavioral: Play Nicely |
| Cavity Prevention | Experimental | Two minutes of education about how to prevent cavities coupled with a 2 page handout. Receives: Behavioral: Cavity Prevention Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child behavior problems
We will review the medical chart for the following outcomes: Number of participants with child behavior problems; referral to mental/behavioral health provider; use of psychotropic medications.
Measured: 3 years, or until the end of the study.
Cavity-related outcomes
We will review the medical chart and dental records for cavity related outcomes including number of children with cavities, fillings, and crowns.
Measured: 3 years, or until the end of the study.
Secondary outcomes (3)
Planned change to care for behavioral health
The survey will ask parents about planned change to care for child's behavioral health and ask about whether the parent feels that they have the resources to address behavioral needs.
Measured: Same day as enrollment, for 3 years or until the end of the study.
Planned change to prevent cavities
The survey will ask parents about planned change to prevent cavities and ask about whether the parent feels that they have the resources to prevent cavities.
Measured: Same day as enrollment, for 3 years or until the end of the study.
Report on helpfulness of interventions
The survey will ask parents whether the information they received at the well visit was helpful and what, if anything, they are doing differently to address behavioral health or to prevent cavities.
Measured: 2-4 months after enrollment, for 3 years or until the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Scholer, Vanderbilt University Medical Center
- Investigators
- Seth J Scholer, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588725
- Sponsor's protocol ID
- 241240
- Status last verified
- Nov 2025
- First submitted
- 7 Aug 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Interventions to Improve Behavior Outcomes and Prevent Cavities
- ClinicalTrials.gov ID
- NCT06588725
- Acronym / sponsor ID
- 241240
- Conditions
- Parenting, Cavity, Dental, Child Behavior
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 19 Sep 2024 (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 investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities.
Detailed description
The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities. Participants will be parents of children, ages 9 months to 3 years, presenting with their child for a well child visit. Parent/child dyads will be randomized into three different groups: Group 1 will be introduced to an online educational intervention to address childhood behavior problem, Group 2 will be introduced to a printed educational intervention to address childhood behavior problems, and Group 3 will be introduced to an educational intervention to prevent cavities. Study procedures will include 1) the educational intervention in the examination room before the clinic visit, 2) a brief survey immediately after the clinic visit and 3) a brief survey in 2-4 months sent via REDCap, and 4) follow up health and insurance records related to the study interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child behavior management - free resources | Experimental | Behavioral: Play NicelyTwo minutes of education about child behavior management coupled with free resources. |
| Child behavior management - handbook | Experimental | Behavioral: Play NicelyTwo minutes of education about child behavior management coupled with free resources and a handbook |
| Cavity Prevention | Experimental | Behavioral: Cavity Prevention HandoutTwo minutes of education about how to prevent cavities coupled with a 2 page handout. |
Who may qualify
- Ages
- 9 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents of 9 month to 3 year old children.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Play NicelyMultimedia tool and handbook designed to educate parents about healthy discipline strategies. | Behavioural | Child behavior management - free resources, Child behavior management - handbook |
| Cavity Prevention HandoutTwo page handout with information about how to prevent cavities. | Behavioural | Cavity Prevention |
Primary outcome
Child behavior problems
Time frame: 3 years, or until the end of the study.
We will review the medical chart for the following outcomes: Number of participants with child behavior problems; referral to mental/behavioral health provider; use of psychotropic medications.
Cavity-related outcomes
Time frame: 3 years, or until the end of the study.
We will review the medical chart and dental records for cavity related outcomes including number of children with cavities, fillings, and crowns.
3 secondary outcomes
Planned change to care for behavioral health
Time frame: Same day as enrollment, for 3 years or until the end of the study.
Planned change to prevent cavities
Time frame: Same day as enrollment, for 3 years or until the end of the study.
Report on helpfulness of interventions
Time frame: 2-4 months after enrollment, for 3 years or until the end of the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
Seth J Scholer, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play Nicely and Cavity Prevention Handout in people with Parenting and Cavity, Dental, run by Vanderbilt University Medical Center 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 31 Mar 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?
This study is still under way. Results are not available in the source record yet.
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: 3 years, or until the end of the study.). The study lists 2 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 31 Mar 2026.