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Enrolling by invitationNCT06588725Updated Mar 31, 2026

Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

An interventional study of Play Nicely and Cavity Prevention Handout in Parenting, Cavity, Dental and Child Behavior, sponsored by Vanderbilt University Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 9 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
9 Months to 3 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Parenting
  • Cavity, Dental
  • Child Behavior
03

In context

Dental Caries

1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.

This study's planned enrollment of 750 is above the median of 60 across 967 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Months to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Parents of 9 month to 3 year old children.

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    Child behavior management - free resources

    Two minutes of education about child behavior management coupled with free resources.

    Behavioral: Play Nicely

  • Experimental
    Child behavior management - handbook

    Two minutes of education about child behavior management coupled with free resources and a handbook

    Behavioral: Play Nicely

  • Experimental
    Cavity Prevention

    Two minutes of education about how to prevent cavities coupled with a 2 page handout.

    Behavioral: Cavity Prevention Handout

Interventions

  • BehavioralPlay Nicely

    Multimedia tool and handbook designed to educate parents about healthy discipline strategies.

  • BehavioralCavity Prevention Handout

    Two page handout with information about how to prevent cavities.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years, or until the end of the study.

  2. 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.

    Time frame: 3 years, or until the end of the study.

Secondary outcomes

  1. 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.

    Time frame: Same day as enrollment, for 3 years or until the end of the study.

  2. 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.

    Time frame: Same day as enrollment, for 3 years or until the end of the study.

  3. 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.

    Time frame: 2-4 months after enrollment, for 3 years or until the end of the study.

07

Study locations

1 site
  • Vanderbilt Children's Primary Care One Hundred Oaks
    Nashville, Tennessee 37204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06588725
Responsible party
Seth Scholer (Professor of Pediatrics, Vanderbilt University Medical Center) — Principal investigator
First posted
Sep 19, 2024
Start date
Apr 7, 2025
Primary completion
Jan 2027 (estimated)
Completion
Jan 2035 (estimated)
Last update
Mar 31, 2026

Study contacts

Seth J Scholer, MD, MPH
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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