Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

March 25, 2026 updated by: Seth Scholer, Vanderbilt University Medical Center
The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parents of 9 month to 3 year old children.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Child behavior management - free resources
Two minutes of education about child behavior management coupled with free resources.
Behavioral: Play Nicely
Multimedia tool and handbook designed to educate parents about healthy discipline strategies.
Experimental: Child behavior management - handbook
Two minutes of education about child behavior management coupled with free resources and a handbook
Behavioral: Play Nicely
Multimedia tool and handbook designed to educate parents about healthy discipline strategies.
Experimental: Cavity Prevention
Two minutes of education about how to prevent cavities coupled with a 2 page handout.
Behavioral: Cavity Prevention Handout
Two page handout with information about how to prevent cavities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years, or until the end of the study.
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 years, or until the end of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Planned change to care for behavioral health
Time Frame: Same day as enrollment, for 3 years or until the end of the study.
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.
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.
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.
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.
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.
2-4 months after enrollment, for 3 years or until the end of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Seth J Scholer, MD, MPH, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

September 7, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 241240

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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