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Clinical Trials/NCT06588725
NCT06588725
Enrolling by Invitation
N/A

Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

Vanderbilt University Medical Center1 site in 1 country750 target enrollmentApril 7, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parenting
Sponsor
Vanderbilt University Medical Center
Enrollment
750
Locations
1
Primary Endpoint
Child behavior problems
Status
Enrolling by Invitation
Last Updated
11 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 7, 2025
End Date
January 2035
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seth Scholer

Professor of Pediatrics

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Parents of 9 month to 3 year old children.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Planned change to care for behavioral health(Same day as enrollment, for 3 years or until the end of the study.)
  • Planned change to prevent cavities(Same day as enrollment, for 3 years or until the end of the study.)
  • Report on helpfulness of interventions(2-4 months after enrollment, for 3 years or until the end of the study.)

Study Sites (1)

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