Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

Not Applicable

Not yet recruiting

• Conditions: Parenting; Cavity, Dental; Child Behavior
• Interventions: Behavioral: Play Nicely; Behavioral: Cavity Prevention Handout

• Registration Number: NCT06588725
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-09-07
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-01
• Study Start: 2025-04-15
• Primary Completion: 2027-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Parents of 9 month to 3 year old children.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Child behavior management - free resources	Play Nicely	Two minutes of education about child behavior management coupled with free resources.
Child behavior management - handbook	Play Nicely	Two minutes of education about child behavior management coupled with free resources and a handbook
Cavity Prevention	Cavity Prevention Handout	Two minutes of education about how to prevent cavities coupled with a 2 page handout.

Primary Outcome Measures

Name	Time	Method
Child behavior problems	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	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 Outcome Measures

Name	Time	Method
Planned change to care for behavioral health	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.
Planned change to prevent cavities	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.
Report on helpfulness of interventions	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.