Brief Interventions to Improve Behavior Outcomes and Prevent Cavities
1 other identifier
interventional
750
1 country
1
Brief Summary
The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
April 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2035
March 31, 2026
November 1, 2025
1.7 years
August 7, 2024
March 25, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
3 years, or until the end of the study.
Secondary Outcomes (3)
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 Arms (3)
Child behavior management - free resources
EXPERIMENTALTwo minutes of education about child behavior management coupled with free resources.
Child behavior management - handbook
EXPERIMENTALTwo minutes of education about child behavior management coupled with free resources and a handbook
Cavity Prevention
EXPERIMENTALTwo minutes of education about how to prevent cavities coupled with a 2 page handout.
Interventions
Multimedia tool and handbook designed to educate parents about healthy discipline strategies.
Two page handout with information about how to prevent cavities.
Eligibility Criteria
You may qualify if:
- Parents of 9 month to 3 year old children.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt Children's Primary Care One Hundred Oaks
Nashville, Tennessee, 37204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seth J Scholer, MD, MPH
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
August 7, 2024
First Posted
September 19, 2024
Study Start
April 7, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2035
Last Updated
March 31, 2026
Record last verified: 2025-11