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Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06588725
Enrollment
750
Registered
2024-09-19
Start date
2025-04-07
Completion date
2035-01-01
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cavity, Dental, Child Behavior, Parenting

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.

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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Months to 3 Years
Healthy volunteers
Yes

Inclusion criteria

* Parents of 9 month to 3 year old children.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Child behavior problems3 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 outcomes3 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

MeasureTime frameDescription
Planned change to care for behavioral healthSame 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 cavitiesSame 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 interventions2-4 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSeth J Scholer, MD, MPH

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026