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Enrolling by Invitation

NCT Number: NCT06588725

Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

The investigators will study brief educational interventions designed to address childhood behavior problems and prevent cavities.

Enrolling by Invitation

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Key information

Conditions

Parenting Behavior Cavity, Dental Child Behavior Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

9 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Children's Primary Care One Hundred Oaks

Nashville, Tennessee, 37204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parents of 9 month to 3 year old children.

Exclusion criteria

-

Treatment and study plan

Play Nicely

Behavioral

Multimedia tool and handbook designed to educate parents about healthy discipline strategies.

Cavity Prevention Handout

Behavioral

Two page handout with information about how to prevent cavities.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2035
First posted
Sep 19, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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