Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

NCT ID: NCT06588725

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2035-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Parenting Cavity, Dental Child Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Child behavior management - free resources

Two minutes of education about child behavior management coupled with free resources.

Group Type EXPERIMENTAL

Play Nicely

Intervention Type BEHAVIORAL

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

Child behavior management - handbook

Two minutes of education about child behavior management coupled with free resources and a handbook

Group Type EXPERIMENTAL

Play Nicely

Intervention Type BEHAVIORAL

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

Cavity Prevention

Two minutes of education about how to prevent cavities coupled with a 2 page handout.

Group Type EXPERIMENTAL

Cavity Prevention Handout

Intervention Type BEHAVIORAL

Two page handout with information about how to prevent cavities.

Interventions

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Play Nicely

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

Intervention Type BEHAVIORAL

Cavity Prevention Handout

Two page handout with information about how to prevent cavities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parents of 9 month to 3 year old children.

Exclusion Criteria

\-
Minimum Eligible Age

9 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seth Scholer

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seth J Scholer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt Children's Primary Care One Hundred Oaks

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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241240

Identifier Type: -

Identifier Source: org_study_id

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