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临床试验/NCT06588725
NCT06588725Enrolling By Invitation不适用

Brief Interventions to Improve Behavior Outcomes and Prevent Cavities

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2025年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
750
试验地点
2
主要终点
Child behavior problems

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parents of 9 month to 3 year old children.

排除标准

  • 未提供

研究组 & 干预措施

Cavity Prevention

Experimental

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

干预措施: Cavity Prevention Handout (Behavioral)

Child behavior management - free resources

Experimental

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

干预措施: Play Nicely (Behavioral)

Child behavior management - handbook

Experimental

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

干预措施: Play Nicely (Behavioral)

结局指标

主要结局

Child behavior problems

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seth Scholer

Professor of Pediatrics

Vanderbilt University Medical Center

研究点 (2)

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