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临床试验/NCT06138405
NCT06138405招募中不适用

Implementing Evidence-based Behavioral Skills in Pediatric Oral Healthcare Providers

University of Florida4 个研究点 分布在 1 个国家目标入组 5,808 人开始时间: 2026年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
5,808
试验地点
4
主要终点
To assess dental providers' usage of DCIT behavioral methods in the training workshop.

研究概览

简要总结

The goal of this behavioral, interventional clinical trial is to provide a specialized workshop training for dental providers (e.g., dentists, hygienists, assistants) to improve interactions with young children (2-10 years old) and parents/caregivers. The training is derived from a well-established behavior management program for preschoolers, Parent-Child Interaction Therapy (PCIT).

The main questions it aims to answer are:

  • Change in behavior of dental providers
  • Acceptability of training by dental providers

All participants will receive the same behavior training; however, one group will receive the training on a delayed schedule. Researchers will compare the immediate intervention and control group to see if the training was effective in the dental providers usage of skills.

详细描述

This is a cluster randomized clinical trial, with a two-group, parallel, delayed treatment design.

After being informed abut the study and potential risks, all dental provider participants giving written informed consent will be randomized by dental clinic/office to one of the two groups, the training (immediate intervention) group or the delayed (control) training group. Both groups will be filmed using very small and unobtrusive digital video recorders in their dental office/practice/clinic prior to the training workshop to assess for behavioral skills used with their child patients, child adherence, child fear/anxiety, and child on-task behavior.

During the training workshop, dental provider participants will complete a set of measures at the start of the workshop on their knowledge of the specific behavioral skills being presented in the training and factors contributing to their ability and willingness to implement evidence- based training components (i.e., adoption, appropriateness, feasibility, penetration, sustainability). In addition, they will be asked to demonstrate and practice their behavioral interaction skills with trained simulated child patients in a dental simulation. The workshop will take place over the course of an 8-hour training day. At the end of the day, dental providers will complete the knowledge quiz, simulation procedure, and a measure of acceptability of the training and learned skills.

Both the training and the delayed training control groups will be video recorded in their clinics at a 2-month post workshop to determine skill level. At the same time, the assessment measure for the implementation of the evidence-based training components will be completed.

During the video-recorded clinic sessions, consenting families will participate in their child's dental appointment and be asked to complete reports of child behavior, child anxiety/fear, and acceptability of the research procedures/dental practice via validated instruments. As in the R21 project, both preventive and operative appointments will be included, for generalization. After visit completion, dental staff will complete a rating of child anxiety/fear, child behavior, and a self-report of acceptability of the research procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dental Providers
  • Licensed dentist, licensed or certified dental hygienist, or dental assistant
  • Provides (or willing to consider providing) dental treatment for children between 2 years and 10 years old ->= 18 years old
  • Fluent in spoken and written English
  • Willing to be videotaped
  • Parent/Caregivers
  • Understands spoken and written English
  • Willing to be videotaped
  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Child Dental Patients
  • Child between 2 years, 0 months, and 0 days, and 10 years, 11 months, 30 days old
  • Receiving preventive, restorative, emergency or any other dental treatment
  • Accompanied by a parent/caregiver
  • Understands spoken and written English
  • Willing to be videotaped
  • Parent/guardian provides signed and dated informed consent form
  • Provide assent (if 7+ years old and who do not have an obvious cognitive impairment or are "mentally immature")
  • Willing to comply with all study procedures and be available for the duration of the study
  • In good general health as evidenced by medical history

排除标准

  • Cognitive impairment or developmental delay
  • Major medical problem in child
  • Autism or other developmental/neurodevelopmental disorders
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

研究组 & 干预措施

Delayed Intervention Group

Active Comparator

The delayed intervention group will receive the same experiential, interactive, skills-oriented workshop, but two months after the immediate intervention group.

干预措施: Delayed intervention (control) Group (Behavioral)

Immediate Intervention Group

Experimental

Experiential, interactive, skills-oriented workshop for oral healthcare providers (i.e., dentists, hygienists, and assistants) involving simulated patients and immediate pre- and post-workshop testing. The workshop involves didactics on developmentally-appropriate child behavior in the dental setting, and "over-practice" of skills, to the point of habit, by providers.

干预措施: Immediate intervention Group (Behavioral)

结局指标

主要结局

To assess dental providers' usage of DCIT behavioral methods in the training workshop.

时间窗: Immediately pre- and post-workshop

Frequency counts of Dental-Child Interaction Training (DCIT) positive (i.e., increases/change in labeled praises, behavior descriptions, direct commands) and negative (i.e., decreases/change in negative talk and no-opportunity-to-comply commands) behavioral methods and ratio of those behaviors to all coded provider behaviors involved in the interaction of the child to evaluate whether participants show demonstrated skill change as a result of the workshop. Outcome measured by observation of video-taped interactions between dental provider and (simulated) children using Dental-Dyadic Parent-Child Interaction Coding System (D-DPICS).

次要结局

  • To assess dental providers' knowledge of DCIT principles and methods.(Immediately pre- and post-workshop)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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