Clinical trial NCT06138405: Dental-Child Interaction Training
Official title: Implementing Evidence-based Behavioral Skills in Pediatric Oral Healthcare Providers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Child Behavior
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2023-11-18
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To assess dental providers' usage of DCIT behavioral methods in the training workshop.
timeFrame: Immediately pre- and post-workshop
Secondary outcomes:
measure: To assess dental providers' knowledge of DCIT principles and methods.
timeFrame: Immediately pre- and post-workshop
Other outcomes:
measure: To assess the acceptability of dental providers' usage of DCIT behavioral methods in their dental practices/clinics.
timeFrame: Immediately post- workshop and again two and 6 months post workshop
measure: To assess dental providers' ability to use DCIT behavioral methods in their clinic or practice setting.
timeFrame: 2 months pre-workshop to 2 months post-workshop
measure: To assess child behavior when dental providers use DCIT behavioral methods in their clinic or practice setting.
timeFrame: 2 months pre-workshop to 2 months post-workshop
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Florida
name: Daniel W McNeil, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Cheryl B McNeil, PhD
role: PRINCIPAL_INVESTIGATOR
References: