Dental-Child Interaction Training

NCT ID: NCT06138405

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2029-08-31

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.

Conditions

Behavior and Behavior Mechanisms; Child Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Immediate Intervention Group

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.

Group Type: EXPERIMENTAL

Immediate intervention Group

Intervention Type: BEHAVIORAL

The immediate intervention group will be video recorded in office and participate in the training workshop and assessment methods two months after.

Delayed Intervention Group

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

Group Type: ACTIVE_COMPARATOR

Delayed intervention (control) Group

Intervention Type: BEHAVIORAL

The delayed training group will also be video recorded in office but will wait an additional two months and then participate in the training and assessment methods as with the original training group.

Interventions

Immediate intervention Group

The immediate intervention group will be video recorded in office and participate in the training workshop and assessment methods two months after.

Intervention Type: BEHAVIORAL

Delayed intervention (control) Group

The delayed training group will also be video recorded in office but will wait an additional two months and then participate in the training and assessment methods as with the original training group.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel W McNeil, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Cheryl B McNeil, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Arkansas

Fayetteville, Arkansas, United States

University of Florida

Gainesville, Florida, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Central Contacts

Mary L Davis, CRDH

Role: CONTACT

MDavis@dental.ufl.edu

352-222-7034

Facility Contacts

Lauren Quetsch

Role: primary

Daniel McNeil, PhD

Role: primary

Kimon Divaris

Role: primary

Christa Lilly

Role: primary

Other Identifiers

1UG3DE032004-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202202624 - N

Identifier Type: -

Identifier Source: org_study_id