NCT06138405

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Aug 2029

First Submitted

Initial submission to the registry

July 25, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

March 16, 2026

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

July 25, 2023

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Immediately pre- and post-workshop

Secondary Outcomes (1)

  • To assess dental providers' knowledge of DCIT principles and methods.

    Immediately pre- and post-workshop

Other Outcomes (3)

  • To assess the acceptability of dental providers' usage of DCIT behavioral methods in their dental practices/clinics.

    Immediately post- workshop and again two and 6 months post workshop

  • To assess dental providers' ability to use DCIT behavioral methods in their clinic or practice setting.

    2 months pre-workshop to 2 months post-workshop

  • To assess child behavior when dental providers use DCIT behavioral methods in their clinic or practice setting.

    2 months pre-workshop to 2 months post-workshop

Study Arms (2)

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.

Behavioral: Immediate intervention Group

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.

Behavioral: Delayed intervention (control) Group

Interventions

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.

Delayed Intervention Group

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

Immediate Intervention Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Arkansas

Fayetteville, Arkansas, 72701, United States

RECRUITING

University of Florida

Gainesville, Florida, 30608, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

NOT YET RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

NOT YET RECRUITING

MeSH Terms

Conditions

BehaviorChild Behavior

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Daniel W McNeil, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR
  • Cheryl B McNeil, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary L Davis, CRDH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

November 18, 2023

Study Start

April 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2029

Last Updated

March 16, 2026

Record last verified: 2025-06

Locations