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RecruitingNCT06138405DCITUpdated Aug 5, 2026

Dental-Child Interaction Training

An interventional study of Immediate intervention Group and Delayed intervention (control) Group in Behavior and Behavior Mechanisms and Child Behavior, sponsored by University of Florida. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Primary conditionChild BehaviorRegistry: BehaviorReclassifiedWhy we changed it
Registry
Behavior — the first condition term the registry derived for this study.
ClinicalTrials.gg
Child Behavior
Why
  1. The study's listed conditions name Child Behavior, a narrower term within Behavior.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Florida · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
5,808
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Behavior and Behavior Mechanisms
  • Child Behavior

Browse trials for

03

In context

Child Behavior Reclassified

224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.

This study's planned enrollment of 5,808 is above the median of 140 across 197 interventional studies indexed under Child Behavior.

Browse Child Behavior studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Compared within Child Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,808 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Immediate intervention Group

  • Active comparator
    Delayed Intervention Group

    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

  • BehavioralImmediate intervention Group

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

  • BehavioralDelayed 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.

06

What researchers measure

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).

    Time frame: Immediately pre- and post-workshop

Secondary outcomes

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

    Providers will be tested before and after the training on basic knowledge and principles and application of Dental-Child Interaction Training (DCIT) skills using a 20-item self-report instrument to assess providers' knowledge and level of understanding of DCIT behavioral principles. Outcome measured by the Dental Provider DCIT Skills Knowledge assessment. A total of 20 questions using a multiple choice and free response format.

    Time frame: Immediately pre- and post-workshop

Other outcomes

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

    Acceptability is a crucial aspect of whether dental providers will implement the skills they have learned. Outcome measured by providers' rating of likeliness of adapting DCIT skills in their dental practices/clinics using 40-item Usage Rating Profile - Intervention Revised (URP-IR) and 6 month post training Focus group.

    Time frame: Immediately post- workshop and again two and 6 months post workshop

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

    Direct observation during a pediatric dental appointment in the dental provider's practice/clinical setting to determine 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 in all provider-child interactions. This objective provides an evaluation of whether dental providers actually acquire and demonstrate skill change in their practices. Outcome measured by observation of in-office video-taped interactions between dental provider and children using Dental-Dyadic Parent-Child Interaction Coding System (D-DPICS).

    Time frame: 2 months pre-workshop to 2 months post-workshop

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

    Coded observations and ratings of child behavior (e.g., adherence, positivity, and fearfulness) during dental treatment with providers using the D-DPICS to evaluate the impact of DCIT behavioral methods on child behavior. Outcome measured by observation of in-office video-taped interactions between dental provider and children using Dental-Dyadic Parent-Child Interaction Coding System (D-DPICS). In addition, child behavior ratings using the Frankl scale of child cooperation during the dental appointment.

    Time frame: 2 months pre-workshop to 2 months post-workshop

07

Study locations

2 of 4 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06138405
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Apr 3, 2026
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Aug 5, 2026

Study contacts

Mary L Davis, CRDH
Contact
MDavis@dental.ufl.edu
352-222-7034
Daniel W McNeil, PhD
principal investigator · University of Florida
Cheryl B McNeil, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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