Behavior and Behavior MechanismsDCITNCT06138405
Dental-Child Interaction Training
A study testing Immediate intervention Group in people with Behavior and Behavior Mechanisms and Child Behavior, run by University of Florida at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Behavior and Behavior Mechanisms, Child Behavior
- What is being tested?
- Immediate intervention Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,808 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Apr 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Kimon Divaris
- Recruiting
University of Arkansas
Fayetteville, Arkansas, 72701
Lauren Quetsch
- Recruiting
University of Florida
Gainesville, Florida, 30608
Daniel McNeil, PhD
- Not yet recruiting
West Virginia University
Morgantown, West Virginia, 26506
Christa Lilly
About this study
Official title: Implementing Evidence-based Behavioral Skills in Pediatric Oral Healthcare Providers
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:
Read more
- 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.
- Conditions
- Behavior and Behavior Mechanisms, Child Behavior
- Being tested
- Immediate intervention Group, Delayed intervention (control) Group
- Medical subject headings
- Behavior, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate intervention GroupBehavioural
The immediate intervention group will be video recorded in office and participate in the training workshop and assessment methods two months after.
Delayed intervention (control) GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Delayed intervention (control) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Immediately pre- and post-workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start3 Apr 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,808 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Daniel W McNeil, PhD, Principal investigator, University of FloridaCheryl B McNeil, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138405
- Sponsor's protocol ID
- IRB202202624 - N
- Other IDs
- 1UG3DE032004-01
- Acronym
- DCIT
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Evidence-based Behavioral Skills in Pediatric Oral Healthcare Providers
- ClinicalTrials.gov ID
- NCT06138405
- Acronym / sponsor ID
- DCIT / IRB202202624 - N
- Conditions
- Behavior and Behavior Mechanisms, Child Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,808 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Behavioral: Immediate intervention GroupExperiential, 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. |
| Delayed Intervention Group | Active comparator | Behavioral: Delayed intervention (control) GroupThe delayed intervention group will receive the same experiential, interactive, skills-oriented workshop, but two months after the immediate intervention group. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate intervention GroupThe immediate intervention group will be video recorded in office and participate in the training workshop and assessment methods two months after. | Behavioural | Immediate Intervention Group |
| Delayed intervention (control) GroupThe 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. | Behavioural | Delayed Intervention Group |
Primary outcome
To assess dental providers' usage of DCIT behavioral methods in the training workshop.
Time frame: 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).
1 secondary outcome
To assess dental providers' knowledge of DCIT principles and methods.
Time frame: Immediately pre- and post-workshop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel W McNeil, PhD principal investigator
University of Florida
Cheryl B McNeil, PhD principal investigator
University of Florida
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate intervention Group in people with Behavior and Behavior Mechanisms and Child Behavior, run by University of Florida at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary L Davis, CRDH (352-222-7034, MDavis@dental.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess dental providers' usage of DCIT behavioral methods in the training workshop. (time frame: Immediately pre- and post-workshop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.