Autism Spectrum DisorderNCT03003221
Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
A study testing AIR-P Dental Toolkit and Parent Training in people with Autism Spectrum Disorder, run by University of California, Irvine at 2 sites in United States.
Trial summary
A randomized controlled trial (at sites) comparing the efficacy of the established AIR-P Dental Toolkit (control condition) to a combined regimen involving the Dental Toolkit and parent-mediated behavioral intervention (intervention condition) to improve home dental care, oral health outcomes, and dental office visit… Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- AIR-P Dental Toolkit and Parent Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- English-speaking families of children ages 3 to 13 years and 11 months.
- Current diagnosis of ASD confirmed by baseline assessment.
- Parent-reported difficulty participating in dental care.
- Confirmed absence of dental screenings or exams/visits within the previous 6 months.
- Underserved status as defined by Medicaid eligibility.
Who cannot join
- Children who present with an acute dental condition requiring emergency treatment.
- Children who are currently taking, or have recently discontinued, medications that affect oral and gingival health.
- Anything that, in the opinion of the Site Principal Investigator, would place the subject at unwarranted risk or materially reduce their contribution to the trial's aims due to inability or refusal to adhere to trial procedures and follow-up.
- Families will be asked to refrain from participating in any non-study adaptive behavior interventions or therapies focused on dental hygiene. Families will also be asked not to participate in any non-study dental screenings or exams for the duration of the investigation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nationwide Children's Hospital
Columbus, Ohio, 43081
University of California Irvine
Irvine, California, 92705
About this study
A randomized controlled trial (at sites) comparing the efficacy of the established AIR-P Dental Toolkit (control condition) to a combined regimen involving the Dental Toolkit and parent-mediated behavioral intervention (intervention condition) to improve home dental care, oral health outcomes, and dental office visit experiences.
Read the detailed description
Participation in routine dental care is a significant challenge for children with autism spectrum disorder (ASD) due to a variety of factors, including considerations related to ASD symptoms and associated anxiety and behavioral difficulties. Lack of routine, effective dental care has contributed to a substantial unmet healthcare need for children with ASD, who are at increased risk for excessive plaque, caries, and oral infections.
The purpose of this study is to test a parent-training intervention designed to improve home dental hygiene, compliance with dental office visits, and oral health outcomes in children with autism spectrum disorder. Families of children with an existing diagnosis of ASD will be recruited for participation. All families will receive the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit, which is designed to provide parents with guidance and information about dental care and support strategies for children with ASD. Some families will also participate in a 10-week behavioral parent-training intervention focused on improving home dental care and dental office visit experiences.
- Conditions
- Autism Spectrum Disorder
- Being tested
- AIR-P Dental Toolkit, Parent Training
- Keywords
- Parent training, Dental care
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIR-P Dental ToolkitBehavioural
The AIR-P Dental Toolkit is designed to provide caregivers with guidance and information related to dental care and support strategies for children with autism spectrum disorder.
Parent TrainingBehavioural
The parent-training intervention integrates strategies shown to be efficacious for: 1) improving adherence to dental care, 2) enhancing dental experiences for children with neurotypical development and high levels of dental fear, and 3) evidence-based behavioral techniques established for children with autism spectrum disorder.
| Study group | Role | What they receive |
|---|---|---|
| AIR-P Dental Toolkit | Active comparator | Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit. Receives: Behavioral: AIR-P Dental Toolkit |
| Parent Training | Experimental | Families randomized to the Parent Training condition will be provided with the AIR-P Dental Toolkit and individual behavioral parent training comprised of 7 core in-person sessions, including a home visit and a dental office coach, and 4 phone booster sessions. Receives: Behavioral: AIR-P Dental Toolkit; Behavioral: Parent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Tooth Brushing at Home
Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Measured: Difference in brushing frequency between Baseline and 6 months
Frequency of Tooth Brushing at Home
Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Measured: Difference in brushing frequency between Baseline and 3 months
Child Oral Health According to Standardized Measures From Visual Exam
Dentist ratings of child oral health according to standardized measures from visual exam. Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface). Higher scores index greater visual plaque. VPI Score =Total Score (Max + Mand) / # Surfaces Examined
Measured: Difference in oral health between Baseline and 6 months
Child Oral Health According to Standardized Measures From Visual Exam
Dentist ratings of child oral health according to standardized measures from visual exam. Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface). Higher scores index greater visual plaque. VPI Score =Total Score (Max + Mand) / # Surfaces Examined
Measured: Difference in oral health between Baseline child and 3 months
Secondary outcomes (9)
Child Behavior During Tooth Brushing at Home According to Questionnaire
Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire. Parents reported on the occurrence and severity of 8 behavior problems during the past week's oral hygiene activities (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Higher scores index greater behavior problems during home oral hygiene. Items were averaged to produce a single score (α = 0.91).
Measured: Difference in child behavior between Baseline and 6 months
Child Behavior During Tooth Brushing at Home According to Questionnaire
Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire. Parents reported on the occurrence and severity of 8 behavior problems during the past week's oral hygiene activities (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Higher scores index greater behavior problems during home oral hygiene. Items were averaged to produce a single score (α = 0.91).
Measured: Difference in child behavior between Baseline and 3 months
Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT) to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The scale is from 0 to 32, with 32 being the worst score.
Measured: Difference in Caries between Baseline and 6 months
Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F).The scale range is 0-32 with 32 being worse.
Measured: Difference in Caries between Baseline and 3 months
Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The d2/D2 code represents clinically detectable cavitated lesions. The scale range is 0-32 with 32 being worse.
Measured: Difference in decayed teeth between baseline to 6 months
Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The d2/D2 code represents clinically detectable cavitated lesions. The scale range 0-32 with 32 being worse.
Measured: Difference in decayed teeth between baseline and 3 months
Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales)
Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite). The scale is 0-5, 5 representing worse.
Measured: Difference in anxiety and behavior between Baseline and 6 months
Dentist-reported Child Behavioral Compliance During Dental Office Visit as Indexed by Questionnaire
Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire. Dentists reported on the occurrence and severity of 8 behavior problems during the dental visit (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Items were averaged to produce a single score.
Measured: Difference in behavioral compliance between baseline and at 6 months
Completion of Dental Visit Procedures According to Questionnaire
Dentist-reported completion of visit procedures according to questionnaire (severity of behavior during visit procedures). Behavior problems rated using a 0 to 9 scale (0 = no problem, 9 = severe problem). 9 represents a worse outcome.
Measured: Difference between completion of dental visit procedures at baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Nationwide Children's Hospital, California State University, Fullerton, Healthy Smiles for Kids of Orange County
- Responsible party
- Principal investigator, Coleen Cunningham, University of California, Irvine
- Investigators
- Robin Steinberg-Epstein, MD, Study chair, University of California, IrvineRachel M Fenning, PhD, Principal investigator, University of California-Irvine; California State University-FullertonEric Butter, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003221
- Sponsor's protocol ID
- 20163043
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2016
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD data beyond collaborating sites (MGH and NCH).
Publications
Fenning RM, Butter EM, Macklin EA, Norris M, Hammersmith KJ, McKinnon-Bermingham K, Chan J, Stephenson KG, Albright C, Scherr J, Moffitt JM, Lu F, Spaulding R, Guijon J, Hess A, Coury DL, Kuhlthau KA, Steinberg-Epstein R. Parent Training for Dental Care in Underserved Children With Autism: A Randomized Controlled Trial. Pediatrics. 2022 May 1;149(5):e2021050691. doi: 10.1542/peds.2021-050691.
PubMed 35211746
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03003221
- Acronym / sponsor ID
- 20163043
- Conditions
- Autism Spectrum Disorder
- Keywords
- Parent training, Dental care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Nationwide Children's Hospital, California State University, Fullerton, Healthy Smiles for Kids of Orange County
- Study start
- Dec 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial (at sites) comparing the efficacy of the established AIR-P Dental Toolkit (control condition) to a combined regimen involving the Dental Toolkit and parent-mediated behavioral intervention (intervention condition) to improve home dental care, oral health outcomes, and dental office visit experiences.
Detailed description
Participation in routine dental care is a significant challenge for children with autism spectrum disorder (ASD) due to a variety of factors, including considerations related to ASD symptoms and associated anxiety and behavioral difficulties. Lack of routine, effective dental care has contributed to a substantial unmet healthcare need for children with ASD, who are at increased risk for excessive plaque, caries, and oral infections.
The purpose of this study is to test a parent-training intervention designed to improve home dental hygiene, compliance with dental office visits, and oral health outcomes in children with autism spectrum disorder. Families of children with an existing diagnosis of ASD will be recruited for participation. All families will receive the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit, which is designed to provide parents with guidance and information about dental care and support strategies for children with ASD. Some families will also participate in a 10-week behavioral parent-training intervention focused on improving home dental care and dental office visit experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIR-P Dental Toolkit | Active comparator | Behavioral: AIR-P Dental ToolkitFamilies will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit. |
| Parent Training | Experimental | Behavioral: AIR-P Dental Toolkit, Behavioral: Parent TrainingFamilies randomized to the Parent Training condition will be provided with the AIR-P Dental Toolkit and individual behavioral parent training comprised of 7 core in-person sessions, including a home visit and a dental office coach, and 4 phone booster sessions. |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- English-speaking families of children ages 3 to 13 years and 11 months.
- Current diagnosis of ASD confirmed by baseline assessment.
- Parent-reported difficulty participating in dental care.
- Confirmed absence of dental screenings or exams/visits within the previous 6 months.
- Underserved status as defined by Medicaid eligibility.
Key exclusion criteria (4 listed)
- Children who present with an acute dental condition requiring emergency treatment.
- Children who are currently taking, or have recently discontinued, medications that affect oral and gingival health.
- Anything that, in the opinion of the Site Principal Investigator, would place the subject at unwarranted risk or materially reduce their contribution to the trial's aims due to inability or refusal to adhere to trial procedures and follow-up.
- Families will be asked to refrain from participating in any non-study adaptive behavior interventions or therapies focused on dental hygiene. Families will also be asked not to participate in any non-study dental screenings or exams for the duration of the investigation.
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 |
|---|---|---|
| AIR-P Dental ToolkitThe AIR-P Dental Toolkit is designed to provide caregivers with guidance and information related to dental care and support strategies for children with autism spectrum disorder. | Behavioural | AIR-P Dental Toolkit, Parent Training |
| Parent TrainingThe parent-training intervention integrates strategies shown to be efficacious for: 1) improving adherence to dental care, 2) enhancing dental experiences for children with neurotypical development and high levels of dental fear, and 3) evidence-based behavioral techniques established for children with autism spectrum disorder. | Behavioural | Parent Training |
Primary outcome
Frequency of Tooth Brushing at Home
Time frame: Difference in brushing frequency between Baseline and 6 months
Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Frequency of Tooth Brushing at Home
Time frame: Difference in brushing frequency between Baseline and 3 months
Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Child Oral Health According to Standardized Measures From Visual Exam
Time frame: Difference in oral health between Baseline and 6 months
Dentist ratings of child oral health according to standardized measures from visual exam. Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface). Higher scores index greater visual plaque. VPI Score =Total Score (Max + Mand) / # Surfaces Examined
Child Oral Health According to Standardized Measures From Visual Exam
Time frame: Difference in oral health between Baseline child and 3 months
Dentist ratings of child oral health according to standardized measures from visual exam. Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface). Higher scores index greater visual plaque. VPI Score =Total Score (Max + Mand) / # Surfaces Examined
9 secondary outcomes
Child Behavior During Tooth Brushing at Home According to Questionnaire
Time frame: Difference in child behavior between Baseline and 6 months
Child Behavior During Tooth Brushing at Home According to Questionnaire
Time frame: Difference in child behavior between Baseline and 3 months
Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
Time frame: Difference in Caries between Baseline and 6 months
Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
Time frame: Difference in Caries between Baseline and 3 months
Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
Time frame: Difference in decayed teeth between baseline to 6 months
Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
Time frame: Difference in decayed teeth between baseline and 3 months
Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales)
Time frame: Difference in anxiety and behavior between Baseline and 6 months
Dentist-reported Child Behavioral Compliance During Dental Office Visit as Indexed by Questionnaire
Time frame: Difference in behavioral compliance between baseline and at 6 months
Completion of Dental Visit Procedures According to Questionnaire
Time frame: Difference between completion of dental visit procedures at baseline and at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35211746Fenning RM, Butter EM, Macklin EA, Norris M, Hammersmith KJ, McKinnon-Bermingham K, Chan J, Stephenson KG, Albright C, Scherr J, Moffitt JM, Lu F, Spaulding R, Guijon J, Hess A, Coury DL, Kuhlthau KA, Steinberg-Epstein R. Parent Training for Dental Care in Underserved Children With Autism: A Randomized Controlled Trial. Pediatrics. 2022 May 1;149(5):e2021050691. doi: 10.1542/peds.2021-050691.
- Individual participant dataSharing planned: No. No plan to share IPD data beyond collaborating sites (MGH and NCH).
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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. This study is not recruiting at the moment.
Robin Steinberg-Epstein, MD study chair
University of California, Irvine
Rachel M Fenning, PhD principal investigator
University of California-Irvine; California State University-Fullerton
Eric Butter, PhD principal investigator
Nationwide Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIR-P Dental Toolkit and Parent Training in people with Autism Spectrum Disorder, run by University of California, Irvine at 2 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 5 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: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Tooth Brushing at Home (time frame: Difference in brushing frequency between Baseline and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003221, which also lists 1 linked publication.
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 15 Jun 2026.