Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: AIR-P Dental Toolkit
* Behavioral: Parent Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AIR-P Dental Toolkit<br>Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit. | Behavioral: AIR-P Dental Toolkit<br>* 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.<br>|
| Experimental: Parent Training<br>Families randomized to the Parent Training condition will be provided with the AIR-P Dental Toolkit and a 10-week behavioral parent-training intervention with additional booster sessions. | Behavioral: AIR-P Dental Toolkit<br>* 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.<br>Behavioral: Parent Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of tooth brushing at home | Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week. | Change from Baseline frequency of tooth brushing at 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. | Change from Baseline child oral health at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline child behavior at 6 months | 
| Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite) | Child compliance with dental visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite). | Change from Baseline anxiety and behavior at 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. | Change from Baseline behavioral compliance at 6 months | 
| Completion of dental visit procedures according to questionnaire | Dentist-reported completion of visit procedures according to questionnaire. | Change from Baseline completion of dental visit procedures at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parent training, Dental care