Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
- Conditions
- Autism Spectrum Disorder
- Interventions
- Behavioral: AIR-P Dental ToolkitBehavioral: Parent Training
- Registration Number
- NCT03003221
- Lead Sponsor
- University of California, Irvine
- Brief 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AIR-P Dental Toolkit AIR-P Dental Toolkit Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit. Parent Training Parent Training 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. Parent Training AIR-P Dental Toolkit 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.
- Primary Outcome Measures
Name Time Method Child oral health according to standardized measures from visual exam Change from Baseline child oral health at 6 months Dentist ratings of child oral health according to standardized measures from visual exam.
Frequency of tooth brushing at home Change from Baseline frequency of tooth brushing at 6 months Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
- Secondary Outcome Measures
Name Time Method Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite) Change from Baseline anxiety and behavior at 6 months Child compliance with dental visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite).
Child behavior during tooth brushing at home according to questionnaire Change from Baseline child behavior at 6 months Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire.
Dentist-reported child behavioral compliance during dental office visit as indexed by questionnaire Change from Baseline behavioral compliance at 6 months Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire.
Completion of dental visit procedures according to questionnaire Change from Baseline completion of dental visit procedures at 6 months Dentist-reported completion of visit procedures according to questionnaire.
Trial Locations
- Locations (2)
University of California Irvine
🇺🇸Irvine, California, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States