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Completed
NCT03003221
Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
Conditions: Autism Spectrum Disorder
Sex: All
Ages: 3 Years – 13 Years
Healthy volunteers: No
Phase: NA
Enrollment: 119
Sponsor: University of California, Irvine
Location: University of California Irvine Irvine California
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT03003221). StuddyBuddy aggregates publicly available trial information.