Summary

for people ages 3-13 (full criteria)
at Irvine, California and other locations
study started
estimated completion
Robin Steinberg-Epstein Rachel M Fenning

Description

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.

Details

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.

Keywords

Autism Spectrum Disorder Parent training Dental care Disease Autistic Disorder Child Development Disorders, Pervasive AIR-P Dental Toolkit

Eligibility

You can join if…

Open to people ages 3-13

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Irvine
    Irvine California 92705 United States
  • Nationwide Children's Hospital
    Columbus Ohio 43081 United States

Lead Scientists

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rachel Fenning
ID
NCT03003221
Study Type
Interventional
Last Updated