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

University of California, Irvine119 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

119

Conditions

Autism Spectrum Disorder

Interventions

AIR-P Dental ToolkitBEHAVIORAL

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 TrainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 13 Years

Medical Language ↔ Plain English

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.

Locations (2)

University of California Irvine

Irvine, California, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Frequency of tooth brushing at home

Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.

Time frame: 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.

Time frame: Change from Baseline child oral health at 6 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Change from Baseline completion of dental visit procedures at 6 months

Data from ClinicalTrials.gov

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