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

University of California Irvine (UCI)

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Parent Training; Behavioral: AIR-P Dental Toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT03003221

2016-3043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 2 patient groups

AIR-P Dental Toolkit

Active Comparator group

Description:

Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.

Treatment:

Behavioral: AIR-P Dental Toolkit

Parent Training

Experimental group

Description:

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.

Treatment:

Behavioral: Parent Training

Behavioral: AIR-P Dental Toolkit