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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AIR-P Dental Toolkit

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

Group Type ACTIVE_COMPARATOR

AIR-P Dental Toolkit

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

AIR-P Dental Toolkit

Intervention Type BEHAVIORAL

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 Training

Intervention Type BEHAVIORAL

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.

Interventions

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AIR-P Dental Toolkit

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.

Intervention Type BEHAVIORAL

Parent Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No