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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003221
• Other study ID #: 2016-3043
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: June 2019

Study information

• Verified date: April 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of California Irvine	Irvine	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Irvine	California State University, Fullerton, Healthy Smiles for Kids of Orange County, Massachusetts General Hospital, Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parenting Stress according to questionnaire	Parent-reported parenting stress according to questionnaire.	Change from Baseline parent-reported parenting stress at 6 months
Other	Perceived Parenting Competence according to questionnaire	Parent-reported perceived parenting competence according to questionnaire.	Change from Baseline parent-reported perceived parenting competence at 6 months
Primary	Frequency of tooth brushing at home	Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.	Change from Baseline frequency of tooth brushing at 6 months
Primary	Child oral health according to standardized measures from visual exam	Dentist ratings of child oral health according to standardized measures from visual exam.	Change from Baseline child oral health at 6 months
Secondary	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.	Change from Baseline child behavior at 6 months
Secondary	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).	Change from Baseline anxiety and behavior at 6 months
Secondary	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.	Change from Baseline behavioral compliance at 6 months
Secondary	Completion of dental visit procedures according to questionnaire	Dentist-reported completion of visit procedures according to questionnaire.	Change from Baseline completion of dental visit procedures at 6 months