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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: AIR-P Dental Toolkit; Behavioral: Parent Training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AIR-P Dental Toolkit; Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.	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.
Experimental: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Stress according to questionnaire	Parent-reported parenting stress according to questionnaire.	Change from Baseline parent-reported parenting stress at 6 months
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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Massachusetts General Hospital; Nationwide Children's Hospital; California State University, Fullerton; Healthy Smiles for Kids of Orange County
• Investigators: Study Chair: Robin Steinberg-Epstein, MD, University of California, Irvine; Principal Investigator: Rachel M Fenning, PhD, University of California-Irvine; California State University-Fullerton; Principal Investigator: Eric Butter, PhD, Nationwide Children's Hospital

Publications and helpful links

General Publications

• Fenning RM, Butter EM, Macklin EA, Norris M, Hammersmith KJ, McKinnon-Bermingham K, Chan J, Stephenson KG, Albright C, Scherr J, Moffitt JM, Lu F, Spaulding R, Guijon J, Hess A, Coury DL, Kuhlthau KA, Steinberg-Epstein R. Parent Training for Dental Care in Underserved Children With Autism: A Randomized Controlled Trial. Pediatrics. 2022 May 1;149(5):e2021050691. doi: 10.1542/peds.2021-050691.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Parent training; Dental care
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 2016-3043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD data beyond collaborating sites (MGH and NCH).