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

NCT03003221 | Completed

• 1 other identifier: 2016-3043
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Parent training; Dental care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Child behavior during tooth brushing at home 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)

  Change from Baseline anxiety and behavior at 6 months

• Dentist-reported child behavioral compliance during dental office visit as indexed by questionnaire

  Change from Baseline behavioral compliance at 6 months

• Completion of dental visit procedures according to questionnaire

  Change from Baseline completion of dental visit procedures at 6 months

Other Outcomes (2)

• Parenting Stress according to questionnaire

  Change from Baseline parent-reported parenting stress at 6 months

• Perceived Parenting Competence according to questionnaire

  Change from Baseline parent-reported perceived parenting competence at 6 months

Study Arms (2)

AIR-P Dental Toolkit

ACTIVE COMPARATOR

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

Behavioral: AIR-P Dental Toolkit

Parent Training

EXPERIMENTAL

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; Behavioral: Parent Training

Interventions

AIR-P Dental Toolkit 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.

AIR-P Dental Toolkit; Parent Training

Parent Training 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.

Parent Training

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Massachusetts General Hospital: collaborator
• Nationwide Children's Hospital: collaborator
• California State University, Fullerton: collaborator
• Healthy Smiles for Kids of Orange County: collaborator

Study Sites (2)

University of California Irvine

Irvine, California, 92705, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43081, United States

Location

Related Publications (1)

• 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.

  PMID: 35211746 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Robin Steinberg-Epstein, MD

  University of California, Irvine

  STUDY CHAIR

• Rachel M Fenning, PhD

  University of California-Irvine; California State University-Fullerton

  PRINCIPAL INVESTIGATOR

• Eric Butter, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 26, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)