Clinical trial NCT03003221: Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
Official title: Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Parent training
Dental care
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Nationwide Children's Hospital
name: California State University, Fullerton
name: Healthy Smiles for Kids of Orange County
First posted: 2016-12-26
Enrollment: 119
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of tooth brushing at home
timeFrame: Change from Baseline frequency of tooth brushing at 6 months
measure: Child oral health according to standardized measures from visual exam
timeFrame: Change from Baseline child oral health at 6 months
Secondary outcomes:
measure: Child behavior during tooth brushing at home according to questionnaire
timeFrame: Change from Baseline child behavior at 6 months
measure: Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite)
timeFrame: Change from Baseline anxiety and behavior at 6 months
measure: Dentist-reported child behavioral compliance during dental office visit as indexed by questionnaire
timeFrame: Change from Baseline behavioral compliance at 6 months
measure: Completion of dental visit procedures according to questionnaire
timeFrame: Change from Baseline completion of dental visit procedures at 6 months
Other outcomes:
measure: Parenting Stress according to questionnaire
timeFrame: Change from Baseline parent-reported parenting stress at 6 months
measure: Perceived Parenting Competence according to questionnaire
timeFrame: Change from Baseline parent-reported perceived parenting competence at 6 months
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: University of California, Irvine
name: Robin Steinberg-Epstein, MD
role: STUDY_CHAIR
affiliation: University of California-Irvine; California State University-Fullerton
name: Rachel M Fenning, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Eric Butter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.