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

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ClinicalTrials.gov Identifier: NCT03003221
Recruitment Status : Active, not recruiting
First Posted : December 26, 2016
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Massachusetts General Hospital
Nationwide Children's Hospital
California State University, Fullerton
Healthy Smiles for Kids of Orange County
Information provided by (Responsible Party):
Rachel Fenning, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE December 26, 2016
Last Update Posted Date February 8, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2016)
  • Frequency of tooth brushing at home [ Time Frame: Change from Baseline frequency of tooth brushing at 6 months ]
    Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
  • Child oral health according to standardized measures from visual exam [ Time Frame: Change from Baseline child oral health at 6 months ]
    Dentist ratings of child oral health according to standardized measures from visual exam.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03003221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
  • Child behavior during tooth brushing at home according to questionnaire [ Time Frame: Change from Baseline child behavior at 6 months ]
    Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire.
  • Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite) [ Time Frame: Change from Baseline anxiety and behavior at 6 months ]
    Child compliance with dental visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite).
  • Dentist-reported child behavioral compliance during dental office visit as indexed by questionnaire [ Time Frame: Change from Baseline behavioral compliance at 6 months ]
    Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire.
  • Completion of dental visit procedures according to questionnaire [ Time Frame: Change from Baseline completion of dental visit procedures at 6 months ]
    Dentist-reported completion of visit procedures according to questionnaire.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2016)
  • Child behavior during tooth brushing at home according to questionnaire [ Time Frame: Change from Baseline child behavior at 6 months ]
    Parent-reported child behavioral compliance with home dental hygiene according to questionnaire.
  • Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite) [ Time Frame: Change from Baseline anxiety and behavior at 6 months ]
    Child compliance with dental visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite).
  • Dentist-reported child behavioral compliance during dental office visit as indexed by questionnaire [ Time Frame: Change from Baseline behavioral compliance at 6 months ]
    Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire.
  • Completion of dental visit procedures according to questionnaire [ Time Frame: Change from Baseline completion of dental visit procedures at 6 months ]
    Dentist-reported completion of visit procedures according to questionnaire.
Current Other Pre-specified Outcome Measures
 (submitted: December 23, 2016)
  • Parenting Stress according to questionnaire [ Time Frame: Change from Baseline parent-reported parenting stress at 6 months ]
    Parent-reported parenting stress according to questionnaire.
  • Perceived Parenting Competence according to questionnaire [ Time Frame: Change from Baseline parent-reported perceived parenting competence at 6 months ]
    Parent-reported perceived parenting competence according to questionnaire.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
Official Title  ICMJE Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: AIR-P Dental Toolkit
    Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
    Intervention: Behavioral: AIR-P Dental Toolkit
  • 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.
    Interventions:
    • Behavioral: AIR-P Dental Toolkit
    • Behavioral: Parent Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 24, 2018)
118
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2016)
85
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03003221
Other Study ID Numbers  ICMJE 2016-3043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share IPD data beyond collaborating sites (MGH and NCH).
Responsible Party Rachel Fenning, University of California, Irvine
Study Sponsor  ICMJE Rachel Fenning
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Nationwide Children's Hospital
  • California State University, Fullerton
  • Healthy Smiles for Kids of Orange County
Investigators  ICMJE
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
PRS Account University of California, Irvine
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP