<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03003221</url>
  </required_header>
  <id_info>
    <org_study_id>2016-3043</org_study_id>
    <nct_id>NCT03003221</nct_id>
  </id_info>
  <brief_title>Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder</brief_title>
  <official_title>Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>California State University, Fullerton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Healthy Smiles for Kids of Orange County</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial (at sites) comparing the efficacy of the established AIR-P&#xD;
      Dental Toolkit (control condition) to a combined regimen involving the Dental Toolkit and&#xD;
      parent-mediated behavioral intervention (intervention condition) to improve home dental care,&#xD;
      oral health outcomes, and dental office visit experiences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participation in routine dental care is a significant challenge for children with autism&#xD;
      spectrum disorder (ASD) due to a variety of factors, including considerations related to ASD&#xD;
      symptoms and associated anxiety and behavioral difficulties. Lack of routine, effective&#xD;
      dental care has contributed to a substantial unmet healthcare need for children with ASD, who&#xD;
      are at increased risk for excessive plaque, caries, and oral infections.&#xD;
&#xD;
      The purpose of this study is to test a parent-training intervention designed to improve home&#xD;
      dental hygiene, compliance with dental office visits, and oral health outcomes in children&#xD;
      with autism spectrum disorder. Families of children with an existing diagnosis of ASD will be&#xD;
      recruited for participation. All families will receive the Autism Intervention Research&#xD;
      Network on Physical Health (AIR-P) Dental Toolkit, which is designed to provide parents with&#xD;
      guidance and information about dental care and support strategies for children with ASD. Some&#xD;
      families will also participate in a 10-week behavioral parent-training intervention focused&#xD;
      on improving home dental care and dental office visit experiences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of tooth brushing at home</measure>
    <time_frame>Change from Baseline frequency of tooth brushing at 6 months</time_frame>
    <description>Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child oral health according to standardized measures from visual exam</measure>
    <time_frame>Change from Baseline child oral health at 6 months</time_frame>
    <description>Dentist ratings of child oral health according to standardized measures from visual exam.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child behavior during tooth brushing at home according to questionnaire</measure>
    <time_frame>Change from Baseline child behavior at 6 months</time_frame>
    <description>Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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)</measure>
    <time_frame>Change from Baseline anxiety and behavior at 6 months</time_frame>
    <description>Child compliance with dental visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dentist-reported child behavioral compliance during dental office visit as indexed by questionnaire</measure>
    <time_frame>Change from Baseline behavioral compliance at 6 months</time_frame>
    <description>Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of dental visit procedures according to questionnaire</measure>
    <time_frame>Change from Baseline completion of dental visit procedures at 6 months</time_frame>
    <description>Dentist-reported completion of visit procedures according to questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Parenting Stress according to questionnaire</measure>
    <time_frame>Change from Baseline parent-reported parenting stress at 6 months</time_frame>
    <description>Parent-reported parenting stress according to questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Parenting Competence according to questionnaire</measure>
    <time_frame>Change from Baseline parent-reported perceived parenting competence at 6 months</time_frame>
    <description>Parent-reported perceived parenting competence according to questionnaire.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>AIR-P Dental Toolkit</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AIR-P Dental Toolkit</intervention_name>
    <description>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.</description>
    <arm_group_label>AIR-P Dental Toolkit</arm_group_label>
    <arm_group_label>Parent Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent Training</intervention_name>
    <description>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.</description>
    <arm_group_label>Parent Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking families of children ages 3 to 13 years and 11 months.&#xD;
&#xD;
          -  Current diagnosis of ASD confirmed by baseline assessment.&#xD;
&#xD;
          -  Parent-reported difficulty participating in dental care.&#xD;
&#xD;
          -  Confirmed absence of dental screenings or exams/visits within the previous 6 months.&#xD;
&#xD;
          -  Underserved status as defined by Medicaid eligibility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who present with an acute dental condition requiring emergency treatment.&#xD;
&#xD;
          -  Children who are currently taking, or have recently discontinued, medications that&#xD;
             affect oral and gingival health.&#xD;
&#xD;
          -  Anything that, in the opinion of the Site Principal Investigator, would place the&#xD;
             subject at unwarranted risk or materially reduce their contribution to the trial's&#xD;
             aims due to inability or refusal to adhere to trial procedures and follow-up.&#xD;
&#xD;
        Families will be asked to refrain from participating in any non-study adaptive behavior&#xD;
        interventions or therapies focused on dental hygiene. Families will also be asked not to&#xD;
        participate in any non-study dental screenings or exams for the duration of the&#xD;
        investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Steinberg-Epstein, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of California, Irvine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rachel M Fenning, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California-Irvine; California State University-Fullerton</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric Butter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>April 9, 2021</last_update_submitted>
  <last_update_submitted_qc>April 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parent training</keyword>
  <keyword>Dental care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD data beyond collaborating sites (MGH and NCH).</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03003221
org study id: 2016-3043
nct id: NCT03003221
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Frequency of tooth brushing at home
time frame: Change from Baseline frequency of tooth brushing at 6 months
description: Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
measure: Child oral health according to standardized measures from visual exam
time frame: Change from Baseline child oral health at 6 months
description: Dentist ratings of child oral health according to standardized measures from visual exam.
measure: Child behavior during tooth brushing at home according to questionnaire
time frame: Change from Baseline child behavior at 6 months
description: Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire.
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)
time frame: Change from Baseline anxiety and behavior at 6 months
description: Child compliance with dental visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite).
measure: Dentist-reported child behavioral compliance during dental office visit as indexed by questionnaire
time frame: Change from Baseline behavioral compliance at 6 months
description: Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire.
measure: Completion of dental visit procedures according to questionnaire
time frame: Change from Baseline completion of dental visit procedures at 6 months
description: Dentist-reported completion of visit procedures according to questionnaire.
measure: Parenting Stress according to questionnaire
time frame: Change from Baseline parent-reported parenting stress at 6 months
description: Parent-reported parenting stress according to questionnaire.
measure: Perceived Parenting Competence according to questionnaire
time frame: Change from Baseline parent-reported perceived parenting competence at 6 months
description: Parent-reported perceived parenting competence according to questionnaire.
arm group label: AIR-P Dental Toolkit
arm group type: Active Comparator
description: Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
arm group label: Parent Training
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: AIR-P Dental Toolkit
description: 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.
arm group label: AIR-P Dental Toolkit
arm group label: Parent Training
intervention type: Behavioral
intervention name: Parent Training
description: 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.
arm group label: Parent Training
criteria: 
gender: All
minimum age: 3 Years
maximum age: 13 Years
healthy volunteers: No
last name: Robin Steinberg-Epstein, MD
role: Study Chair
affiliation: University of California, Irvine
last name: Rachel M Fenning, PhD
role: Principal Investigator
affiliation: University of California-Irvine; California State University-Fullerton
last name: Eric Butter, PhD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: No
ipd description: No plan to share IPD data beyond collaborating sites (MGH and NCH).