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Trial record 91 of 258 for:    Recruiting, Not yet recruiting, Available Studies | "Autistic Disorder"

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

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ClinicalTrials.gov Identifier: NCT03003221
Recruitment Status : Recruiting
First Posted : December 26, 2016
Last Update Posted : October 26, 2018
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

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: AIR-P Dental Toolkit Behavioral: Parent Training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
Study Start Date : December 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.


Other Outcome Measures:
  1. Parenting Stress according to questionnaire [ Time Frame: Change from Baseline parent-reported parenting stress at 6 months ]
    Parent-reported parenting stress according to questionnaire.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003221


Contacts
Contact: Meghan Orr, BM 949-267-0428 orrme@uci.edu
Contact: Taylor Pifher, BA 614-355-7516 Taylor.Pifher@nationwidechildrens.org

Locations
United States, California
University of California Irvine Recruiting
Irvine, California, United States, 92705
Contact: Meghan Orr, BM    949-267-0428    orrme@uci.edu   
Contact: Rachel M Fenning, PhD    949-267-0417    rfenning@uci.edu   
Principal Investigator: Rachel M Fenning, PhD         
Principal Investigator: Robin Steinberg-Epstein, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43081
Contact: Taylor A Pifher, BA    614-355-7516    Taylor.Pifher@nationwidechildrens.org   
Contact: Eric Butter, PhD    614-722-4700    Eric.Butter@nationwidechildrens.org   
Principal Investigator: Eric Butter, PhD         
Sponsors and Collaborators
Rachel Fenning
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

Responsible Party: Rachel Fenning, Assistant Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03003221     History of Changes
Other Study ID Numbers: 2016-3043
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD data beyond collaborating sites (MGH and NCH).

Keywords provided by Rachel Fenning, University of California, Irvine:
Parent training
Dental care

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders