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

Primary Purpose

Autism Spectrum Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AIR-P Dental Toolkit

Parent Training

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Parent training, Dental care

Eligibility Criteria

3 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California Irvine
Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

AIR-P Dental Toolkit

Parent Training

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Frequency of tooth brushing at home

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

Dentist ratings of child oral health according to standardized measures from visual exam.

Secondary Outcome Measures

Child behavior during tooth brushing at home according to questionnaire

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)

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

Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire.

Completion of dental visit procedures according to questionnaire

Dentist-reported completion of visit procedures according to questionnaire.

Full Information

NCT ID

NCT03003221

First Posted

December 20, 2016

Last Updated

April 9, 2021

Sponsor

University of California, Irvine

Collaborators

Massachusetts General Hospital, Nationwide Children's Hospital, California State University, Fullerton, Healthy Smiles for Kids of Orange County

1. Study Identification

Unique Protocol Identification Number

NCT03003221

Brief Title

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 2016 (undefined)

Primary Completion Date

June 2019 (Actual)

Study Completion Date

June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Irvine

Collaborators

Massachusetts General Hospital, Nationwide Children's Hospital, California State University, Fullerton, Healthy Smiles for Kids of Orange County

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Parent training, Dental care

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIR-P Dental Toolkit

Arm Type

Active Comparator

Arm Description

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

Arm Title

Parent Training

Arm Type

Experimental

Arm 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(s)

AIR-P Dental Toolkit

Intervention 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.

Intervention Type

Behavioral

Intervention Name(s)

Parent Training

Intervention 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.

Primary Outcome Measure Information:

Title

Frequency of tooth brushing at home

Description

Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.

Time Frame

Change from Baseline frequency of tooth brushing at 6 months

Title

Child oral health according to standardized measures from visual exam

Description

Dentist ratings of child oral health according to standardized measures from visual exam.

Time Frame

Change from Baseline child oral health at 6 months

Secondary Outcome Measure Information:

Title

Child behavior during tooth brushing at home according to questionnaire

Description

Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire.

Time Frame

Change from Baseline child behavior at 6 months

Title

Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite)

Description

Child compliance with dental 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

Title

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

Description

Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire.

Time Frame

Change from Baseline behavioral compliance at 6 months

Title

Completion of dental visit procedures according to questionnaire

Description

Dentist-reported completion of visit procedures according to questionnaire.

Time Frame

Change from Baseline completion of dental visit procedures at 6 months

Other Pre-specified Outcome Measures:

Title

Parenting Stress according to questionnaire

Description

Parent-reported parenting stress according to questionnaire.

Time Frame

Change from Baseline parent-reported parenting stress at 6 months

Title

Perceived Parenting Competence according to questionnaire

Description

Parent-reported perceived parenting competence according to questionnaire.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robin Steinberg-Epstein, MD

Organizational Affiliation

University of California, Irvine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Rachel M Fenning, PhD

Organizational Affiliation

University of California-Irvine; California State University-Fullerton

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eric Butter, PhD

Organizational Affiliation

Nationwide Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California Irvine

City

Irvine

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43081

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share IPD data beyond collaborating sites (MGH and NCH).

Citations:

PubMed Identifier

35211746

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.

Results Reference

derived

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

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