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Completed

NCT Number: NCT03003221

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Irvine, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AIR-P Dental Toolkit

Behavioral

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.

Parent Training

Behavioral

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 outcomes

  1. Frequency of Tooth Brushing at Home

    Time frame: Difference in brushing frequency between Baseline and 6 months

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

  2. Frequency of Tooth Brushing at Home

    Time frame: Difference in brushing frequency between Baseline and 3 months

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

  3. Child Oral Health According to Standardized Measures From Visual Exam

    Time frame: Difference in oral health between Baseline and 6 months

    Dentist ratings of child oral health according to standardized measures from visual exam. Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface). Higher scores index greater visual plaque. VPI Score =Total Score (Max + Mand) / # Surfaces Examined

  4. Child Oral Health According to Standardized Measures From Visual Exam

    Time frame: Difference in oral health between Baseline child and 3 months

    Dentist ratings of child oral health according to standardized measures from visual exam. Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface). Higher scores index greater visual plaque. VPI Score =Total Score (Max + Mand) / # Surfaces Examined

Secondary outcomes

  1. Child Behavior During Tooth Brushing at Home According to Questionnaire

    Time frame: Difference in child behavior between Baseline and 6 months

    Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire. Parents reported on the occurrence and severity of 8 behavior problems during the past week's oral hygiene activities (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Higher scores index greater behavior problems during home oral hygiene. Items were averaged to produce a single score (α = 0.91).

  2. Child Behavior During Tooth Brushing at Home According to Questionnaire

    Time frame: Difference in child behavior between Baseline and 3 months

    Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire. Parents reported on the occurrence and severity of 8 behavior problems during the past week's oral hygiene activities (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Higher scores index greater behavior problems during home oral hygiene. Items were averaged to produce a single score (α = 0.91).

  3. Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.

    Time frame: Difference in Caries between Baseline and 6 months

    Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT) to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The scale is from 0 to 32, with 32 being the worst score.

  4. Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.

    Time frame: Difference in Caries between Baseline and 3 months

    Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F).The scale range is 0-32 with 32 being worse.

  5. Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.

    Time frame: Difference in decayed teeth between baseline to 6 months

    Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The d2/D2 code represents clinically detectable cavitated lesions. The scale range is 0-32 with 32 being worse.

  6. Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.

    Time frame: Difference in decayed teeth between baseline and 3 months

    Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The d2/D2 code represents clinically detectable cavitated lesions. The scale range 0-32 with 32 being worse.

  7. Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales)

    Time frame: Difference in anxiety and behavior between Baseline and 6 months

    Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite). The scale is 0-5, 5 representing worse.

  8. Dentist-reported Child Behavioral Compliance During Dental Office Visit as Indexed by Questionnaire

    Time frame: Difference in behavioral compliance between baseline and at 6 months

    Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire. Dentists reported on the occurrence and severity of 8 behavior problems during the dental visit (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Items were averaged to produce a single score.

  9. Completion of Dental Visit Procedures According to Questionnaire

    Time frame: Difference between completion of dental visit procedures at baseline and at 6 months

    Dentist-reported completion of visit procedures according to questionnaire (severity of behavior during visit procedures). Behavior problems rated using a 0 to 9 scale (0 = no problem, 9 = severe problem). 9 represents a worse outcome.

Other outcomes

  1. Family Impact Questionnaire (FIQ)

    Time frame: Difference in parent-reported parenting stress at baseline and at 6 months

    Parenting stress associated with parenting the target autistic child. Negative Impact Composite range 0-82; higher scores index greater parenting stress.

  2. Parenting Sense of Competence Scale (PSOC)

    Time frame: Difference in parent-reported perceived parenting competence between baseline and 6 months

    Parent-reported perceived parenting self-efficacy according to questionnaire, total score; range 16-96; higher scores index greater parenting self-efficacy.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2016
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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