Autism Spectrum Disorder
Conditions
Keywords
Parent training, Dental care
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.
Interventions
BEHAVIORALAIR-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.
BEHAVIORALParent 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.
Sponsors
University of California, Irvine
Massachusetts General Hospital
Nationwide Children's Hospital
California State University, Fullerton
Healthy Smiles for Kids of Orange County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Tooth Brushing at Home | 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. |
| Child Oral Health According to Standardized Measures From Visual Exam | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Behavior During Tooth Brushing at Home According to Questionnaire | 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). |
| Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index. | 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. |
| Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index. | 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. |
| Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales) | 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. |
| Dentist-reported Child Behavioral Compliance During Dental Office Visit as Indexed by Questionnaire | 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. |
| Completion of Dental Visit Procedures According to Questionnaire | 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. |
Countries
United States
Contacts
STUDY_CHAIRRobin Steinberg-Epstein, MD
University of California, Irvine
PRINCIPAL_INVESTIGATORRachel M Fenning, PhD
University of California-Irvine; California State University-Fullerton
PRINCIPAL_INVESTIGATOREric Butter, PhD
Nationwide Children's Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 7.3 years STANDARD_DEVIATION 2.6 |
| Annual gross family income <$15,000 | 17 Participants |
| Annual gross family income $15,000-$24,999 | 27 Participants |
| Annual gross family income $25,000-$34,999 | 25 Participants |
| Annual gross family income $35,000-$49,999 | 20 Participants |
| Annual gross family income $50,000-$74,999 | 13 Participants |
| Annual gross family income ≥$75,000 | 2 Participants |
| Annual gross family income Unknown or not reported | 5 Participants |
| Behavior problem severity during home oral hygiene | 2.85 units on a scale STANDARD_DEVIATION 2.35 |
| Child age at first ever dental visit | 3 years STANDARD_DEVIATION 2 |
| Child Behavior Checklist Total Problems | 67 T-scores STANDARD_DEVIATION 10 |
| Decayed, Missing, and Filled Permanent Teeth (DMFT) - Caries | 3.19 units on a scale STANDARD_DEVIATION 4.55 |
| Decayed, Missing, and Filled Permanent Teeth (DMFT) - Decayed Teeth | 1.19 units on a scale STANDARD_DEVIATION 2.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Past-week twice-daily toothbrushing | 2.48 number of days in past week STANDARD_DEVIATION 2.51 |
| Primary Caregiver Age | 37 years STANDARD_DEVIATION 7 |
| Primary Caregiver Education Advanced degree | 12 Participants |
| Primary Caregiver Education College degree | 7 Participants |
| Primary Caregiver Education High school graduate | 8 Participants |
| Primary Caregiver Education Less than 8th grade | 1 Participants |
| Primary Caregiver Education Some college | 32 Participants |
| Primary Caregiver Education Some high school | 3 Participants |
| Primary Caregiver Education Unknown or Not Reported | 1 Participants |
| Primary Caregiver Ethnicity Hispanic or Latino | 46 Participants |
| Primary Caregiver Ethnicity Not Hispanic or Latino | 35 Participants |
| Primary Caregiver Ethnicity Unknown or Not reported | 3 Participants |
| Primary Caregiver Living Situation Married or domestic partner | 30 Participants |
| Primary Caregiver Living Situation Single with no other adults in home | 14 Participants |
| Primary Caregiver Living Situation Single with other adults in home | 15 Participants |
| Primary Caregiver Living Situation Unknown or not reported | 0 Participants |
| Primary Caregiver Race American Indian/Alaskan Native | 1 Participants |
| Primary Caregiver Race Asian | 7 Participants |
| Primary Caregiver Race Black/African American | 3 Participants |
| Primary Caregiver Race Multi-racial | 2 Participants |
| Primary Caregiver Race Native Hawaiian/Pacific Islander | 0 Participants |
| Primary Caregiver Race Unknown/Not reported | 10 Participants |
| Primary Caregiver Race White | 71 Participants |
| Primary Caregiver Sex Female | 58 Participants |
| Primary Caregiver Sex Male | 12 Participants |
| Primary Home Language is English | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 52 Participants |
| Stanford-Binet Intelligence Scales, Fifth Edition, Abbreviated Battery Intelligence Quotient | 71.2 units on a scale STANDARD_DEVIATION 20.3 |
| Vineland Adaptive Behavior Scales, 3rd edition, Adaptive Behavior Composite Score (VABS-3 ABC) | 57.1 units on a scale STANDARD_DEVIATION 16.1 |
| Visual Plaque Index | 0.77 units on a scale STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 60 |
| other Total, other adverse events | 0 / 59 | 0 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
None listed