Trial Outcomes & Findings for Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder (NCT NCT03003221)
NCT ID: NCT03003221
Last Updated: 2026-06-15
Results Overview
Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
Difference in brushing frequency between Baseline and 6 months
Results posted on
2026-06-15
Participant Flow
Participant milestones
| Measure |
AIR-P Dental Toolkit
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
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.
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
|
Overall Study
3-Month Follow-Up
|
56
|
55
|
|
Overall Study
COMPLETED
|
55
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
| Measure |
AIR-P Dental Toolkit
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
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.
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.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
Baseline Characteristics
Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder
Baseline characteristics by cohort
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.4 years
STANDARD_DEVIATION 2.7 • n=20 Participants
|
7.3 years
STANDARD_DEVIATION 2.6 • n=20 Participants
|
7.4 years
STANDARD_DEVIATION 2.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=20 Participants
|
49 Participants
n=20 Participants
|
101 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
65 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
69 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=20 Participants
|
60 participants
n=20 Participants
|
119 participants
n=40 Participants
|
|
Stanford-Binet Intelligence Scales, Fifth Edition, Abbreviated Battery Intelligence Quotient
|
71.2 units on a scale
STANDARD_DEVIATION 20.3 • n=20 Participants
|
66.2 units on a scale
STANDARD_DEVIATION 19.5 • n=20 Participants
|
68.7 units on a scale
STANDARD_DEVIATION 20.0 • n=40 Participants
|
|
Vineland Adaptive Behavior Scales, 3rd edition, Adaptive Behavior Composite Score (VABS-3 ABC)
|
57.8 units on a scale
STANDARD_DEVIATION 19.1 • n=20 Participants
|
57.1 units on a scale
STANDARD_DEVIATION 16.1 • n=20 Participants
|
57.5 units on a scale
STANDARD_DEVIATION 17.6 • n=40 Participants
|
|
Child Behavior Checklist Total Problems
|
67 T-scores
STANDARD_DEVIATION 10 • n=20 Participants
|
65 T-scores
STANDARD_DEVIATION 9 • n=20 Participants
|
66 T-scores
STANDARD_DEVIATION 10 • n=40 Participants
|
|
Primary Caregiver Age
|
37 years
STANDARD_DEVIATION 9 • n=20 Participants
|
37 years
STANDARD_DEVIATION 7 • n=20 Participants
|
37 years
STANDARD_DEVIATION 8 • n=40 Participants
|
|
Primary Caregiver Sex
Female
|
48 Participants
n=20 Participants
|
58 Participants
n=20 Participants
|
106 Participants
n=40 Participants
|
|
Primary Caregiver Sex
Male
|
10 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Primary Caregiver Race
White
|
34 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
71 Participants
n=40 Participants
|
|
Primary Caregiver Race
Asian
|
6 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Primary Caregiver Race
Black/African American
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Primary Caregiver Race
Native Hawaiian/Pacific Islander
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Primary Caregiver Race
American Indian/Alaskan Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Primary Caregiver Race
Multi-racial
|
5 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Primary Caregiver Race
Unknown/Not reported
|
9 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Primary Caregiver Ethnicity
Hispanic or Latino
|
22 Participants
n=20 Participants
|
24 Participants
n=20 Participants
|
46 Participants
n=40 Participants
|
|
Primary Caregiver Ethnicity
Not Hispanic or Latino
|
34 Participants
n=20 Participants
|
35 Participants
n=20 Participants
|
69 Participants
n=40 Participants
|
|
Primary Caregiver Ethnicity
Unknown or Not reported
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Primary Caregiver Education
Less than 8th grade
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Primary Caregiver Education
Some high school
|
3 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Primary Caregiver Education
High school graduate
|
12 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Primary Caregiver Education
Some college
|
24 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
56 Participants
n=40 Participants
|
|
Primary Caregiver Education
College degree
|
8 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Primary Caregiver Education
Advanced degree
|
7 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Primary Caregiver Education
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Primary Caregiver Living Situation
Married or domestic partner
|
30 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Primary Caregiver Living Situation
Single with other adults in home
|
15 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
Primary Caregiver Living Situation
Single with no other adults in home
|
12 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Primary Caregiver Living Situation
Unknown or not reported
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Annual gross family income
<$15,000
|
8 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Annual gross family income
$15,000-$24,999
|
13 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Annual gross family income
$25,000-$34,999
|
14 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Annual gross family income
$35,000-$49,999
|
7 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Annual gross family income
$50,000-$74,999
|
6 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Annual gross family income
≥$75,000
|
6 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Annual gross family income
Unknown or not reported
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Primary Home Language is English
|
47 Participants
n=20 Participants
|
50 Participants
n=20 Participants
|
97 Participants
n=40 Participants
|
|
Past-week twice-daily toothbrushing
|
3.74 number of days in past week
STANDARD_DEVIATION 2.90 • n=20 Participants
|
2.48 number of days in past week
STANDARD_DEVIATION 2.51 • n=20 Participants
|
3.10 number of days in past week
STANDARD_DEVIATION 2.77 • n=40 Participants
|
|
Behavior problem severity during home oral hygiene
|
2.78 units on a scale
STANDARD_DEVIATION 2.33 • n=20 Participants
|
2.92 units on a scale
STANDARD_DEVIATION 2.39 • n=20 Participants
|
2.85 units on a scale
STANDARD_DEVIATION 2.35 • n=40 Participants
|
|
Visual Plaque Index
|
0.77 units on a scale
STANDARD_DEVIATION 0.50 • n=20 Participants
|
0.95 units on a scale
STANDARD_DEVIATION 0.68 • n=20 Participants
|
0.86 units on a scale
STANDARD_DEVIATION 0.60 • n=40 Participants
|
|
Decayed, Missing, and Filled Permanent Teeth (DMFT) - Caries
|
2.72 units on a scale
STANDARD_DEVIATION 3.21 • n=20 Participants
|
3.19 units on a scale
STANDARD_DEVIATION 4.55 • n=20 Participants
|
2.96 units on a scale
STANDARD_DEVIATION 3.94 • n=40 Participants
|
|
Decayed, Missing, and Filled Permanent Teeth (DMFT) - Decayed Teeth
|
0.67 units on a scale
STANDARD_DEVIATION 1.39 • n=20 Participants
|
1.19 units on a scale
STANDARD_DEVIATION 2.12 • n=20 Participants
|
0.93 units on a scale
STANDARD_DEVIATION 1.81 • n=40 Participants
|
|
Child age at first ever dental visit
|
3 years
STANDARD_DEVIATION 2 • n=20 Participants
|
3 years
STANDARD_DEVIATION 2 • n=20 Participants
|
3 years
STANDARD_DEVIATION 2 • n=40 Participants
|
PRIMARY outcome
Timeframe: Difference in brushing frequency between Baseline and 6 monthsParent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Frequency of Tooth Brushing at Home
|
4.3 days per week
Interval 3.5 to 5.1
|
5.5 days per week
Interval 4.8 to 6.0
|
PRIMARY outcome
Timeframe: Difference in brushing frequency between Baseline and 3 monthsParent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Frequency of Tooth Brushing at Home
|
3.9 days per week
Interval 3.1 to 4.7
|
5.4 days per week
Interval 4.8 to 5.9
|
PRIMARY outcome
Timeframe: Difference in oral health between Baseline and 6 monthsDentist 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
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Child Oral Health According to Standardized Measures From Visual Exam
|
0.80 score on a scale
Interval 0.67 to 0.92
|
0.75 score on a scale
Interval 0.62 to 0.88
|
PRIMARY outcome
Timeframe: Difference in oral health between Baseline child and 3 monthsDentist 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
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Child Oral Health According to Standardized Measures From Visual Exam
|
0.87 score on a scale
Interval 0.74 to 1.0
|
0.68 score on a scale
Interval 0.55 to 0.81
|
SECONDARY outcome
Timeframe: Difference in child behavior between Baseline and 6 monthsParent-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).
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Child Behavior During Tooth Brushing at Home According to Questionnaire
|
2.14 score on a scale
Interval 1.64 to 2.64
|
1.37 score on a scale
Interval 0.86 to 1.88
|
SECONDARY outcome
Timeframe: Difference in child behavior between Baseline and 3 monthsParent-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).
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Child Behavior During Tooth Brushing at Home According to Questionnaire
|
2.62 score on a scale
Interval 2.12 to 3.11
|
1.71 score on a scale
Interval 1.21 to 2.22
|
SECONDARY outcome
Timeframe: Difference in Caries between Baseline and 6 monthsDentists 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.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
|
1.09 score on a scale
Interval 0.41 to 2.91
|
0.93 score on a scale
Interval 0.35 to 2.5
|
SECONDARY outcome
Timeframe: Difference in Caries between Baseline and 3 monthsDentists 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.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
|
1.14 score on a scale
Interval 0.43 to 3.06
|
0.84 score on a scale
Interval 0.31 to 2.26
|
SECONDARY outcome
Timeframe: Difference in decayed teeth between baseline to 6 monthsDentists 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.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
|
0.51 score on a scale
Interval 0.31 to 0.83
|
0.34 score on a scale
Interval 0.2 to 0.55
|
SECONDARY outcome
Timeframe: Difference in decayed teeth between baseline and 3 monthsDentists 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.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
|
0.47 score on a scale
Interval 0.29 to 0.77
|
0.34 score on a scale
Interval 0.21 to 0.55
|
SECONDARY outcome
Timeframe: Difference in anxiety and behavior between Baseline and 6 monthsObserved 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.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales)
|
2.31 score on a scale
Interval 1.82 to 2.8
|
2.36 score on a scale
Interval 1.86 to 2.85
|
SECONDARY outcome
Timeframe: Difference in behavioral compliance between baseline and at 6 monthsDentist-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.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Dentist-reported Child Behavioral Compliance During Dental Office Visit as Indexed by Questionnaire
|
1.94 score on a scale
Interval 0.71 to 3.17
|
1.94 score on a scale
Interval 0.71 to 3.17
|
SECONDARY outcome
Timeframe: Difference between completion of dental visit procedures at baseline and at 6 monthsDentist-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.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Completion of Dental Visit Procedures According to Questionnaire
|
2.70 score on a scale
Interval 1.28 to 4.12
|
3.30 score on a scale
Interval 1.88 to 4.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Difference in parent-reported parenting stress at baseline and at 6 monthsParenting stress associated with parenting the target autistic child. Negative Impact Composite range 0-82; higher scores index greater parenting stress.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Family Impact Questionnaire (FIQ)
|
25.96 score on a scale
Interval 23.14 to 28.77
|
25.49 score on a scale
Interval 22.63 to 28.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Difference in parent-reported perceived parenting competence between baseline and 6 monthsParent-reported perceived parenting self-efficacy according to questionnaire, total score; range 16-96; higher scores index greater parenting self-efficacy.
Outcome measures
| Measure |
AIR-P Dental Toolkit
n=59 Participants
Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
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.
|
Parent Training
n=60 Participants
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.
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.
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.
|
|---|---|---|
|
Parenting Sense of Competence Scale (PSOC)
|
69.20 score on a scale
Interval 66.51 to 71.89
|
68.35 score on a scale
Interval 65.61 to 71.08
|
Adverse Events
AIR-P Dental Toolkit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parent Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place