Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Nationwide Children's Hospital | OTHER |
| California State University, Fullerton | OTHER |
| Healthy Smiles for Kids of Orange County |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR-P Dental Toolkit | Active Comparator | Families will be provided with the Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit. |
|
| Parent Training | Experimental | Families randomized to the Parent Training condition will be provided with the AIR-P Dental Toolkit and individual behavioral parent training comprised of 7 core in-person sessions, including a home visit and a dental office coach, and 4 phone booster sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Tooth Brushing at Home | Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week. | Difference in brushing frequency between Baseline and 6 months |
| Frequency of Tooth Brushing at Home | Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week. | Difference in brushing frequency between Baseline and 3 months |
| Child Oral Health According to Standardized Measures From Visual Exam | 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 | Difference in oral health between Baseline and 6 months |
| Child Oral Health According to Standardized Measures From Visual Exam | 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 | Difference in oral health between Baseline child and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Family Impact Questionnaire (FIQ) | Parenting stress associated with parenting the target autistic child. Negative Impact Composite range 0-82; higher scores index greater parenting stress. | Difference in parent-reported parenting stress at baseline and at 6 months |
| Parenting Sense of Competence Scale (PSOC) |
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robin Steinberg-Epstein, MD | University of California, Irvine | Study Chair |
| Rachel M Fenning, PhD | University of California-Irvine; California State University-Fullerton | Principal Investigator |
| Eric Butter, PhD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92705 | United States | ||
| Nationwide Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35211746 | Derived | 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. |
Not provided
Not provided
No plan to share IPD data beyond collaborating sites (MGH and NCH).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Tooth Brushing at Home | Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week. | Posted | Mean | 95% Confidence Interval | days per week | Difference in brushing frequency between Baseline and 6 months |
|
2.5 years (30 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel M. Fenning | Claremont McKenna College | (909) 607-3189 | rfenning@cmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2016 | Mar 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2020 | Mar 14, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form, IRB approved | Sep 17, 2018 | Mar 25, 2026 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Difference in child behavior between Baseline and 6 months |
| 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. 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). | Difference in child behavior between Baseline and 3 months |
| Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index. | 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. | Difference in Caries between Baseline and 6 months |
| Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index. | 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. | Difference in Caries between Baseline and 3 months |
| Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index. | 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. | Difference in decayed teeth between baseline to 6 months |
| Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index. | 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. | Difference in decayed teeth between baseline and 3 months |
| Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales) | 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. | Difference in anxiety and behavior between Baseline and 6 months |
| 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. 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. | Difference in behavioral compliance between baseline and at 6 months |
| Completion of Dental Visit Procedures According to Questionnaire | 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. | Difference between completion of dental visit procedures at baseline and at 6 months |
Parent-reported perceived parenting self-efficacy according to questionnaire, total score; range 16-96; higher scores index greater parenting self-efficacy. |
| Difference in parent-reported perceived parenting competence between baseline and 6 months |
| Columbus |
| Ohio |
| 43081 |
| United States |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stanford-Binet Intelligence Scales, Fifth Edition, Abbreviated Battery Intelligence Quotient | The reported values represent standardized scores. Child Estimated Intelligence; Mean = 100, Standard Deviation = 15; Higher scores index greater measured intelligence; instrument range 40-160 | Mean | Standard Deviation | units on a scale |
|
| Vineland Adaptive Behavior Scales, 3rd edition, Adaptive Behavior Composite Score (VABS-3 ABC) | The reported values represent standardized scores. Child adaptive behavior; mean = 100, standard deviation = 15; higher scores index greater measured adaptive behavior; instrument range generally 20-160 | Mean | Standard Deviation | units on a scale |
|
| Child Behavior Checklist Total Problems | The reported values represent T-scores. Child behavior problems; mean = 50, standard deviation = 10; higher scores index greater parent-reported child behavior problems; instrument generally ranges from 50 to >80 | Mean | Standard Deviation | T-scores |
|
| Primary Caregiver Age | Mean | Standard Deviation | years |
|
| Primary Caregiver Sex | Count of Participants | Participants |
|
| Primary Caregiver Race | Count of Participants | Participants |
|
| Primary Caregiver Ethnicity | Count of Participants | Participants |
|
| Primary Caregiver Education | Count of Participants | Participants |
|
| Primary Caregiver Living Situation | Count of Participants | Participants |
|
| Annual gross family income | Count of Participants | Participants |
|
| Primary Home Language is English | Count of Participants | Participants |
|
| Past-week twice-daily toothbrushing | Mean | Standard Deviation | number of days in past week |
|
| Behavior problem severity during home oral hygiene | 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). Raw scores ranged from 0-9, with higher scores indicating more severe problems. Items were averaged to produce a single raw score (α = 0.91). | Mean | Standard Deviation | units on a scale |
|
| Visual Plaque Index | Mean | Standard Deviation | units on a scale |
|
| Decayed, Missing, and Filled Permanent Teeth (DMFT) - Caries | dental health index that measures the total number of decayed, missing or filled permanent teeth in an individual | Mean | Standard Deviation | units on a scale |
|
| Decayed, Missing, and Filled Permanent Teeth (DMFT) - Decayed Teeth | DMFT- decay represents clinically detectable cavitated lesions. | Mean | Standard Deviation | units on a scale |
|
| Child age at first ever dental visit | Mean | Standard Deviation | years |
|
|
|
|
| Primary | Frequency of Tooth Brushing at Home | Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week. | Posted | Mean | 95% Confidence Interval | days per week | Difference in brushing frequency between Baseline and 3 months |
|
|
|
|
| Primary | Child Oral Health According to Standardized Measures From Visual Exam | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in oral health between Baseline and 6 months |
|
|
|
|
| Primary | Child Oral Health According to Standardized Measures From Visual Exam | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in oral health between Baseline child and 3 months |
|
|
|
|
| Secondary | 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. 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in child behavior between Baseline and 6 months |
|
|
|
|
| Secondary | 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. 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in child behavior between Baseline and 3 months |
|
|
|
|
| Secondary | Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in Caries between Baseline and 6 months |
|
|
|
|
| Secondary | Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in Caries between Baseline and 3 months |
|
|
|
|
| Secondary | Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in decayed teeth between baseline to 6 months |
|
|
|
|
| Secondary | Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in decayed teeth between baseline and 3 months |
|
|
|
|
| Secondary | Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales) | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in anxiety and behavior between Baseline and 6 months |
|
|
|
|
| Secondary | 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. 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in behavioral compliance between baseline and at 6 months |
|
|
|
|
| Secondary | Completion of Dental Visit Procedures According to Questionnaire | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference between completion of dental visit procedures at baseline and at 6 months |
|
|
|
|
| Other Pre-specified | Family Impact Questionnaire (FIQ) | Parenting stress associated with parenting the target autistic child. Negative Impact Composite range 0-82; higher scores index greater parenting stress. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in parent-reported parenting stress at baseline and at 6 months |
|
|
|
|
| Other Pre-specified | Parenting Sense of Competence Scale (PSOC) | Parent-reported perceived parenting self-efficacy according to questionnaire, total score; range 16-96; higher scores index greater parenting self-efficacy. | Posted | Mean | 95% Confidence Interval | score on a scale | Difference in parent-reported perceived parenting competence between baseline and 6 months |
|
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | 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. | 0 | 60 | 0 | 60 | 0 | 60 |
Not provided
Not provided