About this trial
The goals of this diagnostic study are to determine how accurate general pediatricians are in autism spectrum disorder (ASD) diagnostic assessment and which children might be best suited for this type of assessment. The investigators will also evaluate the use of a new virtual diagnostic tool, the Autism Assessment for Preschoolers with Language Element Sequence (AAPLES).
The investigators will recruit twenty general pediatricians from across Ontario, Canada, as well as 200 of their patients (maximum 10 per pediatrician) who have been referred with possible ASD. The general pediatrician will complete their assessment and decide on a diagnosis, but will not tell the family. The ASD expert team, consisting of a developmental paediatrician and a psychologist, will also perform a diagnostic assessment without knowing the general pediatrician's opinion. The team will inform the family of their diagnostic opinion. Investigators will determine the diagnostic agreement between the two assessments. They will then determine which of the child's characteristics (age, sex, racial/ethnic background, ASD features, developmental delays, having a sibling with ASD) predict agreement in diagnosis.
Some children in the study will have the option of undergoing an additional virtual autism diagnostic assessment using the AAPLES. The clinician administering the AAPLES will not know the results of the other assessments. The investigators will measure diagnostic agreement between the clinician administering the AAPLES and the expert team.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be referred to a general pediatrician participating in the study with any of the following issues: 1) Failed 18-month developmental screen (other than isolated motor delay); 2) Speech/language delay; 3) Social/emotional delay/concern; 4) Behavioral concerns, inattention, hyperactivity, or impulsivity; 5) Global developmental delay/concern; 6) A referral with a query of ASD.
Age <5 years 6 months
Resident of Ontario, Canada (support for travel is available for participants who live >100 km from Toronto)
Disqualifiers
Child has already received a diagnosis of ASD
Child has a developmental age of 36 months or more (determined on Mullen Scales of Early Learning)
Child has flexible phrase speech
Trial population
General pediatricians are eligible for participation if they: 1) practice in Ontario; 2) see at least one child per month with possible ASD; and 3) have not completed subspecialty training in developmental pediatrics. Consecutive children with possible ASD meeting inclusion criteria will be enrolled from each participating pediatrician (maximum of 10 per pediatrician).
Trial design
Other
Cross-sectional
Treatments tested in this trial
General pediatrician autism diagnostic assessment
Diagnostic testGeneral pediatricians will assess children for possible autism spectrum disorder diagnosis as they usually would (i.e. no specific tests will be required).
Multidisciplinary team diagnostic assessment
Diagnostic testThe multidisciplinary team will assess children for possible autism spectrum disorder diagnosis. The team consists of a developmental pediatrician, a psychologist, and a psychometrist. Administered tests include the Autism Diagnostic Interview - Revised (ADI-R; a developmental history will be substituted for children with a developmental age of \<18 months), the Autism Diagnostic Observation Schedule (ADOS), and the Mullen Scales of Early Learning. When needed and available, the team will call a preschool or school teacher to gather more information about the child.
Autism Assessment for Preschoolers with Language Element Sequence
Diagnostic testThe AAPLES was developed at the Glenrose/Holland Bloorview and is designed for children who have flexible phrase speech. The assessment will be conducted virtually over Zoom Health by a trained clinician. This tool involves coaching the caregiver to interact with the child in specific ways to allow a trained professional to observe for features of ASD while watching remotely. It should take about 30-45 minutes. The individual who conducts the assessment will be blinded to the results of the other assessments. This virtual assessment will occur after the other assessments have been completed so as to not delay the child receiving a potential diagnosis.
Treatment groups
Trial outcomes
Primary outcomes
Accuracy measures
Sensitivity, specificity, positive predictive value, negative predictive value, kappa
Other outcomes
Child-level predictors of accurate assessment
Investigators will conduct a logistic regression to determine the odds ratio of accurate assessment (agreement between general pediatrician and multi-disciplinary team) for each of the following factors: child age, gender, racial/ethnic background, ASD features (ADOS composite score), developmental level (Mullen Scales of Early Learning Visual Reception T-score), having an autistic sibling, pediatrician certainty (5-point Likert scale), and virtual versus in-person assessment. Regression models will be run for each of: 1) children diagnosed with ASD by the multi-disciplinary team; and 2) children not diagnosed with ASD by the multi-disciplinary team.
General pediatrician predictors of accurate assessment (exploratory)
Investigators will conduct a regression measuring the association between general pediatrician correct classification rate (number of children correctly diagnosed out of total number assessed) and general pediatrician gender, years in practice, practice location, extra training in child development, use of tools in the assessment, and time spent on the assessment.
AAPLES accuracy measures (exploratory)
Comparing the diagnostic opinion of the assessor completing the AAPLES with the multi-disciplinary team, measuring sensitivity, specificity, positive predictive value, negative predictive value, kappa
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