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Clinical Trials in Canada / NCT05699928
Recruiting Observational

Accuracy of Community General Pediatrician Diagnosis of Autism Compared to a Multidisciplinary Team Assessment

NCT05699928 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2022-11-24
Last updated
2025-02-07

Condition(s) studied

Autism Spectrum Disorder

Investigational drug(s) / intervention(s)

General pediatrician autism diagnostic assessmentMultidisciplinary team diagnostic assessmentAutism Assessment for Preschoolers with Language Element Sequence

General pediatrician autism diagnostic assessment: General 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: The 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: The 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.

Study summary

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

Sex
ALL
Min age
0 Months
Max age
64 Months
Healthy volunteers
No
Child Inclusion Criteria: * 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) Exclusion Criteria: * Child has already received a diagnosis of ASD For the AAPLES exploratory objective: Inclusion Criteria: * Child has a developmental age of 36 months or more (determined on Mullen Scales of Early Learning) * Child has flexible phrase speech Exclusion Criteria: \- Child has previously completed a virtual ASD diagnostic assessment

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Holland Bloorview Kids Rehabilitation Hospital Toronto Ontario Recruiting

More Holland Bloorview Kids Rehabilitation Hospital trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05699928 on ClinicalTrials.gov ↗ ← All trials in Canada