Clinical trial Recruiting at 1 site Observational Ages 0 Months to 64 Months

Evaluating how well pediatricians diagnose autism compared to a specialist team

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

Run by Holland Bloorview Kids Rehabilitation Hospital · NCT05699928 · Data updated 2026-11-12

This study is testing how well regular pediatricians can diagnose autism in children compared to a team of specialists, while also trying out a new virtual tool to help with the diagnosis.

More Autism Spectrum Disorder trials

Quick facts

Study typeObservational
Ages0 Months to 64 Months
SexAll
Enrollment200 (estimated)
SponsorHolland Bloorview Kids Rehabilitation Hospital
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedNovember 24, 2022
Main results expectedMarch 31, 2025
Study endsMarch 31, 2025
Registry record updatedFebruary 7, 2025
Trial IDNCT05699928 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children under 5 years 6 months who have been referred to a participating pediatrician with concerns related to development or behavior.

Probably not a fit

Patients who have already received a diagnosis of ASD will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the accuracy of general pediatricians in diagnosing autism spectrum disorder (ASD) compared to a multidisciplinary expert team. The study will involve 20 pediatricians from Ontario, Canada, who will evaluate 200 children referred for possible ASD. The pediatricians will make their assessments without informing the families, while an expert team will conduct their evaluations independently. The study will also explore the effectiveness of a new virtual diagnostic tool, the Autism Assessment for Preschoolers with Language Element Sequence (AAPLES).

Why it matters

Potential benefit: If successful, this study could improve the accuracy of autism diagnoses in community settings, leading to earlier interventions for children.

How similar studies have gone: While there are few studies on the accuracy of general pediatricians in diagnosing ASD, this approach is relatively novel and aims to fill a significant gap in existing research.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Holland Bloorview Kids Rehabilitation Hospital
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.