Evaluating how well pediatricians diagnose autism compared to a specialist team
Accuracy of Community General Pediatrician Diagnosis of Autism Compared to a Multidisciplinary Team Assessment
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 0 Months to 64 Months |
| Sex | All |
| Sponsor | Holland Bloorview Kids Rehabilitation Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05699928 on ClinicalTrials.gov |
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).
Who should consider this trial
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.
Not a fit: Patients who have already received a diagnosis of ASD will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- Holland Bloorview Kids Rehabilitation Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Melanie Penner, MSc MD — Holland Bloorview Kids Rehabilitation Hospital
- Study coordinator: Lili Senman
- Email: lsenman@hollandbloorview.ca
- Phone: 416-425-6220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.