NCT05699928Recruiting
Accuracy of Community General Pediatrician Diagnosis of Autism Compared to a Multidisciplinary Team Assessment
Source: ClinicalTrials.gov · Last updated 7 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 4 Jan 2023
- Start date
- 24 Nov 2022
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Diseases
- Autism
- NCT number
- NCT05699928
What you commit to
- Study type: Observational
- Planned participants: 200
- From 24 Nov 2022 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Child has already received a diagnosis of ASD
- For the AAPLES exploratory objective:
- \- Child has previously completed a virtual ASD diagnostic assessment
Who the study is looking for
- Child has a developmental age of 36 months or more (determined on Mullen Scales of Early Learning)
- Child has flexible phrase speech
Criteria the registry did not label
- 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)
Age in the registry: 0 months to 64 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Holland Bloorview Kids Rehabilitation Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.