NCT05699928 Accuracy of Community General Pediatrician Diagnosis of Autism Compared to a Multidisciplinary Team Assessment
| NCT ID | NCT05699928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Holland Bloorview Kids Rehabilitation Hospital |
| Condition | Autism Spectrum Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-11-24 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-11-24 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Melanie Penner, MSc MD
PRINCIPAL INVESTIGATOR
Holland Bloorview Kids Rehabilitation Hospital
Frequently Asked Questions
Who can join the NCT05699928 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 64 Months, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05699928 currently recruiting?
Yes, NCT05699928 is actively recruiting participants. Contact the research team at lsenman@hollandbloorview.ca for enrollment information.
Where is the NCT05699928 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05699928 clinical trial?
NCT05699928 is sponsored by Holland Bloorview Kids Rehabilitation Hospital. The principal investigator is Melanie Penner, MSc MD at Holland Bloorview Kids Rehabilitation Hospital. The trial plans to enroll 200 participants.