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Recruiting NCT05699928

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

Conditions: Autism Spectrum Disorder

Sex: All
Ages: 0 Months – 64 Months
Enrollment: 200
Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Location: Canada

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 monthsResident 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 ASDFor 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 speechExclusion Criteria:- Child has previously completed a virtual ASD diagnostic assessment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05699928). StuddyBuddy aggregates publicly available trial information.