Recruiting

Observational Study

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT05699928

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

Interventions

General pediatrician autism diagnostic assessment

Multidisciplinary team diagnostic assessment

Autism Assessment for Preschoolers with Language Element Sequence

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT05699928

Start date

Nov 24, 2022

Status verified date

Feb, 2025

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

General pediatrician autism diagnostic assessment

General pediatricians will assess children for possible autism spectrum disorder diagnosis as they usually would (i.e. no specific tests will be required).

Multidisciplinary team diagnostic assessment

The multidisciplinary team will assess children for possible autism spectrum disorder diagnosis. The team consists of a developmental pediatrician, a psychologist, and a psychometrist. Administered tests include the Autism Diagnostic Interview - Revised (ADI-R; a developmental history will be substituted for children with a developmental age of <18 months), the Autism Diagnostic Observation Schedule (ADOS), and the Mullen Scales of Early Learning. When needed and available, the team will call a preschool or school teacher to gather more information about the child.

Autism Assessment for Preschoolers with Language Element Sequence

The AAPLES was developed at the Glenrose/Holland Bloorview and is designed for children who have flexible phrase speech. The assessment will be conducted virtually over Zoom Health by a trained clinician. This tool involves coaching the caregiver to interact with the child in specific ways to allow a trained professional to observe for features of ASD while watching remotely. It should take about 30-45 minutes. The individual who conducts the assessment will be blinded to the results of the other assessments. This virtual assessment will occur after the other assessments have been completed so as to not delay the child receiving a potential diagnosis.

Primary outcome measure

  • Accuracy measures [ Time Frame: Within 6 weeks ]

Central Contacts and Locations

Central contacts

Lili Senman

416-425-6220lsenman@hollandbloorview.ca

Locations

Holland Bloorview Kids Rehabilitation Hospital

Recruiting

Toronto, Ontario, Canada, M4G1R8

Contacts

Lili Senman

416-425-6220lsenman@hollandbloorview.ca

Principal Investigator:

Melanie Penner, MD MSc

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Feb 7, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2025-02-07.