An observational study in Autism Spectrum Disorder, sponsored by Holland Bloorview Kids Rehabilitation Hospital. Recruiting at 1 site in Canada. Open to participants aged 0 Months to 64 Months. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Holland Bloorview Kids Rehabilitation Hospital · Observational
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Among 22 studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital — 5 open to participants now, 6 under way, none of them phase 3. Autism Spectrum Disorder · Holland Bloorview Kids Rehabilitation Hospital.
Among the 22 studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital, this one is one of 4 that started in 2022, is the only observational one, and was the 19th registered.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →5 of the 22 studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital are open now, in 1 country. Recruiting first, the newest first:
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 8–17
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 9–18
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 9–18
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 6–17
By country, each count listing its studies:
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.
This study: 0 Months to 64 Months · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 102 across 321 observational studies indexed under Autism Spectrum Disorder.
Median enrollment 60 across the 21 interventional studies, 200 across the 1 observational. Of the 14 that completed or were terminated, 3 (21%) have results posted.
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Holland Bloorview Kids Rehabilitation Hospital is the lead sponsor of 64 studies on the registry; 13 are open to participants now.
1 of the studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06081348Holland Bloorview Kids Rehabilitation HospitalSertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders | 2027-09 |
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Among the 22 studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Increasing rates of autism spectrum disorder (ASD) diagnosis have contributed to lengthy waits for expert diagnostic assessment that negatively impact ASD outcomes. Many ASD diagnostic guidelines state that an expert team is needed to make the diagnosis; although some children currently receive their diagnosis from a community-based clinician, e.g. a general paediatrician. There are very few studies of the accuracy of general pediatricians in diagnosing ASD.
The aims of this project are to:
Investigators will recruit twenty general pediatricians from across Ontario, as well as 200 of their patients (10 per general 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, cultural background, ASD severity, developmental delays, having a sibling with ASD) predict agreement in diagnosis. Exploratory analyses will be done on pediatrician factors associated with diagnostic accuracy, analyzing pediatrician years in practice, gender, rurality, extra training in child development, use of tools in the assessment, and time spent on the assessment. Children meeting the criteria for the AAPLES will be offered an additional virtual assessment where a trained clinician, blinded to the previous assessment results, will administer the AAPLES and record their diagnostic opinion. Investigators will measure agreement between this opinion and the expert team.
General pediatricians are eligible for participation if they: 1) practice in Ontario; 2) see at least one child per month with possible ASD; and 3) have not completed subspecialty training in developmental pediatrics. Consecutive children with possible ASD meeting inclusion criteria will be enrolled from each participating pediatrician (maximum of 10 per pediatrician).
Child Inclusion Criteria:
Exclusion Criteria:
For the AAPLES exploratory objective:
Inclusion Criteria:
Exclusion Criteria:
General pediatricians will assess children for possible autism spectrum disorder diagnosis as they usually would (i.e. no specific tests will be required).
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.
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.
Also known as: AAPLES
Accuracy measures
Sensitivity, specificity, positive predictive value, negative predictive value, kappa
Time frame: Within 6 weeks
Child-level predictors of accurate assessment
Investigators will conduct a logistic regression to determine the odds ratio of accurate assessment (agreement between general pediatrician and multi-disciplinary team) for each of the following factors: child age, gender, racial/ethnic background, ASD features (ADOS composite score), developmental level (Mullen Scales of Early Learning Visual Reception T-score), having an autistic sibling, pediatrician certainty (5-point Likert scale), and virtual versus in-person assessment. Regression models will be run for each of: 1) children diagnosed with ASD by the multi-disciplinary team; and 2) children not diagnosed with ASD by the multi-disciplinary team.
Time frame: Within 6 weeks
General pediatrician predictors of accurate assessment (exploratory)
Investigators will conduct a regression measuring the association between general pediatrician correct classification rate (number of children correctly diagnosed out of total number assessed) and general pediatrician gender, years in practice, practice location, extra training in child development, use of tools in the assessment, and time spent on the assessment.
Time frame: Within 6 weeks
AAPLES accuracy measures (exploratory)
Comparing the diagnostic opinion of the assessor completing the AAPLES with the multi-disciplinary team, measuring sensitivity, specificity, positive predictive value, negative predictive value, kappa
Time frame: Within 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Mar 2025, 28 months after the start.
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Holland Bloorview Kids Rehabilitation Hospital