Autism Spectrum DisorderNCT05699928
Accuracy of Community General Pediatrician Diagnosis of Autism Compared to a Multidisciplinary Team Assessment
An observational study of Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 64 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- General pediatrician autism diagnostic assessment, Multidisciplinary team diagnostic assessment and Autism Assessment for Preschoolers with Language Element Sequence
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 64 months
- All sexes
- No healthy volunteers
- Child
Study population: 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).
Who may be able to join
- Child has a developmental age of 36 months or more (determined on Mullen Scales of Early Learning)
- Child has flexible phrase speech
Who cannot join
- Child has already received a diagnosis of ASD
- For the AAPLES exploratory objective:
- Child has previously completed a virtual ASD diagnostic assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G1R8
Lili Senman, 416-425-6220 ext. 6517, lsenman@hollandbloorview.ca
Melanie Penner, MD MSc
About this study
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.
Read the detailed description
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:
- determine accuracy of general pediatrician ASD diagnosis compared to an expert team assessment;
- to determine child features associated with accurate diagnosis by general pediatricians (possible features include: child's age; gender; cultural background; ASD features; developmental delays; and having a sibling with ASD; pediatrician certainty; virtual versus in person assessment);
- to identify general pediatrician factors associated with accurate diagnosis (possible features include pediatrician years in practice, gender, rurality, extra training in child development, use of tools in the assessment, time spent on the assessment);
- to determine the concordance between an assessment with the AAPLES virtual tool and the expert team assessment.
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- General pediatrician autism diagnostic assessment, Multidisciplinary team diagnostic assessment, Autism Assessment for Preschoolers with Language Element Sequence
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General pediatrician autism diagnostic assessmentDiagnostic test
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 assessmentDiagnostic test
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 SequenceDiagnostic test
Also called AAPLES
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy measures
Sensitivity, specificity, positive predictive value, negative predictive value, kappa
Measured: Within 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start24 Nov 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Penner, MSc MD, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699928
- Sponsor's protocol ID
- 218
- Status last verified
- Feb 2025
- First submitted
- 4 Jan 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Community General Pediatrician Diagnosis of Autism Compared to a Multidisciplinary Team Assessment
- ClinicalTrials.gov ID
- NCT05699928
- Acronym / sponsor ID
- 218
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- determine accuracy of general pediatrician ASD diagnosis compared to an expert team assessment;
- to determine child features associated with accurate diagnosis by general pediatricians (possible features include: child's age; gender; cultural background; ASD features; developmental delays; and having a sibling with ASD; pediatrician certainty; virtual versus in person assessment);
- to identify general pediatrician factors associated with accurate diagnosis (possible features include pediatrician years in practice, gender, rurality, extra training in child development, use of tools in the assessment, time spent on the assessment);
- to determine the concordance between an assessment with the AAPLES virtual tool and the expert team assessment.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 64 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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).
Key inclusion criteria (2 listed)
- Child has a developmental age of 36 months or more (determined on Mullen Scales of Early Learning)
- Child has flexible phrase speech
Key exclusion criteria (3 listed)
- Child has already received a diagnosis of ASD
- Child has previously completed a virtual ASD diagnostic assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General pediatrician autism diagnostic assessmentGeneral pediatricians will assess children for possible autism spectrum disorder diagnosis as they usually would (i.e. no specific tests will be required). | Diagnostic test | – |
| Multidisciplinary team diagnostic assessmentThe 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. | Diagnostic test | – |
| Autism Assessment for Preschoolers with Language Element SequenceAlso: AAPLESThe 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. | Diagnostic test | – |
Primary outcome
Accuracy measures
Time frame: Within 6 weeks
Sensitivity, specificity, positive predictive value, negative predictive value, kappa
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Penner, MSc MD principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lili Senman (416-425-6220 ext. 6517, lsenman@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy measures (time frame: Within 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.