Autism Spectrum DisorderFAST-ASDNCT07458633
Facilitating Autism Diagnosis in Shorter Timeframes by PCCs
A study testing Educational training to conduct ASD diagnostic evaluations in people with Autism Spectrum Disorder, run by Boston Children's Hospital.
Trial summary
This study is looking at time to diagnostic resolution for children ages 18-36 months with concern of ASD. The main purpose of this research study is to see if the time between when a child aged 18-36 months fails an autism screen or a clinician raises concern and is evaluated is shorter in the primary care practices… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Educational training to conduct ASD diagnostic evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Oct 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are physicians or nurse practitioners.
- -- Currently screen children for ASD at 18 and 24 months using a standard measure
- Willing to have practice randomized and willing to defer PCC training if they are randomized to the control group.
- Will obtain permission from parents of children 18-36 months with a positive autism screen or clinician concern for research staff to contact them
- Will attend all training courses, complete all requirements of training, and complete questionnaires that are designed to assess the educational intervention.
- Will keep a record of all diagnostic evaluations they complete over the study period including those children not referred for diagnostic concordance evaluation if they are randomized to the intervention group
Who cannot join
- Are not screening children for ASD and standard intervals of 18 and 24 months using a standard meaure.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact and Effectiveness of Training Primary Care Clinicians to Diagnose Autism in Children 18-36 Months by Primary Care Clinicians: A Multisite Study
This study is looking at time to diagnostic resolution for children ages 18-36 months with concern of ASD. The main purpose of this research study is to see if the time between when a child aged 18-36 months fails an autism screen or a clinician raises concern and is evaluated is shorter in the primary care practices where the clinicians have been trained to conduct diagnostic evaluations. The training includes use of the Childhood Autism Rating Scale-2, which is validated for use in children 2 and older. The investigators also want to learn more about whether primary care clinicians can accurately evaluate and diagnose young children ages 18-36 months of age with autism spectrum disorder (ASD).
Read the detailed description
The investigators will conduct a multisite hybrid 1 effectiveness-implementation cluster randomized clinical trial to determine if training Primary Care Clinicians (PCCs) to diagnose autism spectrum disorder (ASD) in young children is an effective strategy for decreasing time from a result indicative of increased likelihood of autism, as determined from a visit in primary care, to diagnostic resolution defined as either making or excluding a diagnosis of autism. The investigators will also assess diagnostic concordance between PCCs and autism experts and facilitators and barriers to implementation of this model. Through pediatric clinics, the investigators will be training primary care clinicians (PCCs) to diagnose ASD as part of an established training program, and will assess their diagnostic accuracy by prospectively enrolling patients at the time of their referral for a confirmatory evaluation by a DBP and comparing their CARS scores and certainty ratings. PCCs will be surveyed about their experiences and feedback about training.
There are 3 cohorts of participants in this study:
Group 1 are primary care clinicians, and will be consented into the study and asked to perform the following activities: complete ASD diagnostic training, either in the immediate intervention or delayed intervention group; continue conducting ASD screening per standard of care; refer patients requiring diagnostic confirmation to one of the study sites, including evaluation on diagnostic accuracy.
Group 2 are staff at a primary care practice where one or more clinician are taking part in the training. They will be given the option to participate in surveys and/or focus groups asking about the impact of this autism assessment training on their practices and workflows.
Group 3 are the parents/legally authorized representatives of patients (age 18-36 months) with a flagged result on an autism screener, distributed per standard of care by their pediatrician/PCC's office. They will be contacted by study staff and verbally consented into the study. They will be asked to complete monthly telephone surveys, for up to 8 months. A subset (referred to as Group 3B) will be referred by their PCCs for confirmatory evaluation at one of the clinical study sites. They will be asked to provide written consent for sharing of their evaluation and relevant information from their medical record.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Educational training to conduct ASD diagnostic evaluations
- Keywords
- Autism diagnosis, ASD diagnosis
- 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.
Educational training to conduct ASD diagnostic evaluationsDiagnostic test
The intervention is being trained in a 6-session curriculum designed to teach primary care clinicians to conduct autism diagnostic evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Immediate training in Autism Diagnostic Evaluations | Experimental | Practices in this group will include Primary Care Clinicians who receive immediate training in a 6-session educational program designed to teach them to diagnose autism in children 18-36 months who are at high risk for ASD. Receives: Diagnostic Test: Educational training to conduct ASD diagnostic evaluations |
| Deferred Training; control Group | No intervention | Practices in this group will include Primary Care Clinicians who will deferred training receive similar training to the PCCs in the intervention group after data collection is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASD Screen to Diagnostic Resolution
Mean time to diagnostic resolution between intervention and control sites. Time to diagnostic resolution is defined as the time from the first positive screen for autism in the practice or clinician concern raised until an evaluation is completed in which the child is either diagnosed with autism or the evaluation concludes that the child does not have autism.
Measured: From time of study enrollment after a positive ASD screen or clinician concern to diagnostic resolution or 8 months have elapsed.
Secondary outcomes (5)
Diagnostic Concordance
Agreement between Primary Care Clinician evaluation versus Developmental Behavioral Pediatrician evaluation (diagnostic concordance) on the CARS-2 (Childhood Autism Rating Scale- 2nd Edition, Standard Version), a 15 item well recognized measure used to help identify and assess the severity of autism spectrum disorder (ASD) in children. Clinician Confidence in Diagnostic Assessment will be rated on a 5-point Likert scale from 1= Not at all sure of diagnostic conclusion to 5=Highly certain of diagnostic conclusion.
Measured: At time of evaluations by the Developmental Behavioral Pediatrician within 3 months after the Primary Care Clinician has completed a diagnostic evaluation
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism
Descriptive statistical (means, SD or median, IQR for non-parametric data) summaries of responses to the Acceptability of Intervention Measure ( 4 item measure with scale of 1-5 with higher scores indicating endorsement of acceptability)
Measured: After subject enrollment is completed until month 31 of the study
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism
Descriptive statistical (means, SD or median, IQR for non-parametric data) summaries of responses to the Intervention Appropriateness Measure ( 4 item measure with scale of 1-5 with higher scores indicating endorsement of intervention appropriateness)
Measured: After subject enrollment is completed until month 31 of the study
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism
Descriptive statistical (means, SD or median, IQR for non-parametric data) summaries of responses to the Feasibility of Intervention Measure (4 item measure with scale of 1-5, with higher scores indicating endorsement of feasibility)
Measured: After subject recruitment is complete until month 31 of the study
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism
Qualitative analysis of interviews of selected key informants including of PCCs, nurses, practice administrators and parents of children who were evaluated by PCCs in the primary care practice.
Measured: After subject enrollment is completed until month 31 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (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.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two arms to the study. Pediatric practices will be randomized and the primary care clinicians in the intervention group will be trained immediately to complete autism diagnostic evaluations. The non-intervention, control group, will have deferred training that is delivered after the period of data collection.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, Baylor College of Medicine, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Carol Weitzman, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458633
- Sponsor's protocol ID
- IRB-P00052418
- Acronym
- FAST-ASD
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be discussed with Autism Research Consortium Steering Committee
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Effectiveness of Training Primary Care Clinicians to Diagnose Autism in Children 18-36 Months by Primary Care Clinicians: A Multisite Study
- ClinicalTrials.gov ID
- NCT07458633
- Acronym / sponsor ID
- FAST-ASD / IRB-P00052418
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism diagnosis, ASD diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Boston Medical Center, Baylor College of Medicine, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 9 Mar 2026 (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.
This study is looking at time to diagnostic resolution for children ages 18-36 months with concern of ASD. The main purpose of this research study is to see if the time between when a child aged 18-36 months fails an autism screen or a clinician raises concern and is evaluated is shorter in the primary care practices where the clinicians have been trained to conduct diagnostic evaluations. The training includes use of the Childhood Autism Rating Scale-2, which is validated for use in children 2 and older. The investigators also want to learn more about whether primary care clinicians can accurately evaluate and diagnose young children ages 18-36 months of age with autism spectrum disorder (ASD).
Detailed description
The investigators will conduct a multisite hybrid 1 effectiveness-implementation cluster randomized clinical trial to determine if training Primary Care Clinicians (PCCs) to diagnose autism spectrum disorder (ASD) in young children is an effective strategy for decreasing time from a result indicative of increased likelihood of autism, as determined from a visit in primary care, to diagnostic resolution defined as either making or excluding a diagnosis of autism. The investigators will also assess diagnostic concordance between PCCs and autism experts and facilitators and barriers to implementation of this model. Through pediatric clinics, the investigators will be training primary care clinicians (PCCs) to diagnose ASD as part of an established training program, and will assess their diagnostic accuracy by prospectively enrolling patients at the time of their referral for a confirmatory evaluation by a DBP and comparing their CARS scores and certainty ratings. PCCs will be surveyed about their experiences and feedback about training.
There are 3 cohorts of participants in this study:
Group 1 are primary care clinicians, and will be consented into the study and asked to perform the following activities: complete ASD diagnostic training, either in the immediate intervention or delayed intervention group; continue conducting ASD screening per standard of care; refer patients requiring diagnostic confirmation to one of the study sites, including evaluation on diagnostic accuracy.
Group 2 are staff at a primary care practice where one or more clinician are taking part in the training. They will be given the option to participate in surveys and/or focus groups asking about the impact of this autism assessment training on their practices and workflows.
Group 3 are the parents/legally authorized representatives of patients (age 18-36 months) with a flagged result on an autism screener, distributed per standard of care by their pediatrician/PCC's office. They will be contacted by study staff and verbally consented into the study. They will be asked to complete monthly telephone surveys, for up to 8 months. A subset (referred to as Group 3B) will be referred by their PCCs for confirmatory evaluation at one of the clinical study sites. They will be asked to provide written consent for sharing of their evaluation and relevant information from their medical record.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two arms to the study. Pediatric practices will be randomized and the primary care clinicians in the intervention group will be trained immediately to complete autism diagnostic evaluations. The non-intervention, control group, will have deferred training that is delivered after the period of data collection.
| Arm | Type | Receives |
|---|---|---|
| Immediate training in Autism Diagnostic Evaluations | Experimental | Diagnostic Test: Educational training to conduct ASD diagnostic evaluationsPractices in this group will include Primary Care Clinicians who receive immediate training in a 6-session educational program designed to teach them to diagnose autism in children 18-36 months who are at high risk for ASD. |
| Deferred Training; control Group | No intervention | –Practices in this group will include Primary Care Clinicians who will deferred training receive similar training to the PCCs in the intervention group after data collection is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are physicians or nurse practitioners.
- -- Currently screen children for ASD at 18 and 24 months using a standard measure
- Willing to have practice randomized and willing to defer PCC training if they are randomized to the control group.
Key exclusion criteria (1 listed)
- Are not screening children for ASD and standard intervals of 18 and 24 months using a standard meaure.
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 |
|---|---|---|
| Educational training to conduct ASD diagnostic evaluationsThe intervention is being trained in a 6-session curriculum designed to teach primary care clinicians to conduct autism diagnostic evaluations. | Diagnostic test | Immediate training in Autism Diagnostic Evaluations |
Primary outcome
ASD Screen to Diagnostic Resolution
Time frame: From time of study enrollment after a positive ASD screen or clinician concern to diagnostic resolution or 8 months have elapsed.
Mean time to diagnostic resolution between intervention and control sites. Time to diagnostic resolution is defined as the time from the first positive screen for autism in the practice or clinician concern raised until an evaluation is completed in which the child is either diagnosed with autism or the evaluation concludes that the child does not have autism.
5 secondary outcomes
Diagnostic Concordance
Time frame: At time of evaluations by the Developmental Behavioral Pediatrician within 3 months after the Primary Care Clinician has completed a diagnostic evaluation
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism
Time frame: After subject enrollment is completed until month 31 of the study
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism
Time frame: After subject enrollment is completed until month 31 of the study
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism
Time frame: After subject recruitment is complete until month 31 of the study
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism
Time frame: After subject enrollment is completed until month 31 of the study
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 9 Mar 2026.
- Individual participant dataSharing planned: Undecided. This will be discussed with Autism Research Consortium Steering Committee
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Educational training to conduct ASD diagnostic evaluations in people with Autism Spectrum Disorder, run by Boston Children's Hospital.
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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Meaghan Bowen (617-355-5898, meaghan.bowen@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASD Screen to Diagnostic Resolution (time frame: From time of study enrollment after a positive ASD screen or clinician concern to diagnostic resolution or 8 months have elapsed.). 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 9 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.