Skip to content

Facilitating Autism Diagnosis in Shorter Timeframes by PCCs

Impact and Effectiveness of Training Primary Care Clinicians to Diagnose Autism in Children 18-36 Months by Primary Care Clinicians: A Multisite Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07458633
Acronym
FAST-ASD
Enrollment
300
Registered
2026-03-09
Start date
2026-03-01
Completion date
2027-10-01
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism diagnosis, ASD diagnosis

Brief 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 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.

Interventions

DIAGNOSTIC_TESTEducational training to conduct ASD diagnostic evaluations

The intervention is being trained in a 6-session curriculum designed to teach primary care clinicians to conduct autism diagnostic evaluations.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER
Boston Medical Center
CollaboratorOTHER
Baylor College of Medicine
CollaboratorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER
Children's Hospital Medical Center, Cincinnati
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

The Developmental Behavior Pediatrician (DBP). To address a secondary aim, a child who is evaluated by a primary care clinician may be seen for a confirmatory ASD evaluation. The DBP will be masked to what the Primary Care Clinician concluded at their ASD evaluation. Once the DBP completes their ASD confirmatory evaluation and concludes their own diagnosis, they will then unmask to the PCC diagnosis.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

is at the practice level: * 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

Exclusion criteria

\- Are not screening children for ASD and standard intervals of 18 and 24 months using a standard meaure.

Design outcomes

Primary

MeasureTime frameDescription
ASD Screen to Diagnostic ResolutionFrom 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.

Secondary

MeasureTime frameDescription
Diagnostic ConcordanceAt time of evaluations by the Developmental Behavioral Pediatrician within 3 months after the Primary Care Clinician has completed a diagnostic evaluationAgreement 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.
Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for AutismAfter subject enrollment is completed until month 31 of the studyDescriptive 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)

Contacts

CONTACTMeaghan Bowen
meaghan.bowen@childrens.harvard.edu617-355-5898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026