Facilitating Autism Diagnosis in Shorter Timeframes by PCCs

NCT07458633 | Not Yet Recruiting

• 1 other identifier: IRB-P00052418
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Autism Spectrum Disorder

Keywords

Autism diagnosis; ASD diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  After subject enrollment is completed until month 31 of the study

• Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism

  After subject enrollment is completed until month 31 of the study

• Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism

  After subject recruitment is complete until month 31 of the study

• Barriers and Facilitators of Implementing Primary Care Diagnostic Evaluations for Autism

  After subject enrollment is completed until month 31 of the study

Study Arms (2)

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.

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.

Interventions

Educational training to conduct ASD diagnostic evaluations DIAGNOSTIC_TEST

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

Immediate training in Autism Diagnostic Evaluations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Boston Medical Center: collaborator
• Baylor College of Medicine: collaborator
• Children's Hospital of Philadelphia: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Meaghan Bowen

CONTACT

617-355-5898; meaghan.bowen@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03