Clinical trial Recruiting at 1 site Interventional Ages 16 Months to 36 Months

A new approach to diagnosing autism in young children

Official title: Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in Early Intervention Health Districts

Run by Emory University · NCT05419895 · Data updated 2026-11-12

This study is testing a new way to diagnose autism in toddlers who are at high risk to see if it can make the process quicker and easier for families.

More Autism trials

Quick facts

Study typeInterventional
Ages16 Months to 36 Months
SexAll
Enrollment300 (estimated)
SponsorEmory University
Academic / other
Locations1 site (Atlanta, Georgia)
StatusRecruiting
StartedJune 16, 2022
Main results expectedJuly 2028
Study endsJuly 2028
Registry record updatedJune 10, 2026
Trial IDNCT05419895 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are families of children aged 16-30 months who have scored 8 or higher on the M-CHAT-R screening and are referred by a participating BCW provider.

Probably not a fit

Families whose children are older than 33 months at the time of referral or those making self-referrals will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to develop and evaluate a diagnostic protocol for toddlers at high risk for autism spectrum disorder (ASD) through the Early Diagnostic Response Model (EDRM). Families with children aged 16-30 months who score high on the M-CHAT-R screening will be referred to the Emory Autism Center for assessment. The study will utilize telehealth tools to streamline the evaluation process, addressing the current barriers of limited resources and long wait times for follow-up evaluations. The effectiveness of this model will be assessed through pre- and post-data collection and clinician satisfaction surveys.

Why it matters

Potential benefit: If successful, this approach could significantly improve access to timely autism evaluations for families in need.

How similar studies have gone: While similar telehealth approaches have been explored, this specific protocol for high-risk toddlers is novel and untested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.
* Referring BCW provider must be one of the participating BCW health districts in this pilot study.
* Parent/Guardian needs to have basic English proficiency
* Parent/Guardian needs to have internet access
* Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).
* Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.

Exclusion Criteria:

* Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.
* Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.
* Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.

Where it's running

  • Emory Autism Center
    Atlanta, Georgia, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.