A new approach to diagnosing autism in young children
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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 16 Months to 36 Months |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05419895 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While similar telehealth approaches have been explored, this specific protocol for high-risk toddlers is novel and untested.
Eligibility criteria
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 this trial is running
Atlanta, Georgia
- Emory Autism Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Allison Schwartz, PhD — Emory University
- Study coordinator: Allison Schwartz, PhD
- Email: allison.schwartz@emory.edu
- Phone: 404.727.8350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.