NCT05419895Recruiting
Early Diagnostic Response Model (EDRM)
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
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 9 Jun 2022
- Start date
- 16 Jun 2022
- Primary completion date
- Jul 2028
- Lead sponsor
- Emory University
- Diseases
- Autism
- NCT number
- NCT05419895
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 16 Jun 2022 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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.
Other
- Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.
- 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.
Who the study is looking for
- 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.
Age in the registry: 16 months to 36 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Autism Center Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.