Status:
RECRUITING
Early Diagnostic Response Model (EDRM)
Lead Sponsor:
Emory University
Collaborating Sponsors:
Georgia Department of Public Health
Conditions:
Autism Spectrum Disorder
Autism
Eligibility:
All Genders
16-36 years
Phase:
NA
Brief Summary
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 Cli...
Detailed Description
The objective of this study is to develop, pilot, and evaluate a diagnostic protocol to assess high-risk toddlers for autism spectrum disorder (ASD) diagnosis of families enrolled in the Georgia Babie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05419895
Start Date
June 16 2022
End Date
July 1 2026
Last Update
May 7 2025
Active Locations (1)
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1
Emory Autism Center
Atlanta, Georgia, United States, 30322