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Recruiting
NCT05419895
Early Diagnostic Response Model (EDRM)
Conditions: Autism Spectrum Disorder, Autism
Sex: All
Ages: 16 Months – 36 Months
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Emory University
Location: Emory Autism Center Atlanta Georgia
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 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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT05419895). StuddyBuddy aggregates publicly available trial information.