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Tests an early diagnostic pathway for toddlers at high risk for autism

Tests an early diagnostic protocol in toddlers at high risk for autism spectrum disorder.

Plain-language title generated from the registry record
Registry title: Early Diagnostic Response Model (EDRM)

Key facts

Where
Atlanta, United StatesSee the site

Where in United States

  • Emory Autism CenterAtlanta, United StatesTaking people

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Trial details

Who runs it
Emory University
Trial code
NCT05419895
Record updated
10 June 2026
Original description
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.Read full original descriptionShow less

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

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.

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: 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; 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.

ClinicalTrials.gov NCT05419895