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Early Diagnostic Response Model (EDRM)

Early Diagnostic Response Model (EDRM)

Recruiting
16-36 years
All
Phase N/A

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Overview

Three districts of Babies Can't Wait (BCW) 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.

Description

The objective of this study is to develop, pilot, and evaluate a diagnostic protocol to assess high-risk infants and children for autism diagnosis for families with young children enrolled in the Georgia BCW early intervention program. The Early Diagnostic Response Model (EDRM) project will be addressing children who are identified at high risk for autism according to the BCW screening protocol, which is the M-CHAT-R. Currently, many children who are screening high-risk for autism in BCW districts are unable to access follow-up evaluations due to limited community resources and long wait times. It is hypothesized that the EDRM will be successful in increasing the number of BCW families that access an autism assessment using telehealth tools and testing protocols and that the families and clinicians involved will be satisfied with the streamlined process. The clinicians' conclusions from the EDRM assessment will be based on the Diagnostic and Statistical Manual, 5th edition, Text revision (DSM-5-TR; 2022) and are hypothesized to be able to provide families with the same access to services as an in-person assessment.

A secondary objective is to investigate how many high-risk referral assessments can be completed entirely via streamlined telehealth protocol and how many needed additional information collected to make a final DSM-5-TR conclusion. Results of this study will provide meaningful data on the validity of partnering with early intervention (EI) and using telehealth technology for families to receive a diagnosis of autism, and to diagnose and start EI services specifically aimed at autism symptoms when needed.

Eligibility

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 three targeted BCW districts participating 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 high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.

Study details
    Autism Spectrum Disorder
    Autism

NCT05419895

Emory University

27 January 2024

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