Autism Spectrum Disorder Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 3
Healthy Volunteers: f
View:

• 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.

Locations
United States
Georgia
Emory Autism Center
RECRUITING
Atlanta
Contact Information
Primary
Allison Schwartz, PhD
allison.schwartz@emory.edu
404.727.8350
Time Frame
Start Date: 2022-06-16
Estimated Completion Date: 2028-07
Participants
Target number of participants: 300
Treatments
Experimental: Families with children enrolled in BCW with suspected diagnosis of autism
Post-consent, families with children between 16-33 months will receive a link to complete the EAC Developmental History Survey on REDCap and a link to complete parent/caregiver questionnaires about developmental and/or adaptive information. Then, the family will be assigned to a clinician for the autism assessment and scheduled their assessment and feedback session (one week later).
Related Therapeutic Areas
Sponsors
Collaborators: Georgia Department of Public Health
Leads: Emory University

This content was sourced from clinicaltrials.gov