Early Diagnostic Response Model (EDRM) for Autism, Early Infantile

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism, Early Infantile+3 More
Early Diagnostic Response Model (EDRM) - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

This trial will help to develop a diagnostic protocol for children who are at high risk for autism, in order to improve early intervention program screening.

Eligible Conditions
  • Autism, Early Infantile
  • Autism Spectrum Disorders
  • Autism Spectrum Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Autism, Early Infantile

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: Until end of the study (approximately one year)

Month 3
Parent satisfaction with access to treatment survey
Week 4
BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey
Parent satisfaction of EDRM assessment survey
Month 3
Number of participants that completed the Early Diagnostic Response Model (EDRM) study
Month 3
Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol
Number of participants with additional information collected to make a final DSM-5 conclusion
Month 3
BCW provider(s) Early Intervention Coordinator satisfaction with EDRM pilot survey
Monthly until until the end of the study (approximately one year)
Number of participants consented in the Early Diagnostic Response Model (EDRM) study
Until end of the study (approximately one year)
Response rate in the Early Diagnostic Response Model (EDRM) study
Until the end of the study (approximately one year)
Number of participants referred to the Early Diagnostic Response Model (EDRM)
Week 12
Time from referral to completion of the program

Trial Safety

Safety Progress

1 of 3

Other trials for Autism, Early Infantile

Trial Design

1 Treatment Group

Families with children with suspected diagnosis of autism
1 of 1
Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Early Diagnostic Response Model (EDRM) · No Placebo Group · N/A

Families with children with suspected diagnosis of autism
Behavioral
Experimental Group · 1 Intervention: Early Diagnostic Response Model (EDRM) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until end of the study (approximately one year)

Who is running the clinical trial?

Georgia Department of Public HealthUNKNOWN
Emory UniversityLead Sponsor
1,501 Previous Clinical Trials
2,677,456 Total Patients Enrolled
3 Trials studying Autism, Early Infantile
125 Patients Enrolled for Autism, Early Infantile
Allison Schwartz, PhDPrincipal InvestigatorEmory University

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Child must have exposure to English.\n
Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.
Referring BCW provider must be one of the three targeted BCW districts participating in this pilot study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.