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EDRM for Autism

N/A
Recruiting
Led By Allison Schwartz, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until the end of the study (approximately one year)
Awards & highlights

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.

Who is the study for?
This trial is for families with children aged 16-30 months at risk for autism, referred by specific BCW districts. Participants need internet access, exposure to English, and basic English skills. Children must score ≥8 on the MCHAT-R and be referred by 33 months of age.Check my eligibility
What is being tested?
The EDRM protocol is being tested to see if it's effective in diagnosing autism early in kids identified as high-risk in a public health service program. The study will collect data before and after implementing EDRM to assess its success.See study design
What are the potential side effects?
Since this trial involves an evaluation of a diagnostic model rather than a medical intervention, there are no direct side effects like those associated with medications or treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants consented in the Early Diagnostic Response Model (EDRM) study
Number of participants referred to the Early Diagnostic Response Model (EDRM)
Number of participants that completed the Early Diagnostic Response Model (EDRM) study
+2 more
Secondary outcome measures
BCW provider(s) Early Intervention Coordinator satisfaction with EDRM pilot survey
BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey
Number of families screened high risk for ASD and referred for an evaluation
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Families with children enrolled in BCW with suspected diagnosis of autismExperimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,645 Previous Clinical Trials
2,564,250 Total Patients Enrolled
23 Trials studying Autism Spectrum Disorder
21,287 Patients Enrolled for Autism Spectrum Disorder
Georgia Department of Public HealthUNKNOWN
Allison Schwartz, PhDPrincipal InvestigatorEmory University

Media Library

Early Diagnostic Response Model (EDRM) Clinical Trial Eligibility Overview. Trial Name: NCT05419895 — N/A
Autism Spectrum Disorder Research Study Groups: Families with children enrolled in BCW with suspected diagnosis of autism
Autism Spectrum Disorder Clinical Trial 2023: Early Diagnostic Response Model (EDRM) Highlights & Side Effects. Trial Name: NCT05419895 — N/A
Early Diagnostic Response Model (EDRM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05419895 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available to those interested in participating in this clinical trial?

"According to data from clinicaltrials.gov, this experiment is currently in the process of recruitment. The initial posting was made on 16th June 2022 and last revised 17th June 2022."

Answered by AI

Can elderly individuals aged 60 or older join this research initiative?

"According to the prerequisites for participation, infants and toddlers aged 16 months to 36 months are eligible."

Answered by AI

What types of individuals are ideal candidates for this experiment?

"This clinical trial will be accepting one-hundred autistic children between the ages of 16 to 36 months old. Most significantly, applicants must meet the following criteria: A score ≥ 8 on MCHAT-R assessments; a parent or guardian with basic English proficiency and internet access; exposure to English at home or in out-of-home care (e.g., childcare setting); documentation of an MCHAT-R high risk failed score (≥ 8) in their referral; and lastly, referring BCW provider from any of the three targeted districts participating in this pilot study."

Answered by AI

How many participants are involved in this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that enrollment for this trial, which was initially published on June 16th 2022 is still in progress. This study calls for 100 participants at a single medical site."

Answered by AI

What are the projected results from this research endeavor?

"The primary aim of this trial, to be monitored over the course of one year, is assessing how many participants successfully complete the Early Diagnostic Response Model (EDRM) study. Secondary objectives include evaluating parent satisfaction with EDRM assessment through a Likert-scale survey ranging from 1-5 and tracking high-risk referral assessments completed via telehealth protocol, as well as measuring BCW provider Early Intervention Coordinator satisfaction with EDRM pilot surveys every three months."

Answered by AI
~103 spots leftby Jun 2025