Early Diagnostic Response Model (EDRM)

NCT05419895 | Recruiting

• 1 other identifier: STUDY00003763
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder; Autism

Keywords

Autism; Early Intervention; Telehealth; Assessment

Outcome Measures

Primary Outcomes (5)

• Number of participants referred to the Early Diagnostic Response Model (EDRM)

  Monthly numbers of high-risk referrals to the EDRM pilot project and total number of referrals made to the EDRM at the end of the study

  Until the end of the study (approximately one year)

• Number of participants consented in the Early Diagnostic Response Model (EDRM) study

  Monthly number of families referred who consent to EDRM participation

  Monthly until until the end of the study (approximately one year)

• Response rate in the Early Diagnostic Response Model (EDRM) study

  Response rate will be calculated at project end using the formula \[# of families who consented / # of families referred to project\] x 100 = response rate)

  Until end of the study (approximately one year)

• Number of participants that completed the Early Diagnostic Response Model (EDRM) study

  Quarterly numbers of participants that completed the EDRM assessment protocol and total number of participants who completed EDRM assessment protocol at study conclusion

  Every 3 months (Quarterly) until end of study (approximately one year)

• Time from referral to completion of the program

  Individual calculation of time from BCW referral to final summary report sent to family using the formula: Date of Final Report sent to family - Date of referral from BCW =Time in EDRM pilot

  Up to 12 weeks post-intervention

Secondary Outcomes (11)

• Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol

  Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention

• Number of of high-risk referral by BCW district

  Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention

• Number of of high-risk referral by child factors

  Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention

• Number of of high-risk referral by clinician setting

  Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention

• Number of participants with additional information collected to make a final DSM-5 conclusion

  Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention

Study Arms (1)

Families with children enrolled in BCW with suspected diagnosis of autism

EXPERIMENTAL

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).

Behavioral: Early Diagnostic Response Model (EDRM)

Interventions

Early Diagnostic Response Model (EDRM) BEHAVIORAL

Use of telehealth capabilities to implement measures and capture and code information related to an autism diagnosis. This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.

Families with children enrolled in BCW with suspected diagnosis of autism

Eligibility Criteria

• Age: 16 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Emory University: lead
• Georgia Department of Public Health: collaborator

Study Sites (1)

Emory Autism Center

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Allison Schwartz, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Schwartz, PhD

CONTACT

404.727.8350; allison.schwartz@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 15, 2022
• Study Start: June 16, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of the EDRM pilot project; Beginning 3 months and ending within 3 years of published results through peer-review process.
• Access Criteria: Researchers who provide a methodologically sound proposal that has been approved by an IRB. To achieve aims in proposed activity and/or for meta-analysis of telehealth assessments

Locations

US (1)