Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT05419895

Conditions

Autism Spectrum Disorder

Autism

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Not accepted

Interventions

Early Diagnostic Response Model (EDRM)

Study Details

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

Study ID

NCT05419895

Start date

Jun 16, 2022

Status verified date

Jun, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Not accepted

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 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.

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 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.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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).

Interventions

Early Diagnostic Response Model (EDRM)

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.

Primary outcome measure

  • Number of participants referred to the Early Diagnostic Response Model (EDRM) [ Time Frame: Until the end of the study (approximately one year) ]
  • Number of participants consented in the Early Diagnostic Response Model (EDRM) study [ Time Frame: Monthly until until the end of the study (approximately one year) ]
  • Response rate in the Early Diagnostic Response Model (EDRM) study [ Time Frame: Until end of the study (approximately one year) ]
  • Number of participants that completed the Early Diagnostic Response Model (EDRM) study [ Time Frame: Every 3 months (Quarterly) until end of study (approximately one year) ]
  • Time from referral to completion of the program [ Time Frame: Up to 12 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Allison Schwartz, PhD

404.727.8350allison.schwartz@emory.edu

Locations

Emory Autism Center

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Allison Schwartz, PhD

404.727.8350allison.schwartz@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Autism
  • Early Intervention
  • Telehealth
  • Assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-10.