What this study is
This pilot study includes children identified as moderate- as well as high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program. The project will evaluate the feasibility, acceptability, and implementation of a diagnostic protocol, including optional measures, through measures of recruitment, retention, adherence, provider confidence, and time from referral to report completion. It will also examine which child diagnostic measures are essential and needed to improve psychologists' diagnostic confidence. Caregiver, early intervention provider, and clinician experiences and satisfaction before, during, and after assessment will be assessed to evaluate protocol acceptability, knowledge, and access to services. Outcomes will be analyzed using the RE-AIM Framework (reach, effectiveness, adoption, implementation, maintenance) and compared across BCW districts and child characteristics, including changes in autism screening, referral, and evaluation rates over time.
What's being tested
- Early Diagnostic Response Model Expanded
Intervention · BEHAVIORAL
A telehealth diagnostic protocol for assessing toddlers identified as moderate- or high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program. This pilot will evaluate how many of the initial assessments can be completed entirely via a streamlined telehealth protocol and the level of diagnostic confidence achieved.
Study details
- Official title
- Early Diagnostic Telehealth Pilot for Moderate- and High-risk Children: Evaluating Protocols for Children in Georgia's Early Intervention Program
- Sponsor
- Emory University
- Conditions
- Autism Spectrum Disorder · Autism
- Enrolling
- 100 people
- Starts
- 2026-06
- Est. completion
- 2027-06
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 16 Months – 36 MonthsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Child is enrolled in a participating BCW district.
- Child is 16-36 months of age at the time of referral.
- Child is identified as moderate- or high-risk on the M-CHAT-R/F
- BCW provider submits a referral to the EDRM-E pilot by 33 months of age.
- Parent/guardian has basic English proficiency in order to complete intake forms and in-depth interview, and the child has exposure to English at home or in out-of-home care.
- Documentation of the M-CHAT-R/F screening results and parental consent to refer is completed and submitted.
You can't join if
- Families making self-referrals to the EAC or referred from non-onboarded BCW districts.
- Child is older than 33 months at referral.
- Non-English speaking families due to staffing and resource limitations as the consent, parent interview and child assessment would need to be done and accessible in other languages and are not available within this study scope at this time. .
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openEmory University
Atlanta, Georgia, United States
- Allison J Schwartz, PhD · Contact404-727-6865allison.schwartz@emory.edu
Study team
Sponsor
Emory University
Study ID 2026P000244
Principal investigator
Allison J Schwartz, PhD
Emory University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.