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NCT07623759Not yet recruiting

Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency in Georgia's Early Intervention Program

Early Diagnostic Telehealth Pilot for Moderate- and High-risk Children: Evaluating Protocols for Children in Georgia's Early Intervention Program

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
29 May 2026
Start date
1 Jun 2026
Primary completion date
30 Jun 2027
Lead sponsor
Emory University
Diseases
Autism
NCT number
NCT07623759

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Jun 2026 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Child is older than 33 months at referral.

Other

  • Families making self-referrals to the EAC or referred from non-onboarded BCW districts.
  • 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. .

Who the study is looking for

  • 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.

Age in the registry: 16 months to 36 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.