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

NCT07623759 | Not Yet Recruiting

• 1 other identifier: 2026P000244
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Autism

Keywords

Autism; Early Intervention

Outcome Measures

Primary Outcomes (6)

• Number of moderate and high-risk referral assessments that were completed entirely via a streamlined telehealth protocol

  Number of moderate and high-risk referral assessments that can be completed entirely via streamlined telehealth protocol

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

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

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

  End of study (up to 16 weeks post-intervention)

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

  Monthly number of families referred who consent to EDRM-E participation

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

• Response rate in the Early Diagnostic Response Model Expanded (EDRM-E) 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)

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

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

  Quarterly numbers of participants that completed the EDRM-E assessment protocol and total number of participants who completed EDRM-E 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-E pilot

  Up to 12 weeks post-intervention

Secondary Outcomes (10)

• Number of moderate and high-risk referrals by BCW district

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

• Number of moderate and 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 moderate and high-risk referrals 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

• Parent satisfaction of EDRM-E assessment survey

  At completion of EDRM-E assessment (4 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. Children will be assessed via a remote telehealth session with an EAC clinician, using age-appropriate standardized measures. Clinicians rate confidence after four points: intake review, parent interview and child observation, child assessment, and DSM-5-TR checklist completion. Feedback is provided via telehealth, and a final report with recommendations is issued. Psychologists will be asked about the protocol after each assessment. Parents/caregivers will be asked to answer questions during the assessment, immediately after the assessment, and 3 months later. EI providers will also be asked questions about their experience after the assessment. Total length of enrollment range 3-16 weeks.

Behavioral: Early Diagnostic Response Model Expanded

Interventions

Early Diagnostic Response Model Expanded 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.

Also known as: EDRM-E

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:

• 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 may not qualify 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. .

Sponsors & Collaborators

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

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Allison J Schwartz, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison J Schwartz, PhD

CONTACT

404-727-6865; 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: May 29, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Proposals may be submitted to up to 3 years following article publication. After 3 years, data will be provided in Emory University's data warehouse but without investigator support other than deposited materials.
• 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)