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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Early Diagnostic Response Model Expanded

Detailed Description

The objective of this study is to develop, pilot, and evaluate 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.

Many BCW children with moderate- or high-risk screening results face long wait times and limited access to diagnostic evaluations. This pilot will evaluate how many of these assessments can be completed entirely via a streamlined telehealth protocol and the level of diagnostic confidence achieved. It is hypothesized that the EDRM-E will increase access to timely, evidence-based autism evaluations and yield diagnostic outcomes comparable to in-person assessments based on DSM-5-TR criteria.

Secondary aims include identifying which additional assessment measures increase clinician confidence and are most acceptable to families and providers. It is hypothesized that moderate-risk children will require more in-depth evaluation and that families receiving expanded assessments will report higher satisfaction and acceptability.

A further objective is to examine family, BCW provider, and clinician satisfaction, understanding, and access to services following participation in the EDRM-E pilot. No data will be submitted to the FDA, and no algorithm, product, or software will be commercialized or used outside Emory.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison J Schwartz, PhD; Phone Number: 404-727-6865; Email: allison.schwartz@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
      • Contact: Allison J Schwartz, PhD; Phone Number: 404-727-6865; Email: allison.schwartz@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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. .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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. 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; 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.; Other Names: EDRM-E

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with additional information collected to make a final DSM-5 conclusion	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
Number of families who received ASD evaluation by the end of the study through the pilot versus other means	Number of families who received ASD evaluation by the end of the study through the pilot versus other means	Through study completion, an average of 1 year
Number of moderate and high-risk referrals by BCW district	Number of moderate-high risk referral assessments by specific BCW district. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.	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	Number of high-risk referral assessments by child factors. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.	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	Number of high-risk referral assessments by clinician setting. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.	Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
Parent satisfaction of EDRM-E assessment survey	Administered at the end of individual EDRM-E assessment. Satisfaction surveys will use a Likert-scale of 1-5 with 1 being strongly disagree and 5 being strongly agree as well as 0 being not applicable/unknown. Higher scores indicate more satisfaction with specific aspect of EDRM project. Total score: 0 to 110.	At completion of EDRM-E assessment (4 weeks post-intervention)
BCW provider(s) Service Coordinator satisfaction with EDRM-E assessment survey	Administered at end of individual EDRM-E assessment. Satisfaction surveys will use a Likert-scale of 1-5 with 1 being strongly disagree and 5 being strongly agree as well as 0 being not applicable/unknown. Higher scores indicate more satisfaction with specific aspect of EDRM-E project.	At completion of EDRM-E assessment (4 weeks post-intervention)
Parent satisfaction with access to treatment survey	Parent satisfaction with access to treatment survey Administered 3-months after completion of EDRM-E assessment. Satisfaction surveys will use a Likert-scale of 1-5 with 1 being strongly disagree and 5 being strongly agree as well as 0 being not applicable/unknown. Higher scores indicate more satisfaction with specific aspect of EDRM-E project. Total score: 0 to 15.	3 months after completion of EDRM-E assessment
BCW provider(s) Early Intervention Coordinator satisfaction with EDRM-E pilot survey	Completed every 3 months (Quarterly). Satisfaction surveys will use a Likert-scale of 1-5 with 1 being strongly disagree and 5 being strongly agree as well as 0 being not applicable/unknown. Higher scores indicate more satisfaction with specific aspect of EDRM project. Total score: 0 to 55	Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention
Number of families screened moderate and high-risk for ASD and referred for an evaluation	Number of families screened moderate and high-risk for ASD and referred for an evaluation	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Georgia Department of Public Health
• Investigators: Principal Investigator: Allison J Schwartz, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Autism; Early Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: 2026P000244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with qualified researchers with relevant expertise, researchers affiliated with academic or clinical institutions, and investigators with IRB/ethics approval for secondary analyses as needed, including basic demographic information, scores on assessments, and final diagnostic results.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No