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NCT Number: NCT07623759

Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency 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.

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Key information

Conditions

Autism Spectrum Disorder Autism Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

16 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. .

Treatment and study plan

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.

Other names: EDRM-E

Primary outcomes

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

    Time frame: Monthly until the end of the study (approximately one year)

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

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

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

    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.

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

    Time frame: Monthly until the end of the study (approximately one year)

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

  4. Response rate in the Early Diagnostic Response Model Expanded (EDRM-E) study

    Time frame: Monthly until the end of the study (approximately one year)

    Response rate will be calculated at project end using the formula [# of families who consented / # of families referred to project] x 100 = response rate)

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

    Time frame: Every 3 months (Quarterly) until end of study (approximately one year)

    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

  6. Time from referral to completion of the program

    Time frame: Up to 12 weeks post-intervention

    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

Secondary outcomes

  1. Number of moderate and high-risk referrals by BCW district

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

    Number of moderate-high risk referral assessments by specific BCW district. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.

  2. Number of moderate and high-risk referral by child factors

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

    Number of high-risk referral assessments by child factors. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.

  3. Number of moderate and high-risk referrals by clinician setting

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

    Number of high-risk referral assessments by clinician setting. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.

  4. Number of participants with additional information collected to make a final DSM-5 conclusion

    Time frame: 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

  5. Parent satisfaction of EDRM-E assessment survey

    Time frame: At completion of EDRM-E assessment (4 weeks post-intervention)

    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.

  6. BCW provider(s) Service Coordinator satisfaction with EDRM-E assessment survey

    Time frame: At completion of EDRM-E assessment (4 weeks post-intervention)

    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.

  7. Parent satisfaction with access to treatment survey

    Time frame: 3 months after completion of EDRM-E assessment

    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.

  8. BCW provider(s) Early Intervention Coordinator satisfaction with EDRM-E pilot survey

    Time frame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention

    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

  9. Number of families screened moderate and high-risk for ASD and referred for an evaluation

    Time frame: Through study completion, an average of 1 year

    Number of families screened moderate and high-risk for ASD and referred for an evaluation

  10. Number of families who received ASD evaluation by the end of the study through the pilot versus other means

    Time frame: Through study completion, an average of 1 year

    Number of families who received ASD evaluation by the end of the study through the pilot versus other means

Study contacts

Contact information is provided by the study sponsor or research team.

Allison J Schwartz, PhD

CONTACT

[email protected]

404-727-6865

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Georgia Department of Public Health

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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