Autism Spectrum DisorderNCT07623759
Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency in Georgia's Early Intervention Program
A study testing Early Diagnostic Response Model Expanded in people with Autism Spectrum Disorder and Autism, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 36 months
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Early Diagnostic Response Model Expanded
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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. .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Emory University
Atlanta, Georgia, 30322
Allison J Schwartz, PhD, 404-727-6865, allison.schwartz@emory.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Early Diagnostic Response Model Expanded
- Keywords
- Autism, Early Intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Diagnostic Response Model ExpandedBehavioural
Also called EDRM-E
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Early Diagnostic Response Model Expanded |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Up to 12 weeks post-intervention
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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
Number of participants with additional information collected to make a final DSM-5 conclusion
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Number of families who received ASD evaluation by the end of the study through the pilot versus other means
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Department of Public Health
- Responsible party
- Principal investigator, Allison Schwartz, Emory University
- Investigators
- Allison J Schwartz, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623759
- Sponsor's protocol ID
- 2026P000244
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnostic Telehealth Pilot for Moderate- and High-risk Children: Evaluating Protocols for Children in Georgia's Early Intervention Program
- ClinicalTrials.gov ID
- NCT07623759
- Acronym / sponsor ID
- 2026P000244
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Autism, Early Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Department of Public Health
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families with children enrolled in BCW with suspected diagnosis of autism | Experimental | Behavioral: Early Diagnostic Response Model ExpandedPost-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. |
Who may qualify
- Ages
- 16 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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. .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Diagnostic Response Model ExpandedAlso: EDRM-EA 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. | Behavioural | Families with children enrolled in BCW with suspected diagnosis of autism |
Primary outcome
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
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.
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
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)
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
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
10 secondary outcomes
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 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 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 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
Parent satisfaction of EDRM-E assessment survey
Time frame: At completion of EDRM-E assessment (4 weeks post-intervention)
BCW provider(s) Service Coordinator satisfaction with EDRM-E assessment survey
Time frame: At completion of EDRM-E assessment (4 weeks post-intervention)
Parent satisfaction with access to treatment survey
Time frame: 3 months after completion of EDRM-E assessment
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
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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison J Schwartz, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Diagnostic Response Model Expanded in people with Autism Spectrum Disorder and Autism, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison J Schwartz, PhD (404-727-6865, allison.schwartz@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.