Autism Spectrum DisorderNCT05419895
Early Diagnostic Response Model (EDRM)
A study testing Early Diagnostic Response Model (EDRM) in people with Autism Spectrum Disorder and Autism, run by Emory University at 1 site in United States.
Trial summary
Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at… 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 (EDRM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to Jul 2028
- 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
- All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.
- Referring BCW provider must be one of the participating BCW health districts in this pilot study.
- Parent/Guardian needs to have basic English proficiency
- Parent/Guardian needs to have internet access
- Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).
- Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.
Who cannot join
- Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.
- Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.
- Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.
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, 1 recruiting
- Recruiting
Emory Autism Center
Atlanta, Georgia, 30322
Allison Schwartz, PhD, 404.727.8350, allison.schwartz@emory.edu
About this study
Official title: Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in Early Intervention Health Districts
Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.
Read the detailed description
The objective of this study is to develop, pilot, and evaluate a diagnostic protocol to assess high-risk toddlers for autism spectrum disorder (ASD) diagnosis of families enrolled in the Georgia Babies Can't Wait (BCW) early intervention program. The Early Diagnostic Response Model (EDRM) project will be addressing children who are identified at high risk for ASD according to the BCW screening protocol, which is the M-CHAT-R/F. Community psychologist will be taught the protocol and receive referrals to build capacity and better address the need across the state. Currently, many children who are screening high-risk for ASD in BCW districts are unable to access follow-up evaluations due to limited community resources and long wait times. It is hypothesized that the EDRM will be successful in increasing the number of BCW families that access an ASD evaluation using telehealth tools and testing protocols and that the families and clinicians involved will be satisfied with the streamlined process. The clinicians' conclusions from the EDRM assessment will be based on the Diagnostic and Statistical Manual, 5th edition (DSM-5; American Psychiatric Association [APA], 2013) and are hypothesized to be able to provide high-risk children and their families with the same access to services as an in-person assessment.
A secondary objective is to investigate how many high-risk referral assessments can be completed entirely via streamlined telehealth protocol and how many required additional information to be collected to make a final DSM-5 conclusion.
A tertiary objective is to investigate the improvement of the EDRM as an early identification model to assess for ASD by comparing the numbers of families screened high risk for ASD and referred for an evaluation prior to the study to the number of families who received ASD evaluation by the end of the study through the pilot versus other means. These numbers will be analyzed globally as well as by specific BCW district and other child factors.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Early Diagnostic Response Model (EDRM)
- Keywords
- Autism, Early Intervention, Telehealth, Assessment
- 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 (EDRM)Behavioural
Use of telehealth capabilities to implement measures and capture and code information related to an autism diagnosis. This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.
| 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. Then, the family will be assigned to a clinician for the autism assessment and scheduled their assessment and feedback session (one week later). Receives: Behavioral: Early Diagnostic Response Model (EDRM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants referred to the Early Diagnostic Response Model (EDRM)
Monthly numbers of high-risk referrals to the EDRM pilot project and total number of referrals made to the EDRM at the end of the study
Measured: Until the end of the study (approximately one year)
Number of participants consented in the Early Diagnostic Response Model (EDRM) study
Monthly number of families referred who consent to EDRM participation
Measured: Monthly until until the end of the study (approximately one year)
Response rate in the Early Diagnostic Response Model (EDRM) 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: Until end of the study (approximately one year)
Number of participants that completed the Early Diagnostic Response Model (EDRM) study
Quarterly numbers of participants that completed the EDRM assessment protocol and total number of participants who completed EDRM 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 pilot
Measured: Up to 12 weeks post-intervention
Secondary outcomes (11)
Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol
Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol, analyzed globally. Monthly, Quarterly, and Total numbers of participants who completed EDRM pilot assessment.
Measured: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
Number of of high-risk referral by BCW district
Number of high-risk referral assessments by specific BCW district. Monthly, Quarterly, and Total numbers of participants who completed EDRM pilot assessment.
Measured: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
Number of of 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 pilot assessment.
Measured: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
Number of of high-risk referral by clinician setting
Number of high-risk referral assessments by clinician setting. Monthly, Quarterly, and Total numbers of participants who completed EDRM 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 assessment survey
Administered at the end of individual EDRM 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 assessment (4 weeks post-intervention)
BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey
Administered at end of individual EDRM 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 assessment (4 weeks post-intervention)
Parent satisfaction with access to treatment survey
Administered 3-months after completion of EDRM 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 15.
Measured: 3 months after completion of EDRM assessment
BCW provider(s) Early Intervention Coordinator satisfaction with EDRM 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 high risk for ASD and referred for an evaluation
Number of families screened 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 posted15 Jun 2022
- Study start16 Jun 2022
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (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
- 300 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 Schwartz, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419895
- Sponsor's protocol ID
- STUDY00003763
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the EDRM pilot will be shared, after de-identification process has been completed. 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in Early Intervention Health Districts
- ClinicalTrials.gov ID
- NCT05419895
- Acronym / sponsor ID
- STUDY00003763
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Autism, Early Intervention, Telehealth, Assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Department of Public Health
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 15 Jun 2022 (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.
Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.
Detailed description
The objective of this study is to develop, pilot, and evaluate a diagnostic protocol to assess high-risk toddlers for autism spectrum disorder (ASD) diagnosis of families enrolled in the Georgia Babies Can't Wait (BCW) early intervention program. The Early Diagnostic Response Model (EDRM) project will be addressing children who are identified at high risk for ASD according to the BCW screening protocol, which is the M-CHAT-R/F. Community psychologist will be taught the protocol and receive referrals to build capacity and better address the need across the state. Currently, many children who are screening high-risk for ASD in BCW districts are unable to access follow-up evaluations due to limited community resources and long wait times. It is hypothesized that the EDRM will be successful in increasing the number of BCW families that access an ASD evaluation using telehealth tools and testing protocols and that the families and clinicians involved will be satisfied with the streamlined process. The clinicians' conclusions from the EDRM assessment will be based on the Diagnostic and Statistical Manual, 5th edition (DSM-5; American Psychiatric Association [APA], 2013) and are hypothesized to be able to provide high-risk children and their families with the same access to services as an in-person assessment.
A secondary objective is to investigate how many high-risk referral assessments can be completed entirely via streamlined telehealth protocol and how many required additional information to be collected to make a final DSM-5 conclusion.
A tertiary objective is to investigate the improvement of the EDRM as an early identification model to assess for ASD by comparing the numbers of families screened high risk for ASD and referred for an evaluation prior to the study to the number of families who received ASD evaluation by the end of the study through the pilot versus other means. These numbers will be analyzed globally as well as by specific BCW district and other child factors.
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 (EDRM)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. Then, the family will be assigned to a clinician for the autism assessment and scheduled their assessment and feedback session (one week later). |
Who may qualify
- Ages
- 16 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.
- Referring BCW provider must be one of the participating BCW health districts in this pilot study.
- Parent/Guardian needs to have basic English proficiency
- Parent/Guardian needs to have internet access
- Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).
Key exclusion criteria (3 listed)
- Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.
- Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.
- Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.
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 (EDRM)Use of telehealth capabilities to implement measures and capture and code information related to an autism diagnosis. This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot. | Behavioural | Families with children enrolled in BCW with suspected diagnosis of autism |
Primary outcome
Number of participants referred to the Early Diagnostic Response Model (EDRM)
Time frame: Until the end of the study (approximately one year)
Monthly numbers of high-risk referrals to the EDRM pilot project and total number of referrals made to the EDRM at the end of the study
Number of participants consented in the Early Diagnostic Response Model (EDRM) study
Time frame: Monthly until until the end of the study (approximately one year)
Monthly number of families referred who consent to EDRM participation
Response rate in the Early Diagnostic Response Model (EDRM) study
Time frame: Until 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 (EDRM) study
Time frame: Every 3 months (Quarterly) until end of study (approximately one year)
Quarterly numbers of participants that completed the EDRM assessment protocol and total number of participants who completed EDRM 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 pilot
11 secondary outcomes
Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol
Time frame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
Number of of high-risk referral by BCW district
Time frame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
Number of of 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 of high-risk referral 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 assessment survey
Time frame: At completion of EDRM assessment (4 weeks post-intervention)
BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey
Time frame: At completion of EDRM assessment (4 weeks post-intervention)
Parent satisfaction with access to treatment survey
Time frame: 3 months after completion of EDRM assessment
BCW provider(s) Early Intervention Coordinator satisfaction with EDRM pilot survey
Time frame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention
Number of families screened 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 10 Jun 2026.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the EDRM pilot will be shared, after de-identification process has been completed. 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.
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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 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 (EDRM) 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: looking for participants now, as of the sponsor's last update on 10 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 Schwartz, PhD (404.727.8350, 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 participants referred to the Early Diagnostic Response Model (EDRM) (time frame: Until the end of the study (approximately one year)). The study lists 5 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 10 Jun 2026.