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NCT Number: NCT05419895

Early Diagnostic Response Model (EDRM)

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.

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Key information

Age range

16 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Autism Center

Atlanta, Georgia, 30322, United States

Location status: Recruiting

Location contact

Allison Schwartz, PhD

CONTACT

[email protected]

404.727.8350

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Early Diagnostic Response Model (EDRM)

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

Secondary outcomes

  1. 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 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.

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

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

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

  5. 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

  6. Parent satisfaction of EDRM assessment survey

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

    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.

  7. BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey

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

    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.

  8. Parent satisfaction with access to treatment survey

    Time frame: 3 months after completion of EDRM assessment

    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.

  9. 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

    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

  10. 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 screened high risk for ASD and referred for an evaluation

  11. 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 Schwartz, PhD

CONTACT

[email protected]

404.727.8350

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Georgia Department of Public Health

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2022
Registry last updated
Jun 10, 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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