Early Diagnostic Response Model (EDRM)

Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in 3 Pilot 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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Early Diagnostic Response Model (EDRM)

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison Schwartz, PhD; Phone Number: 404.727.8350; Email: allison.schwartz@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory Autism Center
      • Contact: Allison Schwartz, PhD; Phone Number: 404-727-8350; Email: allison.schwartz@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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 three targeted BCW districts participating 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.

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. Then, the family will be assigned to a clinician for the autism assessment and scheduled their assessment and feedback session (one week later).

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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	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	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
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.	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.	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.	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	Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention
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.	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.	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.	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.	Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
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	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	Through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Assessment; Telehealth; Autism; Early Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: STUDY00003763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: After completion of the EDRM pilot project; Beginning 3 months and ending within 3 years of published results through peer-review process.
• 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