Early Diagnostic Response Model (EDRM)

Study Overview
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Brief Summary
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Three districts of Babies Can't Wait (BCW) 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
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The objective of this study is to develop, pilot, and evaluate a diagnostic protocol to assess high-risk infants and children for autism diagnosis for families with young children enrolled in the Georgia BCW early intervention program. The Early Diagnostic Response Model (EDRM) project will be addressing children who are identified at high risk for autism according to the BCW screening protocol, which is the M-CHAT-R. Currently, many children who are screening high-risk for autism 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 autism assessment 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, Text revision (DSM-5-TR; 2022) and are hypothesized to be able to provide 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 needed additional information collected to make a final DSM-5-TR conclusion. Results of this study will provide meaningful data on the validity of partnering with early intervention (EI) and using telehealth technology for families to receive a diagnosis of autism, and to diagnose and start EI services specifically aimed at autism symptoms when needed.

Official Title
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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

Conditions
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Autism Spectrum Disorder, Autism

Intervention / Treatment
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* Behavioral: Early Diagnostic Response Model (EDRM)


Participation Criteria
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Eligibility Criteria
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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 high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.

Ages Eligible for Study
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Minimum Age: 16 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Families with children with suspected diagnosis of autism<br>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)<br>* Use of telehealth capabilities to 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.<br>|

What is the study measuring?
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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 high-risk referral assessments that completed entirely via streamlined telehealth protocol | Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol. 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Early Intervention, Telehealth, Assessment