Clinical trial NCT05419895: Early Diagnostic Response Model (EDRM)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: Autism
Early Intervention
Telehealth
Assessment
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Department of Public Health
First posted: 2022-06-15
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants referred to the Early Diagnostic Response Model (EDRM)
timeFrame: Until the end of the study (approximately one year)
measure: Number of participants consented in the Early Diagnostic Response Model (EDRM) study
timeFrame: Monthly until until the end of the study (approximately one year)
measure: Response rate in the Early Diagnostic Response Model (EDRM) study
timeFrame: Until end of the study (approximately one year)
measure: Number of participants that completed the Early Diagnostic Response Model (EDRM) study
timeFrame: Every 3 months (Quarterly) until end of study (approximately one year)
measure: Time from referral to completion of the program
timeFrame: Up to 12 weeks post-intervention
Secondary outcomes:
measure: Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol
timeFrame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
measure: Number of of high-risk referral by BCW district
timeFrame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
measure: Number of of high-risk referral by child factors
timeFrame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
measure: Number of of high-risk referral by clinician setting
timeFrame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
measure: Number of participants with additional information collected to make a final DSM-5 conclusion
timeFrame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
measure: Parent satisfaction of EDRM assessment survey
timeFrame: At completion of EDRM assessment (4 weeks post-intervention)
measure: BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey
timeFrame: At completion of EDRM assessment (4 weeks post-intervention)
measure: Parent satisfaction with access to treatment survey
timeFrame: 3 months after completion of EDRM assessment
measure: BCW provider(s) Early Intervention Coordinator satisfaction with EDRM pilot survey
timeFrame: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention
measure: Number of families screened high risk for ASD and referred for an evaluation
timeFrame: Through study completion, an average of 1 year
measure: Number of families who received ASD evaluation by the end of the study through the pilot versus other means
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: Allison Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References: