Emory Autism Center
Atlanta, Georgia, 30322, United States
Location status: Recruiting
NCT Number: NCT05419895
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.
Interested in participating?
Request Info16 month–36 month
All sexes
Interventional
Not applicable
Atlanta, Georgia, 30322, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Monthly until until the end of the study (approximately one year)
Monthly number of families referred who consent to EDRM participation
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)
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 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
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.
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.
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.
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.
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: 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.
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.
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.
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
Time frame: Through study completion, an average of 1 year
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
Contact information is provided by the study sponsor or research team.
Emory University
Other
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
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