Early Diagnostic Response Model (EDRM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-36
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Early Diagnostic Response Model (EDRM)
BehavioralUse 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Families with children enrolled in BCW with suspected diagnosis of autismExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Until the end of the study (approximately one year)2
Number of participants consented in the Early Diagnostic Response Model (EDRM) study
Monthly number of families referred who consent to EDRM participation
Time frame
Monthly until until the end of the study (approximately one year)3
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)
Time frame
Until end of the study (approximately one year)4
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
Time frame
Every 3 months (Quarterly) until end of study (approximately one year)Secondary outcomes
1
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.
Time frame
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention2
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.
Time frame
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention3
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.
Time frame
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention4
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.
Time frame
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Georgia Department of Public Health
Collaborator
Source ClinicalTrials.gov