Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Georgia Department of Public Health | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Families with children enrolled in BCW with suspected diagnosis of autism | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Diagnostic Response Model (EDRM) | Behavioral | 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. |
| 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 |
| 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, 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Schwartz, PhD | Contact | 404.727.8350 | allison.schwartz@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allison Schwartz, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Autism Center | Recruiting | Atlanta | Georgia | 30322 | United States |
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.
After completion of the EDRM pilot project; Beginning 3 months and ending within 3 years of published results through peer-review process.
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
Not provided
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 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 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 |