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| Name | Class |
|---|---|
| Georgia Department of Public Health | UNKNOWN |
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This pilot study includes children identified as moderate- as well as high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program. The project will evaluate the feasibility, acceptability, and implementation of a diagnostic protocol, including optional measures, through measures of recruitment, retention, adherence, provider confidence, and time from referral to report completion. It will also examine which child diagnostic measures are essential and needed to improve psychologists' diagnostic confidence. Caregiver, early intervention provider, and clinician experiences and satisfaction before, during, and after assessment will be assessed to evaluate protocol acceptability, knowledge, and access to services. Outcomes will be analyzed using the RE-AIM Framework (reach, effectiveness, adoption, implementation, maintenance) and compared across BCW districts and child characteristics, including changes in autism screening, referral, and evaluation rates over time.
The objective of this study is to develop, pilot, and evaluate a telehealth diagnostic protocol for assessing toddlers identified as moderate- or high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program.
Many BCW children with moderate- or high-risk screening results face long wait times and limited access to diagnostic evaluations. This pilot will evaluate how many of these assessments can be completed entirely via a streamlined telehealth protocol and the level of diagnostic confidence achieved. It is hypothesized that the EDRM-E will increase access to timely, evidence-based autism evaluations and yield diagnostic outcomes comparable to in-person assessments based on DSM-5-TR criteria.
Secondary aims include identifying which additional assessment measures increase clinician confidence and are most acceptable to families and providers. It is hypothesized that moderate-risk children will require more in-depth evaluation and that families receiving expanded assessments will report higher satisfaction and acceptability.
A further objective is to examine family, BCW provider, and clinician satisfaction, understanding, and access to services following participation in the EDRM-E pilot. No data will be submitted to the FDA, and no algorithm, product, or software will be commercialized or used outside Emory.
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| 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. Children will be assessed via a remote telehealth session with an EAC clinician, using age-appropriate standardized measures. Clinicians rate confidence after four points: intake review, parent interview and child observation, child assessment, and DSM-5-TR checklist completion. Feedback is provided via telehealth, and a final report with recommendations is issued. Psychologists will be asked about the protocol after each assessment. Parents/caregivers will be asked to answer questions during the assessment, immediately after the assessment, and 3 months later. EI providers will also be asked questions about their experience after the assessment. Total length of enrollment range 3-16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Diagnostic Response Model Expanded | Behavioral | A telehealth diagnostic protocol for assessing toddlers identified as moderate- or high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program. This pilot will evaluate how many of the initial assessments can be completed entirely via a streamlined telehealth protocol and the level of diagnostic confidence achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of moderate and high-risk referral assessments that were completed entirely via a streamlined telehealth protocol | Number of moderate and high-risk referral assessments that can be completed entirely via streamlined telehealth protocol | Monthly until the end of the study (approximately one year) |
| Number of participants referred to the Early Diagnostic Response Model Expanded (EDRM-E) | Monthly numbers of high-risk referrals to the EDRM-E pilot project and total number of referrals made to the EDRM-E at the end of the study. | End of study (up to 16 weeks post-intervention) |
| Number of participants consented in the Early Diagnostic Response Model Expanded (EDRM-E) study | Monthly number of families referred who consent to EDRM-E participation | Monthly until the end of the study (approximately one year) |
| Response rate in the Early Diagnostic Response Model Expanded (EDRM-E) 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) | Monthly until the end of the study (approximately one year) |
| Number of participants that completed the Early Diagnostic Response Model Expanded (EDRM-E) study | Quarterly numbers of participants that completed the EDRM-E assessment protocol and total number of participants who completed EDRM-E assessment protocol at study conclusion | Every 3 months (Quarterly) until end of study (approximately one year) |
| Time from referral to completion of the program |
| Measure | Description | Time Frame |
|---|---|---|
| Number of moderate and high-risk referrals by BCW district | Number of moderate-high risk referral assessments by specific BCW district. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment. | Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison J Schwartz, PhD | Contact | 404-727-6865 | allison.schwartz@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allison J Schwartz, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
Data will be shared with qualified researchers with relevant expertise, researchers affiliated with academic or clinical institutions, and investigators with IRB/ethics approval for secondary analyses as needed, including basic demographic information, scores on assessments, and final diagnostic results.
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.
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.
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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-E pilot
| Up to 12 weeks post-intervention |
| Number of moderate and 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-E pilot assessment. |
| Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention |
| Number of moderate and high-risk referrals by clinician setting | Number of high-risk referral assessments by clinician setting. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E 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-E assessment survey | Administered at the end of individual EDRM-E 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-E assessment (4 weeks post-intervention) |
| BCW provider(s) Service Coordinator satisfaction with EDRM-E assessment survey | Administered at end of individual EDRM-E 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-E project. | At completion of EDRM-E assessment (4 weeks post-intervention) |
| Parent satisfaction with access to treatment survey | Parent satisfaction with access to treatment survey Administered 3-months after completion of EDRM-E 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-E project. Total score: 0 to 15. | 3 months after completion of EDRM-E assessment |
| BCW provider(s) Early Intervention Coordinator satisfaction with EDRM-E 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 moderate and high-risk for ASD and referred for an evaluation | Number of families screened moderate and 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 |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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