Autism, Autism Spectrum Disorder
Conditions
Keywords
Autism, Early Intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEarly Diagnostic Response Model Expanded
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.
Sponsors
Emory University
Georgia Department of Public Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
* Child is enrolled in a participating BCW district. * Child is 16-36 months of age at the time of referral. * Child is identified as moderate- or high-risk on the M-CHAT-R/F * BCW provider submits a referral to the EDRM-E pilot by 33 months of age. * Parent/guardian has basic English proficiency in order to complete intake forms and in-depth interview, and the child has exposure to English at home or in out-of-home care. * Documentation of the M-CHAT-R/F screening results and parental consent to refer is completed and submitted.
Exclusion criteria
* Families making self-referrals to the EAC or referred from non-onboarded BCW districts. * Child is older than 33 months at referral. * Non-English speaking families due to staffing and resource limitations as the consent, parent interview and child assessment would need to be done and accessible in other languages and are not available within this study scope at this time. .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of moderate and high-risk referral assessments that were completed entirely via a streamlined telehealth protocol | Monthly until the end of the study (approximately one year) | Number of moderate and high-risk referral assessments that can be completed entirely via streamlined telehealth protocol |
| Number of participants referred to the Early Diagnostic Response Model Expanded (EDRM-E) | End of study (up to 16 weeks post-intervention) | 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. |
| Number of participants consented in the Early Diagnostic Response Model Expanded (EDRM-E) study | Monthly until the end of the study (approximately one year) | Monthly number of families referred who consent to EDRM-E participation |
| Response rate in the Early Diagnostic Response Model Expanded (EDRM-E) study | Monthly until the 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) |
| Number of participants that completed the Early Diagnostic Response Model Expanded (EDRM-E) study | Every 3 months (Quarterly) until end of study (approximately one year) | 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 |
| Time from referral to completion of the program | 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-E pilot |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of moderate and high-risk referrals by BCW district | Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention | Number of moderate-high risk referral assessments by specific BCW district. Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment. |
| Number of moderate and high-risk referral by child factors | 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-E pilot assessment. |
| Number of moderate and high-risk referrals by clinician setting | 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-E pilot assessment. |
| 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 | Number of participants with additional information collected to make a final DSM-5 conclusion |
| Parent satisfaction of EDRM-E assessment survey | At completion of EDRM-E assessment (4 weeks post-intervention) | 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. |
| BCW provider(s) Service Coordinator satisfaction with EDRM-E assessment survey | At completion of EDRM-E assessment (4 weeks post-intervention) | 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. |
| Parent satisfaction with access to treatment survey | 3 months after completion of EDRM-E assessment | 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. |
| BCW provider(s) Early Intervention Coordinator satisfaction with EDRM-E pilot survey | 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 |
| 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 screened moderate and high-risk for ASD and referred for an evaluation |
| 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 | Number of families who received ASD evaluation by the end of the study through the pilot versus other means |
Countries
United States
Contacts
CONTACTAllison J Schwartz, PhD
PRINCIPAL_INVESTIGATORAllison J Schwartz, PhD
Emory University
Outcome results
None listed