About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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. .
Trial design
Single group
Treatments tested in this trial
Early Diagnostic Response Model Expanded
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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.
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
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)
Secondary outcomes
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.
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.
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.
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
Sponsors and contacts
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Emory University
Lead sponsor
Georgia Department of Public Health
Collaborator
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