Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency in Georgia's Early Intervention Program

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-36
SponsorEmory University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Families with children enrolled in BCW with suspected diagnosis of autismExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Monthly until the end of the study (approximately one year)
2

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.

Time frame
End of study (up to 16 weeks post-intervention)
3

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

Time frame
Monthly until the end of the study (approximately one year)
4

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)

Time frame
Monthly until the end of the study (approximately one year)

Secondary outcomes

1

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.

Time frame
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
2

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.

Time frame
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
3

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.

Time frame
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
4

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

Time frame
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention

Other outcomes

Sponsors and contacts

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Emory University

Lead sponsor

Georgia Department of Public Health

Collaborator

This trial is not recruiting at the moment. You can still explore other options: