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

29 mei 2026 bijgewerkt door: Allison Schwartz, Emory University

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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. .

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Families with children enrolled in BCW with suspected diagnosis of autism
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.
Gedragsmatig: Early 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.
Andere namen:
  • EDRM-E

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of moderate and high-risk referral assessments that were completed entirely via a streamlined telehealth protocol
Tijdsspanne: 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
Monthly until the end of the study (approximately one year)
Number of participants referred to the Early Diagnostic Response Model Expanded (EDRM-E)
Tijdsspanne: 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.
End of study (up to 16 weeks post-intervention)
Number of participants consented in the Early Diagnostic Response Model Expanded (EDRM-E) study
Tijdsspanne: Monthly until the end of the study (approximately one year)
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
Tijdsspanne: 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)
Monthly until the end of the study (approximately one year)
Number of participants that completed the Early Diagnostic Response Model Expanded (EDRM-E) study
Tijdsspanne: 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
Every 3 months (Quarterly) until end of study (approximately one year)
Time from referral to completion of the program
Tijdsspanne: 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
Up to 12 weeks post-intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Aantal deelnemers waarbij aanvullende informatie is verzameld om tot een definitieve DSM-5-conclusie te komen
Tijdsspanne: Elke 3 maanden (driemaandelijks) tot het einde van de studie (ongeveer een jaar), tot 12 weken na de interventie
Aantal deelnemers waarbij aanvullende informatie is verzameld om tot een definitieve DSM-5-conclusie te komen
Elke 3 maanden (driemaandelijks) tot het einde van de studie (ongeveer een jaar), tot 12 weken na de interventie
Aantal gezinnen dat aan het einde van het onderzoek een ASS-evaluatie ontving via de pilot versus andere middelen
Tijdsspanne: Via afronding van de studie, gemiddeld 1 jaar
Aantal gezinnen dat aan het einde van het onderzoek een ASS-evaluatie ontving via de pilot versus andere middelen
Via afronding van de studie, gemiddeld 1 jaar
Number of moderate and high-risk referrals by BCW district
Tijdsspanne: 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.
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
Number of moderate and high-risk referral by child factors
Tijdsspanne: 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.
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
Tijdsspanne: 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.
Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
Parent satisfaction of EDRM-E assessment survey
Tijdsspanne: 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.
At completion of EDRM-E assessment (4 weeks post-intervention)
BCW provider(s) Service Coordinator satisfaction with EDRM-E assessment survey
Tijdsspanne: 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.
At completion of EDRM-E assessment (4 weeks post-intervention)
Parent satisfaction with access to treatment survey
Tijdsspanne: 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.
3 months after completion of EDRM-E assessment
BCW provider(s) Early Intervention Coordinator satisfaction with EDRM-E pilot survey
Tijdsspanne: 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
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
Tijdsspanne: Through study completion, an average of 1 year
Number of families screened moderate and high-risk for ASD and referred for an evaluation
Through study completion, an average of 1 year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Emory University

Medewerkers

Georgia Department of Public Health

Onderzoekers

  • Hoofdonderzoeker: Allison J Schwartz, PhD, Emory University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026P000244

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Klinische onderzoeken op Early Diagnostic Response Model Expanded

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