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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. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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. .

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Andre navn:
  • EDRM-E

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of moderate and high-risk referral assessments that were completed entirely via a streamlined telehealth protocol
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere med tilleggsinformasjon samlet inn for å gjøre en endelig DSM-5-konklusjon
Tidsramme: Hver 3. måned (kvartalsvis) frem til studieslutt (ca. ett år), opptil 12 uker etter intervensjon
Antall deltakere med tilleggsinformasjon samlet inn for å gjøre en endelig DSM-5-konklusjon
Hver 3. måned (kvartalsvis) frem til studieslutt (ca. ett år), opptil 12 uker etter intervensjon
Antall familier som mottok ASD-evaluering ved slutten av studien gjennom piloten versus andre metoder
Tidsramme: Gjennom studiegjennomføring i snitt 1 år
Antall familier som mottok ASD-evaluering ved slutten av studien gjennom piloten versus andre metoder
Gjennom studiegjennomføring i snitt 1 år
Number of moderate and high-risk referrals by BCW district
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Emory University

Samarbeidspartnere

Georgia Department of Public Health

Etterforskere

  • Hovedetterforsker: Allison J Schwartz, PhD, Emory University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

29. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026P000244

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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