Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

29 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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. .

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: 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.
Otros nombres:
  • EDRM-E

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of moderate and high-risk referral assessments that were completed entirely via a streamlined telehealth protocol
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Número de participantes con información adicional recopilada para llegar a una conclusión final del DSM-5
Periodo de tiempo: Cada 3 meses (trimestral) hasta el final del estudio (aproximadamente un año), hasta 12 semanas después de la intervención
Número de participantes con información adicional recopilada para llegar a una conclusión final del DSM-5
Cada 3 meses (trimestral) hasta el final del estudio (aproximadamente un año), hasta 12 semanas después de la intervención
Número de familias que recibieron una evaluación del TEA al final del estudio a través del piloto versus otros medios
Periodo de tiempo: Hasta la finalización del estudio, un promedio de 1 año.
Número de familias que recibieron una evaluación del TEA al final del estudio a través del piloto versus otros medios
Hasta la finalización del estudio, un promedio de 1 año.
Number of moderate and high-risk referrals by BCW district
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Emory University

Colaboradores

Georgia Department of Public Health

Investigadores

  • Investigador principal: Allison J Schwartz, PhD, Emory University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de mayo de 2026

Publicado por primera vez (Actual)

3 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026P000244

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Desorden del espectro autista

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Cote d'Ivoire

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

Suscribir