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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (10)

• Number of moderate and high-risk referrals by BCW district [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention]
• Number of participants with additional information collected to make a final DSM-5 conclusion [Срок оценки: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention]
• Parent satisfaction of EDRM-E assessment survey [Срок оценки: At completion of EDRM-E assessment (4 weeks post-intervention)]
• BCW provider(s) Service Coordinator satisfaction with EDRM-E assessment survey [Срок оценки: At completion of EDRM-E assessment (4 weeks post-intervention)]
• Parent satisfaction with access to treatment survey [Срок оценки: 3 months after completion of EDRM-E assessment]
• BCW provider(s) Early Intervention Coordinator satisfaction with EDRM-E pilot survey [Срок оценки: 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 [Срок оценки: Through study completion, an average of 1 year]
• Number of families who received ASD evaluation by the end of the study through the pilot versus other means [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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. .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Emory University — Atlanta

Идентификаторы

NCT: NCT07623759 · 2026P000244

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗