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Идёт набор NCT05419895

Early Diagnostic Response Model (EDRM)

Без фазы С лечением Autism Spectrum Disorder Autism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Early Diagnostic Response Model (EDRM).
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder, Autism. Базовые параметры: 16 мес. — 36 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in Early Intervention Health Districts

Обзор

Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.

Подробное описание

The objective of this study is to develop, pilot, and evaluate a diagnostic protocol to assess high-risk toddlers for autism spectrum disorder (ASD) diagnosis of families enrolled in the Georgia Babies Can't Wait (BCW) early intervention program. The Early Diagnostic Response Model (EDRM) project will be addressing children who are identified at high risk for ASD according to the BCW screening protocol, which is the M-CHAT-R/F. Community psychologist will be taught the protocol and receive referrals to build capacity and better address the need across the state. Currently, many children who are screening high-risk for ASD in BCW districts are unable to access follow-up evaluations due to limited community resources and long wait times. It is hypothesized that the EDRM will be successful in increasing the number of BCW families that access an ASD evaluation using telehealth tools and testing protocols and that the families and clinicians involved will be satisfied with the streamlined process. The clinicians' conclusions from the EDRM assessment will be based on the Diagnostic and Statistical Manual, 5th edition (DSM-5; American Psychiatric Association \[APA\], 2013) and are hypothesized to be able to provide high-risk children and their families with the same access to services as an in-person assessment.

A secondary objective is to investigate how many high-risk referral assessments can be completed entirely via streamlined telehealth protocol and how many required additional information to be collected to make a final DSM-5 conclusion.

A tertiary objective is to investigate the improvement of the EDRM as an early identification model to assess for ASD by comparing the numbers of families screened high risk for ASD and referred for an evaluation prior to the study to the number of families who received ASD evaluation by the end of the study through the pilot versus other means. These numbers will be analyzed globally as well as by specific BCW district and other child factors.

Вмешательства

  • Поведенческое Early Diagnostic Response Model (EDRM)
    Use of telehealth capabilities to implement measures and capture and code information related to an autism diagnosis. This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.

Первичные конечные точки

  • Number of participants referred to the Early Diagnostic Response Model (EDRM) [Срок оценки: Until the end of the study (approximately one year)]
  • Number of participants consented in the Early Diagnostic Response Model (EDRM) study [Срок оценки: Monthly until until the end of the study (approximately one year)]
  • Response rate in the Early Diagnostic Response Model (EDRM) study [Срок оценки: Until end of the study (approximately one year)]
  • Number of participants that completed the Early Diagnostic Response Model (EDRM) 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 (11)
  • Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol [Срок оценки: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention]
  • Number of of high-risk referral by BCW district [Срок оценки: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention]
  • Number of of 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 of high-risk referral 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 assessment survey [Срок оценки: At completion of EDRM assessment (4 weeks post-intervention)]
  • BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey [Срок оценки: At completion of EDRM assessment (4 weeks post-intervention)]
  • Parent satisfaction with access to treatment survey [Срок оценки: 3 months after completion of EDRM assessment]
  • BCW provider(s) Early Intervention Coordinator satisfaction with EDRM pilot survey [Срок оценки: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention]
  • Number of families screened 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

  • All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.
  • Referring BCW provider must be one of the participating BCW health districts in this pilot study.
  • Parent/Guardian needs to have basic English proficiency
  • Parent/Guardian needs to have internet access
  • Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).
  • Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.

Критерии исключения

  • Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.
  • Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.
  • Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.

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 Autism Center — Atlanta

Идентификаторы

NCT: NCT05419895 · STUDY00003763

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗