Идёт набор NCT05874466
SenseToKnow Autism Screening Device Validation Study
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Autism, Autism Spectrum Disorder. 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 →
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Официальное название
SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development
Обзор
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow device for the detection of autism spectrum disorder in children 16-36 months of age.
Подробное описание
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow device for the classification of autism spectrum disorder when administered by parents in a sample of patients 16-36 months of age. The trial design is a non-interventional cross-sectional study comparing the SenseToKnow device classification of autism spectrum disorder ("autism") versus non-autism with the patient's diagnostic status based on expert clinical diagnosis in a population of pediatric patients.
Первичные конечные точки
- Sensitivity of the SenseToKnow screening device based on a machine learning algorithm that combines SenseToKnow digital data with data from the SenseToKnow Caregiver survey for autism detection [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
- Specificity of the SenseToKnow screening device based on machine earning algorithm that combines SenseToKnow digital data with data from the SenseToKnow Caregiver survey for autism detection [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
Вторичные конечные точки (8)
- Positive Predictive Value of SenseToKnow screening device (based on a machine learning algorithm using the SenseToKnow digital data, combined with the SenseToKnow Caregiver Survey data) for autism detection in comparison to expert clinical diagnosis [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
- Negative Predictive Value of SenseToKnow screening device (based on a machine learning algorithm using the SenseToKnow digital data, combined with the SenseToKnow Caregiver Survey data) for autism detection in comparison to expert clinical diagnosis [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
- Receiver Operating Characteristic Curve and Area Under the Curve with respect to the accuracy of the SenseToKnow screening device (using the SenseToKnow digital data and SenseToKnow Caregiver survey data) for autism versus non-autism classification [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
- Sensitivity of SenseToKnow screening device based on a machine learning algorithm using only the SenseToKnow digital data for autism detection [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
- Specificity of SenseToKnow screening device based on a machine learning algorithm using only the SenseToKnow digital data for autism detection [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
- Positive Predictive Value of SenseToKnow screening device based on a machine learning algorithm using only the SenseToKnow digital data for autism detection in comparison to expert clinical diagnosis [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
- Negative Predictive Value of SenseToKnow screening device based on a machine learning algorithm using only the SenseToKnow digital data for autism detection in comparison to expert clinical diagnosis [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
- Receiver Operating Characteristic Curve and Area Under the Curve with respect to the accuracy of the SenseToKnow device using only the SenseToKnow digital data for autism versus non-autism classification [Срок оценки: Will be calculated based on data from Baseline/Timepoint 1]
Критерии участия
Критерии включения
- Duke Health pediatric patient at enrollment
- 16-<37 months of age at enrollment
- Parent/legal guardian speaks English or Spanish
- Parent/legal guardian understands and voluntarily provides informed consent
Критерии исключения
- Severe motor impairment that precludes study measure completion
- Known genetic disorders
- Severe hearing or visual impairment as determined on physical examination according to parent report
- Acute illnesses likely to prevent successful or valid data collection
- Uncontrolled epilepsy or seizure disorder
- History or presence of a clinically significant medical disease, or a mental state that could confound the study or be detrimental to the subject as determined by the investigator
- Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
- Receiving therapies that affect vision
- Parent/legal guardian and/or investigator believes that the child will be unable/unwilling to sit in the parent's lap to watch the app videos
- Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
- Participants who are otherwise judged as unable to comply with the protocol by the investigator
- Any other factor that the investigator feels would make the study measures invalid
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Duke University — Durham
Идентификаторы
NCT: NCT05874466 · Pro00111371 · 2P50HD093074