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Идёт набор NCT06400810

Proximal Risk for Suicide in Adolescents

Наблюдательное Suicide Mental Health Issue

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: Analog Devices Inc..
Кому может быть актуально
Состояния в реестре: Suicide, Mental Health Issue. Базовые параметры: 13 лет — 17 лет · 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 →

Обзор

The central hypothesis is that biometric data can continuously monitor and allow for early identification/intervention of escalating suicidal symptoms. The rationale is that improved outpatient monitoring through wearable technology can create a more objective platform to provide the ability to identify a worsening condition and utilize patient-specific just-in-time therapeutics developed with mental health providers for suicidal adolescents.

Подробное описание

Suicide rates have exponentially increased, and it is now the 2nd leading cause of death in adolescence, accounting for over 1.2 million annual emergency department (ED) visits. After an ED visit or attempt, up to 20% of adolescents will have a second attempt within 12 months, and almost half will have a repeat ED visit. This proposal's overall objectives are to investigate physiologic parameters and biometric data from wearable technology that is temporally related to suicidal behavior and develop a personalized, predictive tool that can improve outpatient identification of adolescent patients with suicidality before a crisis develops requiring an ED visit. The central hypothesis is that biometric data can continuously monitor and allow for early identification/intervention of escalating suicidal symptoms. The rationale is that improved outpatient monitoring through wearable technology can create a more objective platform to provide the ability to identify a worsening condition and utilize patient-specific just-in-time therapeutics developed with mental health providers for suicidal adolescents. To attain the overall objectives, I will pursue the following specific aims: (i) To evaluate whether HRV, combined with patient-specific risk factors, can be used to detect dynamic changes in suicide severity among a prospective cohort of acutely suicidal adolescents, (ii) To utilize machine learning to determine whether there is a temporal relationship/signature in the raw PPG signal before or immediately after changes in suicide severity reporting combined with patient-specific risk factors to develop a prediction tool for suicidality risk. These aims will be accomplished in three years through a prospective observational study enrolling acutely suicidal adolescents in the ED and an inpatient psychiatric unit. Ultimately, such knowledge can offer unique opportunities for early detection, just-in-time interventions, and support over 1.2 million suicidal adolescents presenting to EDs nationally.

Вмешательства

  • Устройство Analog Devices Inc.
    Wearable wrist device that collects Photoplethysmography, accelerometer data among other parameters.

Первичные конечные точки

  • Heart rate variability and Suicidality [Срок оценки: Four times daily up to one week]
  • Heart rate variability and Suicidality [Срок оценки: Four times daily up to one week]

Критерии участия

Критерии включения

  • subjects aged 13-17 years
  • presenting to the ED or inpatient psychiatric unit with a chief complaint of acute suicidality or attempt.

Критерии исключения

  • acutely agitated patients per the treating physician
  • adolescents who are not medically cleared from a suicide attempt
  • no legally authorized representative available to provide consent
  • parental report of significant developmental delay or autism diagnosis
  • prisoners
  • non-English speaking.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • OHSU — Portland

Идентификаторы

NCT: NCT06400810 · STUDY00022262

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗