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Идёт набор NCT05920252

A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide

Без фазы С лечением Suicide Mental Health Disorder Anhedonia

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: Vira, Treatment as Usual (TAU).
Кому может быть актуально
Состояния в реестре: Suicide, Mental Health Disorder, Anhedonia. Базовые параметры: 13 лет — 18 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 →

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Официальное название

Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide

Обзор

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.

Подробное описание

Suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people. Specifically, it will conduct a pragmatic randomized controlled trial (RCT) based at the intensive outpatient services (Intensive Adolescent and Family DBT Program (Columbia Doctors)) to test the impact of using the Vira platform for patients versus treatment as usual control (TAU; i.e., not using Vira). This project will include adolescent patients (n = 200) aged 13-18-years-old randomized to: (a) Vira group (n = 100) and (b) treatment as usual control group (n = 100). Participants will include current patients receiving treatment in the intensive outpatient program, and all treatment decisions will be overseen by practitioners within the program. The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes.

Вмешательства

  • Поведенческое Vira
    Intensive outpatient DBT supported by the Vira platform. The Vira app is installed on the patient's smartphone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of
  • Поведенческое Treatment as Usual (TAU)
    Intensive outpatient DBT + EARS app (passive data monitoring software)

Первичные конечные точки

  • Columbia Suicide Severity Rating Scale (C-SSRS) [Срок оценки: 6 months]
  • Scale for Suicidal Ideation (SSI) [Срок оценки: 6 months]
Вторичные конечные точки (5)
  • Screen for Anxiety Related Emotional Disorders (SCARED) [Срок оценки: 3 and 6 months]
  • Risky Behavior Questionnaire for Adolescents (RBQ-A) [Срок оценки: 3 and 6 months]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 3 and 6 months]
  • Mood and Feelings Questionnaire (MFQ) [Срок оценки: 3 and 6 months]
  • Anticipatory & Consummatory Interpersonal Pleasure Scale (ACIPS) [Срок оценки: 3 and 6 months]

Критерии участия

Критерии включения

  • Written informed assent from adolescents ages 13-17 years old and permission from legal guardians, or consent from adolescents age 18 years old.
  • Receiving treatment at the Intensive Adolescent and Family DBT Pgogram
  • 13-18 years old
  • Owns a personal smartphone (Android or iPhone 7+)
  • Fluent in English

Критерии исключения

  • Adolescents who require a higher level of care (i.e., are not admitted to the Intensive Outpatient DBT program)
  • Adolescents who are receiving treatment at the Intensive Adolescent and Family DBT program and have already been assigned a clinician

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Columbia University — New York

Идентификаторы

NCT: NCT05920252 · OV-002 · R44MH128484 · AAAV0626

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗