Меню
Идёт набор NCT05078970

Advancing Suicide Intervention Strategies for Teens During High Risk Periods

Без фазы С лечением Suicide Attempts Suicidal Ideation Suicide and Self-harm Suicide Threat

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: Safety Planning Intervention+ (SPI+), Collaborative Assessment and Management of Suicidality (CAMS), Treatment As Usual.
Кому может быть актуально
Состояния в реестре: Suicide Attempts, Suicidal Ideation, Suicide and Self-harm, Suicide Threat. Базовые параметры: 11 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

To inform the effective management of adolescent suicide risk by evaluating promising treatments and developing the evidence-base for interventions that are well suited for widespread adoption, sustained quality, and impact.

Подробное описание

The current study aims to evaluate Safety Planning Intervention with follow-up (SPI+), Collaborative Assessment and Management of Suicidality (CAMS) and usual care. Adolescents, parents, and clinicians will participate in the project to advance to following Research Aims: 1) Assess the comparative effectiveness of CAMS and SPI+ compared to usual care, 2) Evaluate the mechanism of change accounting for the therapeutic effects of the interventions 3) Identify moderators of treatment effects. Participants and their parents will receive study assessments at baseline, 2-week, 1-month, 2-month, 6-month, and 12-month timepoints. Study assessments will ask about participant demographics (sample characterization), suicide attempts, suicidal ideation, non-suicidal self-injury, service utilization, self-assessed risk, treatment integrity, sleep, family cohesion, and social experiences. Youth participants and their legal guardian both consent to participate in the research procedures.

Вмешательства

  • Поведенческое Safety Planning Intervention+ (SPI+)
    SPI is focused on how the risk of suicidal crisis waxes and wanes over time. At times of heightened risk, a pre-specified and individualized plan targets the internal warning signs that become the cue to use the safety plan. SPI+ strategies focus on patient's narrative of the suicidal crisis and identifying solutions that are antithetical to progressing in a suicidal crisis. The brief structured intervention is conducted in six key steps. Youth in this condition will be offered weekly follow-up,
  • Поведенческое Collaborative Assessment and Management of Suicidality (CAMS)
    CAMS strategies focus on collaborative deconstruction and treatment of the patient-defined drivers- the problems that make suicide compelling to the patient- and utilizes these problem-focused treatment sessions to treat the drivers as directly related to wish to die. Participants will be assigned to CAMS for a minimum of 4 sessions and maximum of eight sessions. This time frame, based on initial data from our pilot work with adolescents and emerging adults (18-25), suggests that a subset of par
  • Поведенческое Treatment As Usual
    This assigned condition tracks the care received in typical circumstances.

Первичные конечные точки

  • Suicidal events [Срок оценки: Suicidal events at 12 months]
Вторичные конечные точки (2)
  • Suicide attempts [Срок оценки: Suicide attempts at 12 months]
  • Suicidal Ideation [Срок оценки: Change in score from baseline to 12 months]

Критерии участия

Критерии включения

  • Provision of signed and dated informed consent form
  • Youth, aged 11-17
  • Endorse suicidal ideation and/or behavior
  • Admitted to acute care (emergency, inpatient medical or inpatient psychiatric) due to suicidality

Критерии исключения

  • Presence of psychosis, intellectual disability, autism spectrum disorder, eating disorder with unstable vitals
  • Limited English proficiency that would interfere with the ability to complete study assessments

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Nationwide Children's — Columbus
  • Seattle Children's — Seattle

Публикации

  • Adrian M, McCauley E, Gallop R, Stevens J, Jobes DA, Crumlish J, Stanley B, Brown GK, Green KL, Hughes JL, Bridge JA. Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial. BMJ Open. 2023 Dec 12;13(12):e074116. doi: 10.1136/bmjopen-2023-074116. PMID 38086585

Идентификаторы

NCT: NCT05078970 · 1R01MH123442

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗