- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07628192
Youth Suicide Prevention: CAMS-BI vs. Safety Planning in a Randomized Trial
Innovating Suicide Preventative Care for Youth; A Randomized Trial of CAMS- BI Versus Stanley- Brown Safety Planning Intervention in Preventing Suicide Driven Readmission
This study outlines a randomized controlled trial evaluating two brief suicide-specific interventions for adolescents aged 12-17 who are hospitalized for suicidal ideation or attempts. Suicide remains a leading cause of death among youth, and many adolescents are discharged from inpatient care without targeted, suicide-focused treatment, contributing to high rates of readmission and ongoing risk. This study seeks to address that gap by comparing the effectiveness of the Collaborative Assessment and Management of Suicidality-Brief Intervention (CAMS-BI) with the Stanley-Brown Safety Planning Intervention (SPI), both delivered as single-session interventions during inpatient hospitalization.
Participants (N=118) will be randomly assigned to receive either CAMS-BI or SPI. CAMS-BI is a therapeutic, collaborative framework that focuses on identifying and addressing the underlying psychological drivers of suicidality, while SPI is a structured, practical approach that emphasizes immediate safety through coping strategies, support systems, and means restriction. Following the intervention, participants will be monitored for 90 days post-discharge, with follow-ups at 30, 60, and 90 days.
The primary outcome is the rate of psychiatric readmissions and suicide-related emergency department visits within 90 days of discharge. Secondary outcomes include changes in suicidal ideation, measured by the Beck Scale for Suicide Ideation, and caregiver confidence in managing their child's safety. Additional measures include distress levels, hopelessness, treatment satisfaction, and engagement.
The study hypothesizes that CAMS-BI will result in lower readmission rates, greater reductions in suicidal ideation, and improved caregiver confidence compared to SPI. Both interventions produce individualized safety or stabilization plans that are shared with patients and caregivers and incorporated into discharge planning to support continuity of care.
Safety protocols are emphasized throughout the study, given the high-risk population. Participants receive standard clinical care, crisis resources, and close monitoring, with procedures in place to address any escalation in suicide risk. Data will be collected using secure systems, and confidentiality will be maintained through de-identification and controlled access.
Overall, this study aims to determine whether a rapid, inpatient, suicide-focused intervention can improve short-term outcomes for high-risk youth and reduce the likelihood of rehospitalization, ultimately informing scalable approaches to suicide prevention in clinical settings.
Обзор исследования
Статус
Условия
Подробное описание
This single-site randomized controlled trial evaluates two brief suicide-specific interventions for adolescents hospitalized for suicidal ideation or suicide attempts at Cleveland Clinic Children's. The study compares the Collaborative Assessment and Management of Suicidality-Brief Intervention (CAMS-BI) with the Stanley-Brown Safety Planning Intervention (SPI) to determine their effectiveness in reducing suicide-related psychiatric readmissions and emergency department utilization following inpatient psychiatric hospitalization.
Adolescent suicide remains a major public health concern and is one of the leading causes of death among youth ages 10-24 years. Psychiatric hospitalization provides an important opportunity to intervene following suicidal crises; however, many adolescents are discharged without receiving a structured suicide-focused therapeutic intervention beyond standard stabilization and discharge planning. Brief, scalable interventions that can be delivered during hospitalization may improve continuity of care and reduce recurrent suicidal crises after discharge.
Participants are adolescents ages 12-17 years admitted for suicidal ideation or suicide attempts. Eligible participants are randomized in a 1:1 ratio to receive either CAMS-BI or SPI during their inpatient admission. Randomization is stratified by gender and implemented using REDCap block randomization procedures.
CAMS-BI is a collaborative, suicide-focused therapeutic intervention adapted from the Collaborative Assessment and Management of Suicidality framework. The intervention uses the Suicide Status Form (SSF) to identify and target the psychological drivers of suicidality, including hopelessness, psychological pain, agitation, and self-hate. Sessions emphasize collaborative assessment, treatment planning, and therapeutic alliance.
SPI is a structured suicide prevention intervention focused on developing an individualized safety plan to support crisis management after discharge. The intervention includes identification of warning signs, coping strategies, supportive contacts, professional resources, and means restriction planning.
Participants complete study assessments at baseline, following the intervention, and during follow-up at 30, 60, and 90 days after discharge. Clinical outcomes include psychiatric readmissions, suicide-related emergency department visits, suicidal ideation severity, distress, hopelessness, caregiver confidence in crisis management, and participant satisfaction with the intervention.
Intervention fidelity is monitored through clinician training, structured supervision, and review of recorded intervention sessions using standardized fidelity measures specific to each intervention.
All participants continue to receive standard inpatient psychiatric treatment and discharge planning throughout study participation. Safety monitoring procedures are in place for escalation of suicide risk, including access to crisis intervention resources and clinical evaluation as needed. Study data are maintained in secure HIPAA-compliant systems.
The study is designed to determine whether a brief suicide-focused therapeutic intervention targeting the underlying drivers of suicidality provides additional benefit compared with structured safety planning alone in reducing short-term suicide-related outcomes among high-risk adolescents.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Tatiana Falcone, M.D.
- Номер телефона: (216) 444-7459
- Электронная почта: falcont1@ccf.org
Учебное резервное копирование контактов
- Имя: Christina A Deisz, LISW-S
- Номер телефона: (440) 225-6193
- Электронная почта: deiszc@ccf.org
Места учебы
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Ohio
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Cleveland, Ohio, Соединенные Штаты, 44195
- The Cleveland Clinic
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Контакт:
- Tatiana Falcone, M.D.
- Номер телефона: (216) 444-7459
- Электронная почта: falcont1@ccf.org
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Adolescents aged 12-17 years.
- Admitted to inpatient psychiatry for suicide attempt or active suicidal ideation.
- English-speaking patient and parent/guardian.
- Ability to understand and the willingness to sign a written informed assent document with a parent/guardian willing and able to sign a written informed consent.
Exclusion Criteria:
- Moderate or severe intellectual disability (IQ less than 70 and those patients in special education classes full time).
- Schizophrenia or history of any type of psychosis including mood related psychosis and brief reactive psychosis.
- In custody of Children's Services.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: CAMS-BI
Participants randomized to receive CAMS-BI intervention
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CAMS-BI is a brief, structured, suicide-focused psychotherapy delivered during inpatient hospitalization that uses the Suicide Status Form to collaboratively identify and directly target the patient's specific psychological drivers of suicidality (e.g., hopelessness, psychological pain, agitation, and self-hate).
It emphasizes a strong therapeutic alliance and shared formulation to reduce suicidal risk and support linkage to ongoing care after discharge.
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Активный компаратор: Stanley Brown
Participants randomized to Stanley Brown Safety Plan
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The Stanley-Brown Safety Planning Intervention (SPI) is a brief, structured, collaborative session in which the adolescent and clinician create a personalized written safety plan to use during future suicidal crises.
The plan outlines warning signs, internal coping strategies, social supports, professional resources, and steps for restricting access to lethal means to help reduce immediate risk.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Reduction of inpatient psychiatry readmissions for suicide risk following CAMS-Brief Intervention VS Stanley-Brown Planning Intervention
Временное ограничение: 90 days following discharge
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To compare CAMS-Brief Intervention VS Stanley-Brown Planning Intervention in reducing psychiatric readmissions and suicide-related emergency department (ED) visits within 90 days after discharge.
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90 days following discharge
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Intensity of the Beck Scale for Suicide Ideation
Временное ограничение: 90 days after discharge
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To compare interventions' effects on suicidal ideation intensity using the Beck Scale for Suicide Ideation (min 0, max 38)(higher scoring = more severe).
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90 days after discharge
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Improving caregiver confidence pre and post intervention using a 'Caregiver Confidence' 2 question scale
Временное ограничение: 90 days post discharge
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To assess changes in caregiver confidence pre- and post-intervention in supporting suicidal youth and maintaining home safety using a 2 question scale.
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90 days post discharge
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Tatiana Falcone, M.D., The Cleveland Clinic
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB 26-129
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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