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Предотвращение суицидального поведения среди молодежи из группы высокого риска в отделениях неотложной помощи (Project HOPE)

2 ноября 2026 г. обновлено: Johns Hopkins University

This multisite randomized controlled trial will compare two brief interventions for youth and young adults ages 12-24 following an acute care visit for suicide risk: the Stanley-Brown Safety Planning Intervention with follow-up contacts (SPI+) and Interpersonal Psychotherapy for Adolescents-Ultra Short Crisis Intervention (IPT-A SCI). The study will evaluate which approach is more effective in reducing suicidal ideation and suicide events. Findings will help patients, families, and clinicians make informed decisions about care following a suicide-related emergency department visit.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

Youth and young adults who present to emergency departments (EDs) with suicide-related concerns need timely access to effective interventions and follow-up care. However, evidence is limited regarding which brief interventions are most effective for this population. This study focuses on youth and young adults ages 12-24 receiving care in five racially and ethnically diverse geographic areas: Philadelphia, Pennsylvania; Baltimore, Maryland; Chapel Hill, North Carolina; St. Petersburg, Florida; and New York City, New York.

This multisite randomized controlled trial compares two brief interventions: the Safety Planning Intervention with follow-up contacts (SPI+) and Interpersonal Psychotherapy for Adolescents-Ultra Short Crisis Intervention (IPT-A SCI). SPI+ is a suicide-specific intervention that helps participants recognize warning signs and identify coping strategies and sources of support to prevent suicidal crises from escalating. It combines safety planning in the acute care setting with follow-up contacts. IPT-A SCI is a brief psychotherapy intervention delivered primarily in outpatient settings that addresses interpersonal problems associated with suicidal crises and helps participants develop communication and interpersonal problem-solving skills.

The study will examine the comparative effectiveness of these interventions in reducing suicidal ideation and suicide events among youth and young adults following an acute care visit for suicide risk. Although both approaches are intended to support participants during periods of elevated risk, the approaches differ in focus, intensity, and delivery setting. Understanding comparative effectiveness can help guide treatment decisions, implementation, and resource allocation across acute care and outpatient settings.

The research team works with a racially and ethnically diverse group of partners and advisors, including advocates, researchers, ED physicians, nurses, social workers, and individuals with lived experience of suicide attempts or suicide loss. Partners and advisors have contributed to recruitment strategies, intervention approaches, and follow-up procedures and will continue to inform study conduct, interpretation of findings, and dissemination.

Findings from this study will help inform care for youth and young adults presenting to EDs with suicide-related concerns and support the implementation of effective, brief interventions across diverse clinical settings.

Тип исследования

Интервенционный

Регистрация (Оцененный)

484

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Holly C Wilcox, PhD
  • Номер телефона: 410-370-0081
  • Электронная почта: hwilcox1@jhmi.edu

Учебное резервное копирование контактов

  • Имя: Catherine Grela
  • Номер телефона: 667-217-4303
  • Электронная почта: agrelam1@jh.edu

Места учебы

  • Соединенные Штаты
    • Florida
      • St. Petersburg, Florida, Соединенные Штаты, 33701
        • Рекрутинг
        • Johns Hopkins All Children's Hospital
        • Контакт:
          • Jennifer Katzenstein, PhD
          • Номер телефона: 727-767-7439
          • Электронная почта: jkatzen7@jhmi.edu
        • Контакт:
          • Jasmine Niazi, M.S.
          • Номер телефона: 727-767-2389
          • Электронная почта: jniazi1@jh.edu
        • Главный следователь:
          • Jennifer Katzenstein, PhD
    • Maryland
      • Baltimore, Maryland, Соединенные Штаты, 21205
        • Рекрутинг
        • Johns Hopkins University
        • Контакт:
          • Holly C. Wilcox, PhD
          • Номер телефона: 410-370-0081
          • Электронная почта: hwilcox1@jhmi.edu
        • Главный следователь:
          • Holly C Wilcox, PhD
        • Контакт:
          • Catherine Grela
          • Номер телефона: 667-217-4303
          • Электронная почта: agrelam1@jh.edu
    • New York
      • New York, New York, Соединенные Штаты, 10032
        • Рекрутинг
        • Columbia University Irving Medical Center (CUMC)
        • Контакт:
          • Laura Mufson, PhD
          • Номер телефона: 646-774-5791
          • Электронная почта: Lhm3@cumc.columbia.edu
        • Контакт:
        • Главный следователь:
          • Laura Mufson, PhD
        • Младший исследователь:
          • Christa Labouliere, PhD
      • New York, New York, Соединенные Штаты, 10065
        • Рекрутинг
        • Weill-Cornell Medicine
        • Контакт:
          • Shannon Bennett, PhD
          • Номер телефона: 646-962-2820
          • Электронная почта: smb9017@med.cornell.edu
        • Контакт:
          • Gail Harrison
          • Номер телефона: 929-646-0627
          • Электронная почта: gah4007@med.cornell.edu
        • Главный следователь:
          • Shannon Bennett, PhD
    • North Carolina
      • Chapel Hill, North Carolina, Соединенные Штаты, 27514
        • Рекрутинг
        • University of North Carolina Medical Center
        • Контакт:
          • Danielle Lowe, MD, PhD
          • Номер телефона: 919-445-0870
          • Электронная почта: Danielle_Lowe@med.unc.edu
        • Контакт:
          • Rachel Ear, PhD
          • Номер телефона: 919-445-0870
          • Электронная почта: earr@unc.edu
        • Главный следователь:
          • Danielle Lowe, MD, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19104
        • Рекрутинг
        • Childrens Hospital of Philadelphia
        • Контакт:
          • Tami Benton, MD
          • Номер телефона: 609-351-2637
          • Электронная почта: bentont@chop.edu
        • Контакт:
        • Главный следователь:
          • Tami Benton, PhD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 12 лет до 24 года (Ребенок, Взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Suicide Risk During Acute Care Visit (At least one item must apply: Chief complaint of suicide-related concern, Active suicidal ideation endorsed in past 1 month on validated suicide screener, Suicidal behavior in the past 3 months on validated suicide screener, and/or Clinician indicated SI in past month or SA in past 3 months).
  • Have access to a cellular phone with the ability to receive phone calls and text messages over the 12-month follow- up period
  • Adolescent must be verbally fluent and can communicate, understand, and read in either English or Spanish
  • Adolescent has been/will be discharged from a higher level of care (i.e. inpatient, day hospital, partial hospitalization program (PHP), or residential treatment program) and back in the community within 4 weeks of the acute care visit.

Exclusion Criteria:

  • Significant cognitive or developmental delays that prevent understanding or using SPI+ or IPT-A-SCI (includes inability to communicate verbally)
  • Altered mental status (acute psychosis, intoxication, or mania)
  • Unable or unwilling to provide informed consent (adults), assent (minors), or permission (parents/caregivers)
  • The services offered through the study are not in the best clinical interest of the patient (e.g., presenting problem requires a different level of care or treatment approach).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Safety Planning Intervention (SPI)

The SPI is a brief, evidence- based intervention that provides people with an individualized set of steps that can be used progressively to both reduce risk and maintain safety when suicide ideation (SI) emerges. Safety plans are developed collaboratively between providers, at risk youth, and family members when possible. Core SPI components include recognizing warning signs of an imminent suicidal crisis (e.g., changes in mood, thoughts or behaviors); using internal coping skills to reduce distress; using people or places in the individual's support network as a means of distraction from SI; reaching out to family or friends to help manage the crisis; contacting health professionals or emergency services; and reducing access to lethal means. SPI+ includes a brief follow-up component post- discharge that includes contacting the patient for a mood and risk check-in; reviewing and revising the safety plan; and facilitating connection with community mental health services.
Поведенческий: Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+)

Stanley Brown Safety Planning completed in the emergency department with 3 follow-up contacts after discharge
Активный компаратор: Ultra-Brief Crisis Interpersonal Psychotherapy for Suicidal Children and Adolescents (IPT-A-SCI)

Ultra-Brief Crisis Interpersonal Psychotherapy for Suicidal Children and Adolescents (IPT-A-SCI) is a scalable, flexible, and extensively examined mental health treatment developed to reduce depressive symptoms and improve interpersonal functioning, and has been adapted for use in adolescents (IPT-A-SCI) and shown to be effective in treating depression and reducing associated suicide risk. Interpersonal problems are often at the core of suicidal thinking and behavior in youths including minority youths.
Поведенческий: Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)

Five session crisis focused version of IPT for adolescents.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Suicidal ideation as assessed by the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent
Временное ограничение: baseline, 3 months, 6 months, 12 months

Suicidal thoughts: measured using the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent. Scores for suicidal ideation range from 0 to 5, with higher scores indicating more serious suicidal ideation, where 0 = "no suicidal thoughts"; 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan".
baseline, 3 months, 6 months, 12 months
Suicide events: measured using the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Service Assessment for Children and Adolescents (SACA) Recent
Временное ограничение: baseline, 3 months, 6 months, 12 months

Suicide event is defined as the presence of a suicide attempt, an aborted or interrupted attempt (as identified on the C-SSRS), or a visit to the emergency department, crisis stabilization acute care facility, or psychiatric hospitalization for suicide-related concerns (as identified on the SACA) occurring anytime during the follow-up period.
baseline, 3 months, 6 months, 12 months
Number of Suicides
Временное ограничение: 12 months

Measured through Death Records or Suicide from Office of Chief Medical Examiner, family report or medical record
12 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)
Временное ограничение: baseline, 3 months, 6 months, 12 months

Services Assessment for Children and Adolescents (SACA) use of inpatient, outpatient, school services since last assessment. Items are dichotomous (yes/no) and the scale ranges from 0 (no services) to 3 (3 types of services), higher numbers indicate more services.
baseline, 3 months, 6 months, 12 months
Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L)
Временное ограничение: baseline, 3 months, 6 months, 12 months

Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L) for young adults. The scale consists of a descriptive system that comprises five items referring to the domains mobility, self-care, usual activities, pain/discomfort and anxiety/depression scored as presenting no problems, moderate problems or severe problems. Each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0 (the worst) -100 (the best health state imaginable).
baseline, 3 months, 6 months, 12 months
Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y)
Временное ограничение: baseline, 3 months, 6 months, 12 months

Quality of Life will be assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y). The scale consists of a descriptive system that comprises five items referring to the domains mobility, self-care, usual activities, pain/discomfort and anxiety/depression scored as presenting no problems, moderate problems or severe problems. Each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0 (the worst) -100 (the best health state imaginable).
baseline, 3 months, 6 months, 12 months
Change in Generalized Anxiety Disorder as assessed by the The Generalized Anxiety Disorder 7 question scale (GAD-7).
Временное ограничение: baseline, 3 months, 6 months, 12 months

Generalized Anxiety Disorder will be assessed by the GAD 7 question scale. The Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. The GAD-7 total score ranges from 0 to 21 with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).
baseline, 3 months, 6 months, 12 months
Change in Depression severity as assessed by the nine-item Patient Health Questionnaire (PHQ-9).
Временное ограничение: baseline, 3 months, 6 months, 12 months

The nine-item Patient Health Questionnaire is a depressive symptom scale and diagnostic tool that assesses the presence and severity of depressive symptoms and a possible depressive disorder. The PHQ-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
baseline, 3 months, 6 months, 12 months
Change in conflicts with family members as assessed by the Conflict Behavior Questionnaire (CBQ).
Временное ограничение: baseline, 3 months, 6 months, 12 months

The Conflict Behavior Questionnaire (CBQ) reliably assesses the adolescent's perception of the relationship with the participant's parents. The CBQ total score ranges from 0-20, with higher scores indicating greater conflict with each parent.
baseline, 3 months, 6 months, 12 months
Change in social interactions with peers as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Peer Relationships scale.
Временное ограничение: baseline, 3 months, 6 months, 12 months

The PROMIS (Patient-Reported Outcomes Measurement Information System) scale assesses social interactions with peers. The Pediatric Peer Relationships scale has a possible score between 1 and 40, with higher scores indicating greater social interactions with peers.
baseline, 3 months, 6 months, 12 months
Change in social interactions with family as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Family Relationships scale.
Временное ограничение: baseline, 3 months, 6 months, 12 months

The Patient-Reported Outcomes Measurement Information System (PROMIS) scale assesses social interactions with family. The Pediatric Family Relationships scale has a possible score between 1 and 40, with higher scores indicating greater social interactions with family.
baseline, 3 months, 6 months, 12 months
Change in skill use derived from the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) arm
Временное ограничение: 3 months, 6 months, 12 months

Project-created a self-report of Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) skill use during follow-up, indicating feasibility/acceptability of SPI, helpfulness of different skills/sections of the safety plan, and frequency of use for different skills/sections of the safety plan.
3 months, 6 months, 12 months
Change in skill use derived from the Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) arm
Временное ограничение: 3 months, 6 months, 12 months

Project created a self-report of Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) skill use during follow-up indicating which components adolescents have used. The self-report survey scoring will be a summation and then taking an average of the sum to be the score. Higher scores closer to 5 indicate adolescents learned a lot of from the intervention, and the lower scores indicate adolescents learned few skills.
3 months, 6 months, 12 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Johns Hopkins University

Соавторы

Patient-Centered Outcomes Research Institute
Children's Hospital of Philadelphia
Columbia University
Johns Hopkins All Children's Hospital
Reichman University

Следователи

  • Главный следователь: Holly C Wilcox, PhD, Johns Hopkins Bloomberg School of Public Health

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

15 марта 2025 г.

Первичное завершение (Оцененный)

15 июня 2028 г.

Завершение исследования (Оцененный)

15 июля 2029 г.

Даты регистрации исследования

Первый отправленный

21 ноября 2023 г.

Впервые представлено, что соответствует критериям контроля качества

21 ноября 2023 г.

Первый опубликованный (Действительный)

30 ноября 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

4 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • IRB00408733

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

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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