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Brief Crisis Therapy for Suicidal Children and Adolescents (IPT-A-SCI)

8 июня 2026 г. обновлено: Chamutal Saragusty, Tel Aviv University

Ultra-Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI): Understanding Mechanisms of Change

The goal of this clinical trial is to learn if the Ultra-Brief Interpersonal Psychotherapy for Adolescents with Suicidal Ideation (IPT-A-SCI) works to reduce suicidal thoughts and behaviors in children and adolescents. The study will also examine whether treatment effects continue after treatment ends and whether some participants benefit more from the intervention than others. The main questions it aims to answer are:

Does IPT-A-SCI reduce suicidal thoughts and behaviors in children and adolescents? Do the effects of IPT-A-SCI continue three months after treatment ends? Do some children and adolescents benefit more from IPT-A-SCI than others?

Participants will:

Receive IPT-A-SCI treatment consisting of five weekly sessions Complete questionnaires before treatment, during treatment, at the end of treatment, and three months after treatment ends Have their parents complete questionnaires at the same time points

Обзор исследования

Статус

Еще не набирают

Вмешательство/лечение

Подробное описание

IPT-A-SCI (Ultra-Brief Crisis Interpersonal Psychotherapy for Adolescents with Suicidal Ideation) is a manualized five-session crisis intervention based on Interpersonal Psychotherapy (IPT) principles.

IPT-A-SCI is designed for children and adolescents aged 8-18 presenting with suicidal ideation or behavior. The intervention combines IPT principles with the Safety Planning Intervention and includes a three-month post-intervention contact protocol.

This is a single-group, pre-post interventional study with repeated measures collected at four time points. All participants will receive the IPT-A-SCI intervention. There is no control or comparison group in this study, as the research focuses on within-person mechanisms of change and moderators of treatment response rather than between-group comparisons.

Participants will be recruited from the Child and Adolescent Clinic at Geha Mental Health Center through emergency room referrals, outpatient providers, and treating therapists at the clinic. Initial evaluation and suicide risk assessment will be conducted by experienced clinical staff according to established clinical guidelines for suicide risk assessment in adolescents.

Up to 120 participants will be enrolled over an estimated two-year recruitment period.

During the three months following treatment, participants will receive three personalized emails at 2 weeks, 1 month, and 2 months post-treatment. A follow-up session will take place three months after treatment completion. Psychiatric or psychosocial treatment may continue as usual during IPT-A-SCI.

Statistical Analysis Plan:

Three complementary analytic frameworks will be used:

  1. Modeling within-person change across therapy
  2. Examining associations between changes in proposed mechanisms of change and changes in suicidality
  3. Identifying participant characteristics associated with differential treatment response Individual Growth Curve Modeling (IGCM) will be used to examine trajectories of change across the four assessment time points for proposed mechanisms of change, including hope, perceived social support, emotional processing, family conflict, and interpersonal functioning.

Latent Change Score (LCS) modeling will be used to assess changes in suicidal ideation and related clinical outcomes from baseline to post-treatment and follow-up. Associations between changes in proposed mechanisms and changes in suicidality will be examined to identify factors that may contribute to treatment effectiveness.

Linear Mixed-Effects Models (LMMs) will be used to examine whether treatment effectiveness varies according to baseline participant characteristics, including initial suicide risk severity and other demographic and clinical variables. These analyses will identify moderators of treatment response and determine which participants derive the greatest benefit from the intervention.

Missing data will be handled in accordance with established best practices for longitudinal clinical research. The analytic approaches described above accommodate missing data under missing-at-random assumptions.

Data Collection and Management:

  • Questionnaires will be completed by participants and parents at all assessment time points.
  • The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered by clinicians during treatment sessions.
  • A unique trial identification number will be assigned at recruitment and used across all study materials.
  • All study data will be retained in accordance with Good Clinical Practice (GCP) guidelines.

Safety Monitoring and Ethical Considerations:

This study focuses on children and adolescents at risk for suicide. The Child and Adolescent Clinic at Geha Mental Health Center is located on the grounds of a psychiatric hospital with a 24/7 emergency room. Participants presenting with acute suicidal crisis during the study may be referred immediately for emergency psychiatric evaluation.

All treating clinicians are trained in suicide risk assessment and management. Adverse events, including worsening suicidal ideation or behavior, will be documented and reported in accordance with Helsinki Committee requirements and Good Clinical Practice guidelines.

No formal Data Safety Monitoring Board (DSMB) is in place for this study given its single-site naturalistic design. Clinical oversight will be provided through routine supervision and case conferencing.

Тип исследования

Интервенционный

Регистрация (Оцененный)

120

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: Chamutal Saragusty, MA
  • Номер телефона: 972-52-3400936
  • Электронная почта: yanivchamutal@gmail.com

Места учебы

      • Petah Tikva, Израиль
        • Geha Mental Health Center
        • Контакт:
          • Chamutal Saragusty, MA
          • Номер телефона: 972-52-3400936
          • Электронная почта: yanivchamutal@gmail.com
        • Главный следователь:
          • Chamutal Saragusty, MA

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

  • Ребенок
  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • Children and adolescents aged 8-18 years presenting with suicidal ideation or behavior
  • Suicide risk assessment indicating suitability for outpatient treatment,
  • Fluency in Hebrew
  • Ability to attend five weekly treatment sessions
  • Written informed consent provided by parents or legal guardians
  • Written informed assent/consent provided by participants in accordance with age and local ethical regulations

Exclusion Criteria:

  • Acute medical or psychiatric condition requiring immediate inpatient treatment
  • Linguistic, developmental, neurological, or intellectual limitations that prevent understanding of the treatment protocol or study procedures
  • Inability to participate in outpatient psychotherapy

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: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: IPT-A-SCI
Participants will receive the IPT-A-SCI intervention consisting of five weekly sessions of ultra-brief interpersonal psychotherapy combined with safety planning for suicidal ideation and behavior.
Manualized ultra-brief interpersonal psychotherapy intervention combined with safety planning for children and adolescents with suicidal ideation or behavior.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Severity of Suicidal Ideation
Временное ограничение: Baseline to 3-month follow-up
Change in severity of suicidal ideation and behavior assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS assesses the severity of suicidal ideation and the occurrence of suicidal behaviors. The suicidal ideation severity score ranges from 1 to 5, with higher scores indicating greater severity of suicidal ideation.
Baseline to 3-month follow-up

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Intensity of Suicidal Ideation
Временное ограничение: Baseline to 3-month follow-up
Change in intensity of suicidal ideation assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) ideation intensity scale. The C-SSRS assesses the intensity of the most severe suicidal ideation endorsed by evaluating five dimensions: frequency, duration, controllability, deterrents, and reasons for ideation. Total scores range from 0 to 25, with a score of 0 assigned when no suicidal ideation is endorsed and scores from 2 to 25 indicating increasing intensity of suicidal ideation. Higher scores indicate more intense suicidal ideation and a worse outcome.
Baseline to 3-month follow-up
Change in Depressive Symptoms
Временное ограничение: Baseline to 3-month follow-up
Change in depressive symptoms assessed using the Short Mood and Feelings Questionnaire (SMFQ). Scores range from 0 to 26, with higher scores indicating greater depressive symptom severity and a worse outcome.
Baseline to 3-month follow-up
Change in Perceived Social Support
Временное ограничение: Baseline to 3-month follow-up
Change in perceived social support assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). Scores range from 12 to 84, with higher scores indicating greater perceived social support and a better outcome.
Baseline to 3-month follow-up
Change in Emotional Processing (Alexithymia)
Временное ограничение: Baseline to 3-month follow-up
Change in emotional processing and alexithymia assessed using the Toronto Alexithymia Scale (TAS-20). Scores range from 20 to 100, with higher scores indicating greater difficulty identifying and describing emotions (greater alexithymia) and a worse outcome.
Baseline to 3-month follow-up
Change in Hope
Временное ограничение: Baseline to 3-month follow-up
Change in hope assessed using the Children's Hope Scale (CHS). Scores range from 6 to 36, with higher scores indicating greater hopefulness and a better outcome.
Baseline to 3-month follow-up
Change in Family Conflict and Interpersonal Stress
Временное ограничение: Baseline to 3-month follow-up
Change in family conflict and interpersonal stress assessed using the Family Environment Scale (FES) conflict subscale. Scores range from 0 to 9, with higher scores indicating greater family conflict and a worse outcome.
Baseline to 3-month follow-up
Change in Irritability and Emotional Dysregulation
Временное ограничение: Baseline to 3-month follow-up
Change in irritability and emotional dysregulation assessed using the parent-report TIDES-13 questionnaire. Total scores range from 13 to 91, with higher scores indicating greater irritability and emotional dysregulation and a worse outcome.
Baseline to 3-month follow-up
Change in Interpersonal and Social Functioning
Временное ограничение: Baseline to 3-month follow-up
Change in interpersonal and social functioning assessed using EFORTS social routine measures. Scores range from 0 to 5. with higher scores indicating better social routine functioning and executive functioning in daily activities and therefore a better outcome.
Baseline to 3-month follow-up
Behavioral and Emotional Problems at Baseline
Временное ограничение: Baseline only
Behavioral and emotional problems assessed using the parent-report Child Behavior Checklist (CBCL). This measure will be used for descriptive and covariate analyses. Raw scores vary according to age and sex and are converted to standardized T-scores. Higher T-scores indicate greater emotional and behavioral problems and a worse outcome.
Baseline only

Соавторы и исследователи

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

Спонсор

Соавторы

Следователи

  • Главный следователь: Chamutal Saragusty, MA, Geha Mental Health Center and Tel Aviv University

Публикации и полезные ссылки

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

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 (Оцененный)

1 июня 2026 г.

Первичное завершение (Оцененный)

1 июня 2028 г.

Завершение исследования (Оцененный)

1 июня 2028 г.

Даты регистрации исследования

Первый отправленный

30 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

30 мая 2026 г.

Первый опубликованный (Действительный)

4 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

11 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

8 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

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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