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Набор скоро начнётся NCT07430566

Trauma Exposure and Suicidal Behaviors in Adolescents Aged 11-17 Hospitalized in Child and Adolescent Psychiatry

Без фазы С лечением Suicidal Ideation and Behavior Psychiatric Hospitalization

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: Blood samples, genetic analysis, Questionnaires and scales.
Кому может быть актуально
Состояния в реестре: Suicidal Ideation and Behavior, Psychiatric Hospitalization. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

It is a comparative monocentric study with longitudinal follow-up at 6 months in adolescents aged between 11 years and 17 years inclusive admitted to complete hospitalization either for suicidal behaviors or for other psychiatric causes. The objective is to explore the experiences of hospitalized adolescents regarding hospitalization, as well as their perceptions of the factors involved in their remission and their experience of the traumatic event(s) if they have been exposed.

Подробное описание

Suicidal behaviors among adolescents are a major public health issue. Traumatic exposure (sexual abuse, violence, serious accidents) is a recognized risk factor for psychopathology and suicidality, but its precise links with suicide recurrence, comorbid psychopathology, and neurodevelopmental vulnerability remain little studied.

Hypotheses:

* Traumatic exposure is more common among suicidal adolescents than non-suicidal. * It is associated with an increased risk of recurrence within 6 months. * The neurodevelopmental load, irritability, PTSD and lack of resilience factors modulate this risk. * Specific inflammatory biological profiles could be associated with suicidality.

Originality and innovative aspects:

* Multidimensional approach: clinical, psychometric, biological and qualitative. * Constitution of a biobank for future analyses (inflammatory, genetic, epigenetic). * Inclusion of a qualitative component exploring the subjective experience of hospitalized adolescents. * Integrated analysis of risk, protective and biological factors to guide personalized prevention.

The main objective is to compare the frequency of traumatic exposure history evaluated with the validated questionnaire in French of the CPC version child, among adolescents aged between 11 years old and 17 years inclusive admitted to hospital, either for suicidal behaviors (suicide group), either for other psychiatric causes without a history of suicidal behavior (non-suicidal group).

Вмешательства

  • Биопрепарат Blood samples
    A blood test will be carried out during the inclusion visit, on site, with collection of the time of completion, the last food samples and tobacco consumption. A 2.5 mL Paxgene® tube for whole blood RNA and a 5 mL dry tube for serum will be collected.
  • Генная терапия genetic analysis
    If consent for genetic analyses is obtained, a 4.5 mL EDTA tube to collect native DNA will be taken during the blood test
  • Другое Questionnaires and scales
    * Child Posttraumatic Checklist (CPC) * Life Event Checklist (LEC-5) * Posttraumatic CheckList-5 * K-SADS * Affective Reactivity Index (ARI) * Child Youth Resilience Measure * Adverse Childhood Experiences International Questionnaire (ACE-IQ) * Metacognitions Questionnaire (MCQ-A) * Cognitive Emotion Regulation Questionnaire (CERQ) * Adolescent Dissociative Experience Scale (A-DES) * Behavioral Rating Inventory of Executive Function Self-Report (BRIEF-2)

Первичные конечные точки

  • CPC Questionnaire child version [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • CPC questionnaire parents version [Срок оценки: Baseline]
  • Questionnaire Life Event Checklist (LEC-5) [Срок оценки: Baseline]
  • Schedule for Affective Disorders and Schizophrenia for school-age children (KSADS) full-life version [Срок оценки: Baseline]
  • Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline]
  • Affective Reactivity Index (ARI) [Срок оценки: Baseline]
  • Child Youth Resilience Measure (CYRM) [Срок оценки: Baseline]
  • Adverse Childhood Experiences International Questionnaire (ACE-IQ) [Срок оценки: Baseline]
  • CER-Q [Срок оценки: Baseline]
  • BRIEF-2 [Срок оценки: Baseline]
  • Meta-Cognitions Questionnaire for Adolescents (MCQ-A) [Срок оценки: Baseline]
  • DES-A [Срок оценки: Baseline]
  • Neurodevelopmental score [Срок оценки: Baseline]

Критерии участия

Common Inclusion Criteria:

  • Age between 11 and 17 years inclusive
  • Admitted for full-time psychiatric hospitalization
  • Obtaining consent from at least one of the adolescent's legal representatives and the adolescent's personal assent

Inclusion Criteria - "Suicidal Group":

\- Reason for admission: suicidal behavior (suicide attempt)

Inclusion Criteria - "Non-Suicidal Group":

\- Reason for admission: other psychiatric causes (including suicidal thoughts without suicide attempt and non-suicidal self-injurious behavior)

Common Exclusion Criteria:

\- Neither parent available to participate in the intervention

Exclusion Criterion - "Non-Suicidal Group":

\- History of suicidal behavior prior to the current hospitalization

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07430566 · RECHMPL25_0312 · 2025-A02017-42

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗