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Идёт набор NCT06315075

Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial

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

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: Dialectical behavior therapy for adolescents (DBT-A).
Кому может быть актуально
Состояния в реестре: Self-harm, Suicidal Ideation, Suicide and Self-harm. Базовые параметры: 13 лет — 18 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
Норвегия
Следующий шаг
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Официальное название

Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open

Обзор

The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are: * to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A. * to investigate how well DBT-A works at 12 months follow-up * to investigate whether pre-treatment factors can predict who will benefit from treatment

Подробное описание

Self-harm and suicidal ideation are prevalent among adolescents and associated with major mental health problems and adverse life events. Dialectical behavior therapy for adolescents (DBT-A) is an empirically supported treatment for self-harm and suicidal ideation in adolescents. However, knowledge is scarce on the effectiveness, long-term outcomes, acceptability, and dropout of DBT-A when implemented and delivered as part of routine clinical practice in the Norwegian national health care system. The main aim of this study is to examine the outcomes from DBT-A in terms of self-harm episodes, suicide attempts, and emergency hospital admission, in addition to acceptability and dropout, when DBT-A is delivered at the Department of Child and adolescent psychiatry (PBU), Haukeland University Hospital (HUS). The study is an uncontrolled pre-post study with one-year follow-up and includes three aims: to evaluate outcomes of DBT-A up to three months post-treatment, at one-year follow-up, and to describe predictors of outcome for adolescents receiving DBT-A.

Вмешательства

  • Поведенческое Dialectical behavior therapy for adolescents (DBT-A)
    A 20-week DBT-A with a weekly individual session (45 minutes), a weekly session of multifamily skills training groups with a caregiver (120 minutes), and telephone consultation with individual therapists outside therapy sessions as needed. The treatment consists of four components and is delivered according to the manual except for the phone coaching that PBU offers workdays until 8 pm.

Первичные конечные точки

  • Lifetime Parasuicide Count Interview [Срок оценки: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up]
  • Number of participants in need of emergency department visits caused by suicidal behavior [Срок оценки: pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up]
Вторичные конечные точки (4)
  • Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ) [Срок оценки: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up]
  • Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10) [Срок оценки: pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up]
  • Barriers to Treatment Participation Scale (BTPS) score [Срок оценки: pre, at dropout at any time between session 1 and end of treatment at session 20.]
  • Perceived benefit of skills training in DBT-A measured by a study specific questionnaire. [Срок оценки: At dropout at any time between session 1 and end of treatment at session 20, or for completers after 20 weeks DBT-A ("post"),]

Критерии участия

Критерии включения

  • Age 13-18 years
  • Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016)
  • Fluency in Norwegian
  • One parent/trusted adult that can participate together with the adolescent.

Критерии исключения

  • Intellectual disability
  • Significant learning or language impairments
  • Autism spectrum disorder
  • Anorexia Nervosa
  • Any psychotic disorder
  • Substance abuse disorder. These patients will be offered treatment as usual at their local outpatient clinic.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • Dept. of child and adolescent psychiatry, Haukeland University Hospital — Bergen

Идентификаторы

NCT: NCT06315075 · 657876

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗