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Идёт набор NCT06203899

Depression and Suicide Prevention in Adolescents Attending Special Schools

Без фазы С лечением Depressive Symptoms

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: Op Volle Kracht, Gatekeeperstraining.
Кому может быть актуально
Состояния в реестре: Depressive Symptoms. Базовые параметры: 12 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Strong Teens and Resilient Minds: School-based Depression and Suicide Prevention in Adolescents Attending Special Schools

Обзор

Depression is a major public health concern. In Dutch adolescents, the prevalence of major depressive disorder is estimated at 3.8%, and one in five adolescents report depressive symptoms. Depression is a risk factor in adolescent suicide. School-based prevention programs, for example the STORM approach, are effective in decreasing depressive symptoms among adolescents with elevated depressive symptoms at screening. However, not all adolescents attend general education. In the Netherlands, 7% of all adolescents enters special education (voortgezet speciaal onderwijs and prakijkonderwijs). They form a vulnerable subgroup concerning developing depressive symptoms and suicidality. To adapt and implement programs for these students, is complex yet crucial. This study aims to screen adolescents, offer them a prevention program to prevent the onset or continuation of depression and evaluate the effectiveness of this program. It is a randomised controlled trial with two conditions. The main study parameter is depressive symptomatology. Secondary study parameters are suicidality, anxiety and somatic complaints. Eligible students enter the second or third grade of special education, presenting elevated depressive symptoms. All adolescents will be screened for depressive and suicidal symptoms. Those reporting suicidality will be guided to specialised care, together with their parents. Adolescents with elevated depressive symptoms in the experimental condition will be offered the CBT-based preventive group training Op Volle Kracht in their school setting. The control condition consists of monitoring, and is offered the training if the intervention has shown to be effective. Participants will fill in longitudinal measurements. At all times, adolescents will be guided to mental health care if necessary. Furthermore, teachers in all participating schools will attend a training on how to detect and address depressive and suicidal symptoms among adolescents. The potential value of the study is that we can offer adolescents in the special educational sector a prevention program that is proven to be effective. In order to achieve this goal we need to evaluate the effectiveness of this prevention program in this target group. We are of opinion, however, that the risks associated with participation can be considered negligible. It is specifically aimed at depressive symptoms, within a population which receives care for other problems.

Вмешательства

  • Поведенческое Op Volle Kracht
    This is a preventive group training based on cognitive behavioural therapy for depression.
  • Поведенческое Gatekeeperstraining
    This is a training for teachers to detect and address depressive symptoms and suicidality in their students .

Первичные конечные точки

  • Depressive symptoms in children and adolescents [Срок оценки: Depressive symptoms will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).]
Вторичные конечные точки (6)
  • The presence of a clinical depression [Срок оценки: The presence of a clinical depression will be measured at T0 (baseline) and T2 (6 months)]
  • Suicidality [Срок оценки: Suicidality will be measured at the screening, at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).]
  • Parent-reported depressive symptoms [Срок оценки: Parent-reported depressive symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).]
  • Anxiety symptoms [Срок оценки: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).]
  • Parent-reported anxiety symptoms [Срок оценки: Anxiety symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).]
  • Somatic symptoms [Срок оценки: Somatic symptoms will be measured at T0 (baseline), T1 (12 weeks), T2 (6 months), and T3 (12 months).]

Критерии участия

Критерии включения

  • Adolescents are in their second or third year of secondary education, ór adolescents will reach the age 14 or 15 in this academic year.
  • Score above cut-off on depression symptom questionnaire (≥ 14 on the CDI-2; Bodden et al. (2016)).

Критерии исключения

  • Adolescents who score 2 on item 8 of the CDI-2 or ≥ 23 on the VOZZ-screen (Kerkhof et al., 2015).
  • Clinical depression based on the clinical interview at baseline ADIS-C (Silverman \& Albano, 1996).
  • Absence of parental permission.
  • Adolescent already receiving treatment for depressive symptomatology.
  • Insufficient knowledge of the Dutch language.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Нидерланды · 1 центр
  • GGZ Oost Brabant — Boekel

Публикации

  • Bodden, D., Braet, C., & Stikkelbroek, Y. (2016). Children's depression inventory-2. In: hogrefe.
  • Bae, Y. (2012). Test review: children's depression inventory 2 (CDI 2). In: Sage Publications: Los Angeles, CA.
  • Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8. PMID 10937431
  • Jellesma FC, Rieffe C, Terwogt MM. The Somatic Complaint List: validation of a self-report questionnaire assessing somatic complaints in children. J Psychosom Res. 2007 Oct;63(4):399-401. doi: 10.1016/j.jpsychores.2007.01.017. PMID 17905048
  • Kerkhof, A., Huisman, A., Vos, C., & Smits, N. (2015). Handleiding VOZZ & VOZZ screen: Vragenlijst over Zelfdoding. Amsterdam: Vrije Universiteit Amsterdam.
  • Klaufus L, Verlinden E, van der Wal M, Kosters M, Cuijpers P, Chinapaw M. Psychometric evaluation of two short versions of the Revised Child Anxiety and Depression Scale. BMC Psychiatry. 2020 Feb 5;20(1):47. doi: 10.1186/s12888-020-2444-5. PMID 32024481
  • Kovacs, M. (2011). Children's Depression Inventory 2nd edition (CDI 2): Technical manual. Multi-Health Systems.
  • Richtlijnen jeugdhulp en jeugdbescherming. (2023). Richtlijn stemmingsproblemen.

Идентификаторы

NCT: NCT06203899 · NL83816.091.23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗