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Идёт набор NCT05608551

Animal-assisted Trauma-focused Therapy for Children and Adolescents

Без фазы С лечением Motivation Alliance, Therapeutic

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: Animal-assisted trauma-focused therapy, Standard trauma-focused therapy.
Кому может быть актуально
Состояния в реестре: Motivation, Alliance, Therapeutic. Базовые параметры: 9 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
Швейцария
Следующий шаг
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Официальное название

Effects of a Psychotherapy Group Program for Children and Adolescents With Post-traumatic Stress Symptoms

Обзор

The study aims to investigate how the inclusion of an animal into a trauma-focused group therapy program (TF-CBT) affects therapy motivation of children and adolescents suffering from post-traumatic stress. 80 children and adolescents aged 9 to 17 years are recruited for the study. Participants must have experienced at least one traumatic event leading to post-traumatic stress symptoms. Participants are randomly allocated to one of two groups: animal-assisted trauma-focused therapy (AA TF-CBT) or standard trauma-focused therapy (TF-CBT). Parallel to the groups the parents/guardians of the participating children and adolescents take part in three parent meetings. The results of the study help to gain insights into how the inclusion of animals in trauma-focused psychotherapy can contribute to children and adolescents attending therapy, being more motivated in therapy, and can successfully complete therapy.

Вмешательства

  • Поведенческое Animal-assisted trauma-focused therapy
    Animal-assisted trauma-focused therapy (AA TF-CBT) is a specific form of trauma treatment, in which one or more animals are integrated into the therapy. AA TF-CBT follows a structured, standardized therapy manual.
  • Поведенческое Standard trauma-focused therapy
    Standard trauma-focused therapy (AA TF-CBT) is a standardized trauma therapy following a structured manual.

Первичные конечные точки

  • Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment. [Срок оценки: before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)]
Вторичные конечные точки (5)
  • Change of Therapeutic alliance of children and adolescents from baseline to four weeks after treatment. [Срок оценки: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)]
  • Change of PTSD symptoms of children and adolescents from baseline to four weeks after treatment. [Срок оценки: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)]
  • Change of Self-efficacy of children and adolescents from baseline to four weeks after treatment. [Срок оценки: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)]
  • Change of Quality of Life of children and adolescents from baseline to four weeks after treatment. [Срок оценки: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)]
  • Qualitative assessment of participants' perception of the group therapy at follow-up. [Срок оценки: four weeks after treatment at follow-up]

Критерии участия

Критерии включения

  • Age between 9 and 17 years
  • experienced a traumatic event
  • remembers at least one traumatic event
  • Suffering from posttraumatic stress symptoms (screened via the CATS-2; cut-off ≥ 21; cut-off must be reached by either participant or caregiver)
  • Basic knowledge of child and parents in German to be able to understand content of the session and to fill in questionnaires
  • Informed consent (given by legal guardian for participants younger than 14 years)
  • Positive or neutral attitude towards animals

Критерии исключения

  • Inability to complete questionnaires due to lack of language skills or cognitive impairment
  • Diagnosed autism spectrum disorder; Exclusion only if interaction with others and group ability is limited due to autism
  • Reported significant impairment or safety issue (e.g., active suicidal ideation, acute psychosis)
  • Known abuse of substances used for emotion regulation (e.g. cannabis, alcohol, other hard drugs)
  • Fear of domestic animals
  • Allergic reactions to domestic animals
  • Reported aggressive behavior towards animals in the past

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
Лечение

Центры проведения

Швейцария · 2 центра
  • University of Basel — Basel
  • Psychiatrische Universitätsklinik Zürich — Zurich

Идентификаторы

NCT: NCT05608551 · 2022-01327

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗