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Идёт набор NCT07033052

Developing Resilience and Anxiety Management Through the Arts

Без фазы С лечением Anxiety Depression Mood

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: Improvisation + Wellness, Improvisation, Social Craft.
Кому может быть актуально
Состояния в реестре: Anxiety, Depression, Mood. Базовые параметры: 8 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Developing Resilience and Anxiety Management Through the Arts (DRAMA) 2

Обзор

The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents. The researchers will pair theatrical improvisation exercises with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a social craft group on reducing elevated levels of anxiety and depression.

Подробное описание

The purpose of this study is to observe the benefits of theatrical improvisation exercises paired with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a craft control group on reducing elevated levels of anxiety and depression in children and adolescents. It is possible that improvisational techniques could reduce anxiety and depression symptoms because they involve being spontaneous and going into social situations as well as creating something larger than oneself through the group (e.g., creating a scene, working together, etc.). It is also possible that the addition of CBT techniques might lead to a further reduction in anxiety and depression. The study will compare these to a control craft group where youth work on craft projects. The researchers hypothesize that improvisation exercises paired with CBT techniques will be more effective at reducing anxiety and depression than improvisational exercises alone, which we expect will be more effective than a craft group. This improvisation course will not be implemented by licensed therapists or psychologists. Group leaders will be undergraduates, schoolteachers, and graduate students without a background in therapy or counseling (e.g., drama students, music students, etc.) As such, it is important to note that this should not be considered "therapy" or an "intervention." It should not replace intensive treatment for children or adolescents who require a higher level of treatment. Rather, it can be considered a supplementary or preventative group that can help children or adolescents manage feelings of anxiety or depression. The goal of the study is to reduce existing levels of anxiety and depression, prevent the development of new symptoms, and prevent exacerbation of symptoms.

Вмешательства

  • Поведенческое Improvisation + Wellness
    Theatrical improvisation exercises, the theatrical art of performance and storytelling without a script, will be combined with wellness techniques
  • Поведенческое Improvisation
    Theatrical improvisation exercises (the theatrical art of performance and storytelling without a script) will be completed in this arm. These exercises will be fairly similar to that from the improvisation + wellness but without the wellness techniques.
  • Поведенческое Social Craft
    Participants assigned to the Social Craft group will engage in arts and crafts projects and activities

Первичные конечные точки

  • Child Anxiety and Depression (based on Parent Report) [Срок оценки: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group]
  • Child Anxiety and Depression (based on youth report) [Срок оценки: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group]
  • Cognitive Behavioral Technique (CBT) Skill Knowledge [Срок оценки: Baseline, after 9 weeks of the group curriculum, and 3 months post-group]
  • Cognitive Behavioral Technique (CBT) Skills Use [Срок оценки: Baseline, after 9 weeks of the group curriculum, and 3 months post-group]
Вторичные конечные точки (4)
  • Youth mindfulness [Срок оценки: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group]
  • Connectedness [Срок оценки: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group]
  • Emotion regulation [Срок оценки: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group]
  • Self-esteem [Срок оценки: Baseline, after 9 weeks of the group curriculum, and 3 months post-group]

Критерии участия

Критерии включения

  • Between 8 and 17 years of age
  • Individuals must have parental/guardian consent
  • Elevated levels of anxiety or depression based on
  • Screen for Child Anxiety Related Disorders (SCARED) score of 15 or higher, or;
  • Revised Children's Anxiety and Depression Scale (RCADS) Depression T score of 65 or higher, or;
  • Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinician severity rating of 3 on any anxiety disorder or on a mood-related disorder

Критерии исключения

  • Diagnosed with Conduct Disorder or with behavioral symptoms that would make it difficult for the child/adolescent to participate in the group or comply with directions given by the group leader (such as difficulty following instructions, difficulty staying in one's seat, defiance of adults, harming animals or people, threatening others, getting into physical fights, hyperactivity, impulsivity, difficulty waiting for one's turn, etc.)
  • Autism or developmental delays
  • Psychotic symptoms or active suicidality
  • Active Eating Disorders that raise concerns about morbidity and therefore need to be addressed in an intervention and actively monitored
  • Unsteady dosage or recently or impending changes to psychotropic medication(s)
  • Non-English-speaking individuals
  • Wards of the State

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
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Case Western Reserve University — Cleveland

Идентификаторы

NCT: NCT07033052 · STUDY20241298 · NEA AWARD 1891861-38-22

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗