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Идёт набор NCT05912270

Orchestra in Class, a Novel Booster for Executive Functions and Brain Development in Young Primary School Children

Без фазы С лечением Development, Child Executive Functions Interventions Music

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: Orchestra in Class.
Кому может быть актуально
Состояния в реестре: Development, Child, Executive Functions, Interventions, Music. Базовые параметры: 6 лет — 8 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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Обзор

How to optimally stimulate the developing brain is still unclear. Executive functions (EF) exhibited substantially stronger far transfer effects in children who learned to play a musical instrument than in children who acquired other arts. What is crucially lacking is a large-scale, long-term genuine randomized controlled trial (RCT) in cognitive neuroscience, comparing musical instrumental training (MIP) to another art form and a control group. Collected data of this proposal will allow, using machine learning, to build a data-driven multivariate model of children's interconnected brain and EF development over the first 2 years of their academic curriculum (6-8 years), with or without music or other art training.

Подробное описание

This cognitive neuroscience study, employing a randomized controlled trial (RCT), aims to investigate the potential cognitive and brain development benefits in young school children from two-year interventions: Orchestra in Class (OC, music practice, experimental group) compared with Visual Arts (VA, second experimental group) versus Standard Education (active control group (CG)). The CG will be offered six cultural outings per year (concerts, museums, theatres, etc.). Both nonverbal art interventions will be given weekly interventions for 1 hour and 30 minutes in school class sized groups. The VA groups serve to control for the influences of regular stimulating group interventions and homework, and also to compare specific effects in visual mode with the auditory mode in OC. The CG controls for overall child development and test-retest effects.

We plan to recruit 150 children aged 6-8 years from public elementary schools, ensuring a random and therefore equal distribution among the three groups. Data collection will involve annual comprehensive psychometric testing (baseline, after 1 year, after 2 years) of executive functions, i.e., far transfer and near transfer, musicality, drawing, academic achievement, and multimodal structural and functional magnetic resonance imaging (fMRI), including fMRI with auditory and visual domain working memory tasks.

By utilizing multivariate analyses and integrating behavioral and brain data through machine learning, we aim to create a data-driven model of the development of executive functions at the behavioral and brain levels in young children at the beginning of their school careers (6 to 8 years old), both without and with an enriched environment (musical practice versus visual arts)

Вмешательства

  • Поведенческое Orchestra in Class
    See arm/group descriptions

Первичные конечные точки

  • Working Memory [Срок оценки: 2 years]
Вторичные конечные точки (2)
  • Plasticity of gray matter brain volume [Срок оценки: 2 years]
  • Functional brain connectivity [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • School grade 3P/4P (3rd and 4th year of elementary school (6-8-year-old children)
  • Right-handedness
  • Sufficient Mastery of the French Language
  • Able to give oral informed consent (child)
  • Able to give written informed consent (parent)

Критерии исключения

  • Non-consent (children and or parents)
  • Repeated or skipped a class with respect to standard curriculum
  • Not corrected/severe hearing deficits
  • Not corrected/severe vision deficits
  • Severe neurodevelopmental disorders (eg. severe dyslexia, severe ADHD)
  • Older than 7 at the beginning of the school year if 3P
  • Older than 8 at the beginning of the school year if 4P
  • Protocolled music instrumental practice in the preceding year
  • Protocolled visual arts courses in the preceding year
  • MRI incompatibility (physical or psychological)
  • Psychometric battery incompatibility (psychological)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Швейцария · 1 центр
  • Haute école de santé de Genève HES-SO — Geneva

Публикации

  • James CE, Tingaud M, Laera G, Guedj C, Zuber S, Diambrini Palazzi R, Vukovic S, Richiardi J, Kliegel M, Marie D. Cognitive enrichment through art: a randomized controlled trial on the effect of music or visual arts group practice on cognitive and brain development of young children. BMC Complement Med Ther. 2024 Apr 4;24(1):141. doi: 10.1186/s12906-024-04433-1. PMID 38575952

Идентификаторы

NCT: NCT05912270 · 126645

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗