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临床试验/NCT05912270
NCT05912270招募中不适用

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

School of Health Sciences Geneva2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
Working Memory

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Orchestra in Class is the first Experimental Condition, compared to Visual Arts (second Experimental Condition) and an active Control Group that will receive 6 cultural outings per year. We will present the study to the participants as a comparison between the two art interventions and a cultural intervention.

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

结局指标

主要结局

Working Memory

时间窗: 2 years

Working memory (WM) will be assessed by 3 tests: 2 fMRI tests: a visual and an auditory WM test (Vuontela et al., 2003) and the Digit Span Backward from the WISC V (Wechsler Intelligence Scale for Children; Wechsler, 2014). We expect the progress of the mean WM score to show the following evolution after 2 years: Orchestra in Class \> Visual Arts \> Passive Control Group

次要结局

  • Functional brain connectivity(2 years)
  • Plasticity of gray matter brain volume(2 years)

研究者

发起方
School of Health Sciences Geneva
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara E James

Full Professor HES-SO

School of Health Sciences Geneva

研究点 (2)

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