Clinical trial NCT05912270: Orchestra in Class, a Novel Booster for Executive Functions and Brain Development in Young Primary School Children
Official title: Orchestra in Class, a Novel Booster for Executive Functions and Brain Development in Young Primary School Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Development, Child
Executive Functions
Interventions
Music
Arts
Brain Plasticity
Behavior
Brain Imaging
Magnetic Resonance Imaging
Functional Magnetic Resonance Imaging
Structural Brain Connectivity
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
name: University of Lausanne Hospitals
First posted: 2023-06-22
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a 1) block-randomized, 2) 3-arm, 3) open, 4) monocentric (primary schools in Geneva) 5) national (Switzerland) 6) intervention study.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Working Memory
timeFrame: 2 years
Secondary outcomes:
measure: Plasticity of gray matter brain volume
timeFrame: 2 years
measure: Functional brain connectivity
timeFrame: 2 years
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Haute école de santé de Genève HES-SO
Study officials:
affiliation: HES-SO University of Applied Sciences and Arts Western Switzerland
name: Clara James, PhD
role: STUDY_DIRECTOR
References: