Skip to main content
Clinical Trials/NCT05912270
NCT05912270
Recruiting
Not Applicable

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

School of Health Sciences Geneva1 site in 1 country150 target enrollmentDecember 18, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Development, Child
Sponsor
School of Health Sciences Geneva
Enrollment
150
Locations
1
Primary Endpoint
Working Memory
Status
Recruiting
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
December 18, 2023
End Date
April 30, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
School of Health Sciences Geneva
Responsible Party
Principal Investigator
Principal Investigator

Clara E James

Full Professor HES-SO

School of Health Sciences Geneva

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)

Outcomes

Primary Outcomes

Working Memory

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials