Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05912270

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
School of Health Sciences Geneva · Academic / Other
Sex
All
Age
6 Years – 8 Years
Healthy volunteers
Accepted

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)

Conditions

Interventions

TypeNameDescription
BEHAVIORALOrchestra in ClassSee arm/group descriptions

Timeline

Start date
2023-12-18
Primary completion
2026-03-31
Completion
2027-04-30
First posted
2023-06-22
Last updated
2023-12-18

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT05912270. Inclusion in this directory is not an endorsement.