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

Sponsor

School of Health Sciences Geneva (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05912270

Collaborator

University of Geneva, Switzerland (Other), University of Lausanne Hospitals (Other)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 passive 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.

Condition or Disease	Intervention/Treatment	Phase
Development, Child Executive Functions Interventions Music Arts Brain Plasticity Behavior Brain Imaging Magnetic Resonance Imaging Functional Magnetic Resonance Imaging Diffusion Tensor Imaging	Behavioral: Orchestra in Class	N/A

Detailed Description

This cognitive neuroscience study, using a randomized controlled trial (RCT), will investigate the potential cognitive and brain development benefits in young children of 2 years of Orchestra in Class (OC, music practice, experimental group) compared with visual arts (VA, active control group) versus standard education (passive control group, PCG). Both nonverbal art interventions will take place twice a week for 45 minutes in school class-sized groups. The AV groups are used to control for the influences of regular stimulating group interventions and homework, but also to compare specific effects in visual mode with the auditory mode in OC. The PCG controls for overall child development and test-retest effects. We will recruit 150 children aged 6-8 years from public elementary schools, with a random and, therefore equal distribution among the 3 groups.

Data collection will consist of annual (baseline, 1 year, 2 years) comprehensive psychometric testing of executive functions, i.e., far transfer and near transfer, musicality, drawing, 2) academic achievement, and 3) multimodal structural and functional magnetic resonance imaging ((f)MRI), including fMRI with auditory and visual domain working memory tasks.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.The study is a 1) block-randomized, 2) 3-arm, 3) open, 4) monocentric (primary schools in Geneva) 5) national (Switzerland) 6) intervention study.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Orchestra in Class is the Experimental Condition, compared to Visual Arts (Active Control Group) and a Passive Control Group. We will present the study to the participants as a comparison between the 2 art interventions. The Control group can not be masked.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orchestra in Class Children will receive music practice lessons in groups, "Orchestra in Class" (4 different string instruments, violin, viola, cello, double bass) in school class size groups over 2 full years. Interventions, given by 2 professional teachers per class, take place 2*45 minutes per week, completed by daily homework (20 minutes).	Behavioral: Orchestra in Class See arm/group descriptions Other Names: Visual Arts
Active Comparator: Visual Arts Children will receive visual arts lessons in school class size groups over 2 full years. Interventions, given by 2 professional teachers per class, take place 2*45 minutes per week, completed by daily homework (20 minutes).	Behavioral: Orchestra in Class See arm/group descriptions Other Names: Visual Arts
No Intervention: Control Group The children will pass all measurements (they receive a gift voucher of 100 CHF for passing all tests (behavioral and MRI) at each time point. To make participating interesting, we will also explain what scientific research is and organize a yearly workshop, adapted to their age, on neuroscience.

Arm

Intervention/Treatment

Experimental: Orchestra in Class

Children will receive music practice lessons in groups, "Orchestra in Class" (4 different string instruments, violin, viola, cello, double bass) in school class size groups over 2 full years. Interventions, given by 2 professional teachers per class, take place 2*45 minutes per week, completed by daily homework (20 minutes).

Behavioral: Orchestra in Class

See arm/group descriptions

Other Names:

Visual Arts

Active Comparator: Visual Arts

Children will receive visual arts lessons in school class size groups over 2 full years. Interventions, given by 2 professional teachers per class, take place 2*45 minutes per week, completed by daily homework (20 minutes).

Behavioral: Orchestra in Class

See arm/group descriptions

Other Names:

Visual Arts

No Intervention: Control Group

The children will pass all measurements (they receive a gift voucher of 100 CHF for passing all tests (behavioral and MRI) at each time point. To make participating interesting, we will also explain what scientific research is and organize a yearly workshop, adapted to their age, on neuroscience.

Outcome Measures

Primary Outcome Measures

Working Memory [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, 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 Outcome Measures

Plasticity of gray matter brain volume [2 years]
Gray matter brain plasticity, measured by T1-weighted MRI MP2RAGE (Marques & Gruetter, 2013) We expect greater gray matter volume change after 2 years according to the following gradient: Orchestra in Class > Visual Arts > Passive Control Group For the following brain areas: notably in a set of temporal (medial and lateral (auditory)), prefrontal, superior parietal areas, the basal ganglia (striatum), the cerebellum and the corpus callosum (supporting Working Memory, Executive Functions and attention)
Functional brain connectivity [2 years]
Functional brain connectivity, measured with resting-state functional MRI (Leonardi,et al., 2013) We anticipate greater Functional Connectivity (FC) changes following the same gradient Orchestra in Class > Visual Arts > Passive Control Group In the following brain networks: The Default Mode Network (DMN), Central Executive Network (CEN) and Salience Network (SN)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

School grade 3P/4P
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

School of Health Sciences Geneva
University of Geneva, Switzerland
University of Lausanne Hospitals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

School of Health Sciences Geneva

ClinicalTrials.gov Identifier:

NCT05912270

Other Study ID Numbers:

126645

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 22, 2023