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

NCT05912270 | Recruiting

• 1 other identifier: 126645
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Development, Child; Executive Functions; Interventions; Music; Arts; Brain Plasticity; Behavior; Brain Imaging; Magnetic Resonance Imaging; Functional Magnetic Resonance Imaging; Structural Brain Connectivity

Outcome Measures

Primary Outcomes (1)

• Working Memory

  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

  2 years

Secondary Outcomes (2)

• Plasticity of gray matter brain volume

  2 years

• Functional brain connectivity

  2 years

Study Arms (3)

Orchestra in Class

EXPERIMENTAL

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 for 1 hour and 30 minutes per week, completed by daily homework (20-30 minutes).

Behavioral: Orchestra in Class

Visual Arts

EXPERIMENTAL

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 for 1 hour and 30 minutes per week, completed by daily homework (20-30 minutes).

Behavioral: Orchestra in Class

Culture

PLACEBO COMPARATOR

The children will receive six cultural outings per year (museums, concerts, theatre, etc.) and pass all measurements

Behavioral: Orchestra in Class

Interventions

Orchestra in Class BEHAVIORAL

See arm/group descriptions

Also known as: Visual Arts

Culture; Orchestra in Class; Visual Arts

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• School of Health Sciences Geneva: lead
• University of Geneva, Switzerland: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Haute école de santé de Genève HES-SO

Geneva, 1206, Switzerland

RECRUITING

Related Publications (1)

• James CE, Tingaud M, Laera G, Guedj C, Zuber S, Diambrini Palazzi R, Vukovic S, Richiardi J, Kliegel M, Marie D. Cognitive enrichment through art: a randomized controlled trial on the effect of music or visual arts group practice on cognitive and brain development of young children. BMC Complement Med Ther. 2024 Apr 4;24(1):141. doi: 10.1186/s12906-024-04433-1.

  PMID: 38575952 DERIVED

MeSH Terms

Conditions

Arts syndrome; Behavior

Interventions

Artifacts

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Clara James, PhD

  HES-SO University of Applied Sciences and Arts Western Switzerland

  STUDY DIRECTOR

Central Study Contacts

Clara E James, PhD

CONTACT

+41225585419; clara.james@hesge.ch

Yohan Van De Looij, PhD

CONTACT

+41225586779; yohan.vandelooij@hesge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor HES-SO

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

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 22, 2023
• Study Start: December 18, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)