NCT05502939

Brief Summary

This proposed study aims to provide a definitive answer to whether music training benefits brain development, particularly brain inhibition control circuitry and its related health outcomes using a randomized control trial design. In the study, 114 children between ages 6-8 from Los Angeles will be randomly assigned to a 24-month:(1) community-focused after school music training group focused on a traditional strings curriculum at the Colburn school in Los Angeles (MG) or (2) a control group (CG) after-school program comprising of visual arts, book club, ethnic and cultural studies and theater without specific focus on systematic music training or sports. Imaging data will be collected at before and after the intervention (24 months), behavioral assessments will be conducted before the intervention and yearly afterwards, and mid-intervention evaluations will be performed every six months throughout the study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2022Oct 2027

First Submitted

Initial submission to the registry

August 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

September 11, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

5.1 years

First QC Date

August 10, 2022

Last Update Submit

November 11, 2025

Conditions

Keywords

BrainMusic trainingChildren

Outcome Measures

Primary Outcomes (1)

  • brain inhibition control networks

    The primary outcome will be %change in blood-oxygen-level-dependent signal in the brain frontal circuits including the DLPFC, ACC and pre-SMA/SMA evaluated during the two inhibition control tasks.

    24 months

Secondary Outcomes (2)

  • inhibition control as measured by reaction time

    24 months

  • inhibition control as measured by delayed gratification

    24 months

Study Arms (2)

Music

EXPERIMENTAL

57 participants, aged 6-8 Participants will be enrolled in a music training program led by professional trained music instructor of the Colburn School of Music. The music curriculum follows the standard Suzuki training method. Students attend the program 3 days per week, 2 weekday afternoons and one weekend morning. Each session lasts approximately 1 hour long. Each student will be given a string instrument to take home (often a viola or a violin). Each learning day focuses on development of musical elements including rhythm and meter, form, pitch, and performance. Students will take part in annual performances intended to give them a motivational goal, sense of mastery and to share their accomplishments with their peers, family, and community.

Behavioral: Music Program

After School Enrichment Group

ACTIVE COMPARATOR

57 participants, aged 6-8 Participants will be enrolled in an after school program led by instructors and will include visual arts, theater, and general cultural studies. Students attend the program 3 days per week in the afternoon for 1 hour long lessons. Students will take part in an end of the year celebration to share their work with family and community members. Duration and frequency of the after-school program will be matched to the music intervention.

Behavioral: After School Enrichment Program

Interventions

Music ProgramBEHAVIORAL

The cohort of students entering the program at the Colburn school in Los Angeles will be a part of a traditional strings curriculum. Students will join the program on a full scholarship and will be provided all materials necessary for instruction, including an instrument. Students will attend Colburn twice a week in a group setting and will receive private instruction once a week. The program will last 2, 15-week semesters (fall, spring) for 2-years. There will be 2 groups of 10 students. Students will undergo group instruction for 1 hour, 2 times a week and private instruction for 45 minutes, once a week.

Music

The afterschool program will be led by instructors and will include visual arts, theater, and general cultural studies. Students attend the program 3 days per week in the afternoon for 1 hour long lessons. Students will take part in an end of the year celebration to share their work with family and community members.

After School Enrichment Group

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • normal IQ (standard score of \>85 in the Abbreviated Wechsler's Scale of Intelligence)
  • Living in LA within 2 miles radius of the location of the music and the afterschool programs
  • limited resources as defined by the Hollingshead Index cumulative score below 29
  • ages 6-8

You may not qualify if:

  • current diagnosis of neurological or psychiatric disorders
  • prior engagement in formal and systematic music training for more than 6 months
  • previous or current diagnosis of severe hearing loss defined as air conduction thresholds greater than 60 dB HL through 8 kHz or- severe vision loss that is not correctable with prescription eyeglasses or contact lenses
  • non-removable, non-MRI compatible body parts
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain and Creativity Institute

Los Angeles, California, 90089, United States

Location

Study Officials

  • Assal Habibi

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will not be masked to the intervention group assignment but will be blinded to the outcome measures. One research coordinator, fluent in English and in Spanish, will be unblinded to the participants' designated intervention. This individual will be responsible for all necessary follow up communications with the participants and their families. One graduate student research assistant will be unblinded to participant's designated intervention. They will be responsible for completing all fidelity and attendance measures. They will be in direct contact with program staff of the music and the afterschool enrichment program. Dr. Mack as the primary trial statistician and oversight on data analysis will be blinded to intervention assignments. All research staff involved in data analysis will be blinded to the intervention group assignment and all outcome measures.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 16, 2022

Study Start

September 11, 2022

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

November 13, 2025

Record last verified: 2025-11

Locations