Music Training and Child Development Study

August 1, 2023 updated by: Assal Habibi, University of Southern California

Effects of Music Training on Neurodevelopment and Associated Health Outcomes

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 Hispanic children between ages 6-8 from underserved communities of LA 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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The investigators will use an RCT design to investigate effects of a music training intervention on brain inhibition control circuitry. Throughout R61(N=40) and R33 (N=74) phases, 114 Hispanic children between ages 6-8 from under-served communities of LA 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.

The investigators anticipate that the R61 phase will take 2 years and R33 will take 3 years to complete. The goal of the R61 phase is to evaluate the feasibility of executing the RCT. Comprehensive behavioral and imaging data will be collected at pre- and post-intervention, and mid-intervention evaluations will be performed every six months throughout the study. The combined R61/R33 phases will include 114 participants and will ultimately provide much needed guidance on the development of larger trials in the field.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • Brain and Creativity Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shan Luo, PhD
        • Principal Investigator:
          • Assal Habibi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music

57 Hispanic 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.

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.

Active Comparator: After School Enrichment Group

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
brain inhibition control networks
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
inhibition control as measured by reaction time
Time Frame: 24 months
Stop signal reaction time during stop signal task
24 months
inhibition control as measured by delayed gratification
Time Frame: 24 months
discounting rate from delay gratification task
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Assal Habibi, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • UP-22-00056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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