- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05502939
Music Training and Child Development Study
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Assal Habibi
- Phone Number: 213 740 3588
- Email: ahabibi@usc.edu
Study Contact Backup
- Name: Shan Luo
- Phone Number: 213 493 9331
- Email: shanluo@usc.edu
Study Locations
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California
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Los Angeles, California, United States, 90089
- Recruiting
- Brain and Creativity Institute
-
Contact:
- Assal Habibi, PhD
- Phone Number: 213-740-3588
- Email: ahabibi@usc.edu
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Contact:
- Email: shanluo@usc.edu
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Principal Investigator:
- Shan Luo, PhD
-
Principal Investigator:
- Assal Habibi, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Assal Habibi, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UP-22-00056
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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