Music Training and Child Development Study

Music Clinical Trial

Official title:

Effects of Music Training on Neurodevelopment and Associated Health Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502939
• Other study ID #: UP-22-00056
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2022
• Est. completion date: October 1, 2027

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: Assal Habibi
• Phone: 213 740 3588
• Email: ahabibi[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Music

Intervention

Behavioral:
• Music Program
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.
• After School Enrichment Program
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.

Locations

Country	Name	City	State
United States	Brain and Creativity Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	inhibition control as measured by reaction time	Stop signal reaction time during stop signal task	24 months
Secondary	inhibition control as measured by delayed gratification	discounting rate from delay gratification task	24 months