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Clinical Trials/NCT05502939
NCT05502939
Active, not recruiting
Not Applicable

Effects of Music Training on Neurodevelopment and Associated Health Outcomes

University of Southern California1 site in 1 country114 target enrollmentSeptember 11, 2022
ConditionsMusic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Music
Sponsor
University of Southern California
Enrollment
114
Locations
1
Primary Endpoint
brain inhibition control networks
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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.

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 children between ages 6-8 from communities with limited resources in 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. 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.

Registry
clinicaltrials.gov
Start Date
September 11, 2022
End Date
October 1, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Assal Habibi

Associate Professor

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • 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

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • inhibition control as measured by delayed gratification(24 months)
  • inhibition control as measured by reaction time(24 months)

Study Sites (1)

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