Clinical trial NCT05502939: Music Training and Child Development Study
Official title: Effects of Music Training on Neurodevelopment and Associated Health Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Music
Keywords: Brain
Music training
Children
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 114
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: brain inhibition control networks
timeFrame: 24 months
Secondary outcomes:
measure: inhibition control as measured by reaction time
timeFrame: 24 months
measure: inhibition control as measured by delayed gratification
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Brain and Creativity Institute
state: California
Study officials:
affiliation: University of Southern California
name: Assal Habibi
role: PRINCIPAL_INVESTIGATOR
References: