Effects of Music Training on Neurodevelopment and Associated Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- brain inhibition control networks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will not be masked to the intervention group assignment but will be blinded to the outcome measures.
One research coordinator, fluent in English and in Spanish, will be unblinded to the participants' designated intervention. This individual will be responsible for all necessary follow up communications with the participants and their families.
One graduate student research assistant will be unblinded to participant's designated intervention. They will be responsible for completing all fidelity and attendance measures. They will be in direct contact with program staff of the music and the afterschool enrichment program.
Dr. Mack as the primary trial statistician and oversight on data analysis will be blinded to intervention assignments. All research staff involved in data analysis will be blinded to the intervention group assignment and all outcome measures.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
brain inhibition control networks
时间窗: 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.
次要结局
- inhibition control as measured by delayed gratification(24 months)
- inhibition control as measured by reaction time(24 months)
研究者
Assal Habibi
Associate Professor
University of Southern California