Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
114 participants
INTERVENTIONAL
2022-09-11
2027-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Music
57 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.
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 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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* ages 6-8
Exclusion Criteria
* 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
6 Years
8 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Southern California
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Assal Habibi
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Assal Habibi
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brain and Creativity Institute
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UP-22-00056
Identifier Type: -
Identifier Source: org_study_id