- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01275001
Effects of Music Intervention on the Brain Development of Preschool Children
October 4, 2011 updated by: Avera McKennan Hospital & University Health Center
The purpose of this research study is to learn more about the effects a musical intervention has on typical brain development in preschool-aged children.
Study Overview
Status
Completed
Conditions
Detailed Description
This study will advance the science on brain research in young children by determining the effects of a musical intervention or training on children's brain development.
The study will investigate how regular instruction in the Suzuki-like method of violin affects brain structure and function over the course of approximately five (5) months in preschool-aged children participating in an Early Childhood/Headstart preschool program when compared to a control group of their peers.
Study Type
Observational
Enrollment (Actual)
34
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Research Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants in this research project will be involved with a different research project (Avera Family Wellness Program) investigating the effects of a family-based wellness approach to addressing emotional-behavioral needs of preschool-age children and their families.
The Avera Family Wellness Program (AFWP) consists of a group of children who receive the family-based intervention and a group of control preschool-age children.
Description
Inclusion Criteria:
- Children who are between the ages of 3 and 4.5 years old and are involved in the intervention arm of the Avera Family Wellness Program
- Children who are between the ages of 3 and 4.5 years old and are involved in the control arm of the Avera Family Wellness Program
Exclusion Criteria:
- Unable to provide written consent to participate in the research project
- Unable to complete the MRI scan
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Intervention children
Children who are receiving a Suzuki-like violin instruction through their participation in an Early Childhood/Headstart preschool program
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Control Group
Preschool-age children who are not receiving Suzuki-like violin instruction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortical mantle thickness
Time Frame: 5 months
|
Measure cortical mantle thickness in unsedated preschool-age children with an initial magnetic resonance imaging (MRI) scan and compare to measured cortical mantle thickness after a second MRI scan in the same children after 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hippocampal volume
Time Frame: 5 months
|
Measure hippocampal volumes in unsedated preschool-age children with an initial MRI scan and compare hippocampal volumes in the same children with a second MRI scan after 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Timothy Soundy, MD, Avera McKennan Hospital & University Health Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gogtay N, Giedd JN, Lusk L, Hayashi KM, Greenstein D, Vaituzis AC, Nugent TF 3rd, Herman DH, Clasen LS, Toga AW, Rapoport JL, Thompson PM. Dynamic mapping of human cortical development during childhood through early adulthood. Proc Natl Acad Sci U S A. 2004 May 25;101(21):8174-9. doi: 10.1073/pnas.0402680101. Epub 2004 May 17.
- Ho YC, Cheung MC, Chan AS. Music training improves verbal but not visual memory: cross-sectional and longitudinal explorations in children. Neuropsychology. 2003 Jul;17(3):439-50. doi: 10.1037/0894-4105.17.3.439.
- Samson S, Peretz I. Effects of prior exposure on music liking and recognition in patients with temporal lobe lesions. Ann N Y Acad Sci. 2005 Dec;1060:419-28. doi: 10.1196/annals.1360.035.
- Fujioka T, Ross B, Kakigi R, Pantev C, Trainor LJ. One year of musical training affects development of auditory cortical-evoked fields in young children. Brain. 2006 Oct;129(Pt 10):2593-608. doi: 10.1093/brain/awl247. Epub 2006 Sep 7.
- Peterson BS. Neuroimaging in child and adolescent neuropsychiatric disorders. J Am Acad Child Adolesc Psychiatry. 1995 Dec;34(12):1560-76. doi: 10.1097/00004583-199512000-00006.
- Durston S, Tottenham NT, Thomas KM, Davidson MC, Eigsti IM, Yang Y, Ulug AM, Casey BJ. Differential patterns of striatal activation in young children with and without ADHD. Biol Psychiatry. 2003 May 15;53(10):871-8. doi: 10.1016/s0006-3223(02)01904-2.
- Symms M, Jager HR, Schmierer K, Yousry TA. A review of structural magnetic resonance neuroimaging. J Neurol Neurosurg Psychiatry. 2004 Sep;75(9):1235-44. doi: 10.1136/jnnp.2003.032714.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 10, 2011
First Submitted That Met QC Criteria
January 11, 2011
First Posted (Estimate)
January 12, 2011
Study Record Updates
Last Update Posted (Estimate)
October 6, 2011
Last Update Submitted That Met QC Criteria
October 4, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AIHBG-1360-MRI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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