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Effects of Music Intervention on the Brain Development of Preschool Children

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ClinicalTrials.gov Identifier: NCT01275001
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : October 6, 2011
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

Tracking Information
First Submitted Date January 10, 2011
First Posted Date January 12, 2011
Last Update Posted Date October 6, 2011
Study Start Date December 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2011)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01275001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 11, 2011)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Music Intervention on the Brain Development of Preschool Children
Official Title Effects of Music Intervention on the Brain Development of Preschool Children
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Child Development
Intervention Not Provided
Study Groups/Cohorts
  • Intervention children
    Children who are receiving a Suzuki-like violin instruction through their participation in an Early Childhood/Headstart preschool program
  • Control Group
    Preschool-age children who are not receiving Suzuki-like violin instruction
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 4, 2011)
34
Original Estimated Enrollment
 (submitted: January 11, 2011)
60
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01275001
Other Study ID Numbers AIHBG-1360-MRI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Avera McKennan Hospital & University Health Center
Study Sponsor Avera McKennan Hospital & University Health Center
Collaborators Not Provided
Investigators
Principal Investigator: Timothy Soundy, MD Avera McKennan Hospital & University Health Center
PRS Account Avera McKennan Hospital & University Health Center
Verification Date January 2011