Effects of Music Intervention on the Brain Development of Preschool Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01275001
First received: January 10, 2011
Last updated: October 4, 2011
Last verified: January 2011
  Purpose

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.


Condition
Child Development

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Music Intervention on the Brain Development of Preschool Children

Resource links provided by NLM:


Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • Cortical mantle thickness [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Hippocampal volume [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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


Enrollment: 34
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275001

Locations
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Timothy Soundy, MD Avera McKennan Hospital & University Health Center
  More Information

Additional Information:
Publications:
Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01275001     History of Changes
Other Study ID Numbers: AIHBG-1360-MRI
Study First Received: January 10, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
brain
brain development
MRI
preschool children
cortical mantle thickness
hippocampal volume

ClinicalTrials.gov processed this record on September 18, 2014