NCT01275001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 6, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

January 10, 2011

Last Update Submit

October 4, 2011

Conditions

Child Development

Keywords

brainbrain developmentMRIpreschool childrencortical mantle thicknesshippocampal volume

Outcome Measures

Primary Outcomes (1)

  • Cortical mantle thickness

    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 Outcomes (1)

  • Hippocampal volume

    5 months

Study Arms (2)

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

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Unable to provide written consent to participate in the research project
  • Unable to complete the MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (7)

  • 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.

    PMID: 12959510BACKGROUND

  • 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.

    PMID: 16597796BACKGROUND

  • 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.

    PMID: 16959812BACKGROUND

  • 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.

    PMID: 8543527BACKGROUND

  • 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.

    PMID: 12742674BACKGROUND

  • 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.

    PMID: 15314108BACKGROUND

  • 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.

    PMID: 15148381BACKGROUND

Study Officials

  • Timothy Soundy, MD

    Avera McKennan Hospital & University Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 12, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 6, 2011

Record last verified: 2011-01

Locations

US(1)