Child DevelopmentNCT01275001
Effects of Music Intervention on the Brain Development of Preschool Children
An observational study of Child Development, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- Unable to provide written consent to participate in the research project
- Unable to complete the MRI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
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.
Read the 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.
- Conditions
- Child Development
- Keywords
- brain, brain development, MRI, preschool children, cortical mantle thickness, hippocampal volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Secondary outcomes (1)
Hippocampal volume
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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Soundy, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275001
- Sponsor's protocol ID
- AIHBG-1360-MRI
- Status last verified
- Jan 2011
- First submitted
- 10 Jan 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12959510Samson 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.
PubMed 16597796Fujioka 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.
PubMed 16959812Peterson 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.
PubMed 8543527Durston 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.
PubMed 12742674Symms 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.
PubMed 15314108Gogtay 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.
PubMed 15148381
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Intervention on the Brain Development of Preschool Children
- ClinicalTrials.gov ID
- NCT01275001
- Acronym / sponsor ID
- AIHBG-1360-MRI
- Conditions
- Child Development
- Keywords
- brain, brain development, MRI, preschool children, cortical mantle thickness, hippocampal volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide written consent to participate in the research project
- Unable to complete the MRI scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Hippocampal volume
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
- Background: PubMed 12959510Ho 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.
- Background: PubMed 16597796Samson 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.
- Background: PubMed 16959812Fujioka 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.
- Background: PubMed 8543527Peterson 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.
- Background: PubMed 12742674Durston 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.
- Background: PubMed 15314108Symms 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.
- Background: PubMed 15148381Gogtay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Soundy, MD principal investigator
Avera McKennan Hospital & University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical mantle thickness (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275001, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2011.