- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388881
Effects of Music Education for Children With Reading Difficulties
Effects of Music Education on Domain of Reading and Cognitive Abilities in Children With Reading Difficulties: a Cluster Randomized Clinical Trial
The main objective of this study is to evaluate the effectiveness of music education over a period of five months (three times per week, one hour per day) on the improvement of reading skills (decoding, prosody and phonological awareness) in children (8-10 years) with reading difficulties from poor neighborhoods in the city of Sao Paulo. A second objective is to develop a theoretical model that may explain how acquired musical skills are correlated with the supposed changes in each of the covariates and outcomes in this study.
The study will be administered to 270 children with reading difficulties from 10 different schools (27 children per school). 135 children will have music lessons and 135 will not; therefore, 5 schools will be the control and 5 schools will be the intervention group. The analysis will consider the cluster structure, since the randomization was not conducted at the individual level (i.e., the school level was the randomization unit). For the inferential analysis, generalized estimation models and structural equation modeling will be used.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo, Brazil, 04038-030
- Federal University of São Paulo - Psychiatry Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with reading difficulties
Exclusion Criteria:
- Problems in intelligence (accessed via Raven's Progressive Matrices - above of 25th percentile)
- non-signing of the informed consent by parents is also considered
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music Education
Music education classes take place three times a week, 50 minutes each.
These interventional classrooms will make available keyboard and blockflute.
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The intervention - music classes - will be methodologically and educationally based on the National Curriculum Parameters that were developed in Brazilian in the 80s; the focus here is centered on a modern approach to music education where the traditional process of musical learning is not restricted to the domain of the musical reading (sheet music), but also includes musical improvisation, composition and interpretation.
Children will be encouraged to create their own music; perception and identification of the elements of musical language in production activities will be explained to them by means of voice, body, sound materials and tools available.
Song lyrics, rhymes and rap will be created using elements of musical language not focused purely on the "classical" elements/music.
Other Names:
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No Intervention: Non-intervention
In this arm, children will be not encourage practicing musical activities and will not have musical classes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Reading abilities
Time Frame: Change from Baseline in each reading skills (prosody, non-word/ word reading and phonological awareness) at 5 months
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1)Phonological Awareness Test; 2)Reading Test (consisting of a total of 88 real words and 88 non-words).
3) Prosody will be assessed through WinPitch-Easy Prosody which is a program developed by the engineer and linguist Philippe Martin, University of Toronto, Canada, and the changes in following components will be evaluated:a) Analysis of the temporal prosodic aspects, b) configuration of F0 curve and c) setting curve (F0)
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Change from Baseline in each reading skills (prosody, non-word/ word reading and phonological awareness) at 5 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Portuguese achievement
Time Frame: Change from baseline (July, 2011) in the grades in Portuguese at 5 moths. This period, in Brazil corresponds the second scholar semester July -December
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It will be collected the grades in the Portuguese in the baseline (July) for all children participating in this study in order to study the progress or failure of the children in this scholar subject, being repeated this evaluation at beginning of December.
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Change from baseline (July, 2011) in the grades in Portuguese at 5 moths. This period, in Brazil corresponds the second scholar semester July -December
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jair Mari, Federal University of São Paulo
- Study Director: Hugo Cogo-Moreira, Federal University of São Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP 0433/10
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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