NCT01388881

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

3 months

First QC Date

June 29, 2011

Last Update Submit

July 22, 2011

Conditions

Keywords

reading difficulties

Outcome Measures

Primary Outcomes (1)

  • Changes in Reading abilities

    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)

    Change from Baseline in each reading skills (prosody, non-word/ word reading and phonological awareness) at 5 months

Secondary Outcomes (1)

  • Changes in Portuguese achievement

    Change from baseline (July, 2011) in the grades in Portuguese at 5 moths. This period, in Brazil corresponds the second scholar semester July -December

Study Arms (2)

Music Education

EXPERIMENTAL

Music education classes take place three times a week, 50 minutes each. These interventional classrooms will make available keyboard and blockflute.

Other: Music Education

Non-intervention

NO INTERVENTION

In this arm, children will be not encourage practicing musical activities and will not have musical classes.

Interventions

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.

Also known as: Music Education is an Educational intervention
Music Education

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with reading difficulties

You may not qualify if:

  • Problems in intelligence (accessed via Raven's Progressive Matrices - above of 25th percentile)
  • non-signing of the informed consent by parents is also considered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo - Psychiatry Department

São Paulo, São Paulo, 04038-030, Brazil

Location

Study Officials

  • Jair Mari

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR
  • Hugo Cogo-Moreira

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2011

First Posted

July 7, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations