Difficult; Spelling, With Reading Disorder Clinical Trial
Official title:
Effects of Music Education on Domain of Reading and Cognitive Abilities in Children With Reading Difficulties: a Cluster Randomized Clinical Trial
Verified date | July 2011 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ministry of Health |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 270 |
Est. completion date | December 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 10 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of São Paulo - Psychiatry Department | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Instituto ABCD |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Changes in Portuguese achievement | 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. | Change from baseline (July, 2011) in the grades in Portuguese at 5 moths. This period, in Brazil corresponds the second scholar semester July -December | Yes |