跳至主要内容
临床试验/NCT01388881
NCT01388881Unknown不适用

Effects of Music Education on Domain of Reading and Cognitive Abilities in Children With Reading Difficulties: a Cluster Randomized Clinical Trial

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
270
试验地点
2
主要终点
Changes in Reading abilities

研究概览

简要总结

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.

详细描述

In order to form the sample of children with reading difficulties, the primary school teachers of ten public schools in the city of Sao Paulo were first asked to suggest names of children with below average reading abilities. From these suggested names, the teachers were given a "scale of reading skill" that considers the children´s silent and oral reading and generates a score that divides the children into four skill levels from which only children with the worst indicators were selected (i.e., students who read more or less and students who read poorly). Then, the second evaluation phase was conducted with these children with reading difficulties: in this phase a hearing and speech pathologist conducted a Simplified Assessment of Central Auditory Processing in order to evaluate the auditory function, an ophthalmologist evaluated the visual acuity using the Snellen Scale and a psychologist evaluated non-verbal intelligence using the Raven's Progressive Matrices. These three evaluations were done individually, in previously reserved rooms at the schools (in loco) and during school hours previously established with the administration and teaching staff. Only scores below the 25th percentile in the Ravens´s Progressive Matrices were considered as exclusion criteria; the others variables two cited above will be entered as control variable. It was decided to group these three initial evaluations together, because they are simpler and can be conducted quickly. In the next step, we evaluated the outcomes and other types of covariates in the children's level (i.e., musical abilities, socio-demographic characteristics, familiar background). At the end of this first wave of outcome evaluation, the intervention will initiate in the schools previously and randomly selected for the intervention. The study will provide block flutes, keyboards and two musical teachers per school (two teachers for 27 children in each of the schools that were selected for the intervention). The musical educators will follow the same syllabus program in order to avoid educational bias and to control the process of teaching, making the classes as similar as possible. Every two weeks over the intervention, the ten music educators will be called in order to review the educational and methodological plan and share the positive and negative experiences obtained during the teaching process.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with reading difficulties

排除标准

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

结局指标

主要结局

Changes in Reading abilities

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

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)

次要结局

  • 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)

研究者

发起方
Federal University of São Paulo
申办方类型
Other

研究点 (2)

Loading locations...

相似试验