Difficult; Spelling, With Reading DisorderNCT01388881
Effects of Music Education for Children With Reading Difficulties
A study testing Music Education in people with Difficult; Spelling, With Reading Disorder, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Difficult; Spelling, With Reading Disorder
- What is being tested?
- Music Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Dec 2011
- Phase
- Interventional
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with reading difficulties
Who cannot join
- Problems in intelligence (accessed via Raven's Progressive Matrices - above of 25th percentile)
- non-signing of the informed consent by parents is also considered
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of São Paulo - Psychiatry Department
São Paulo, São Paulo, 04038-030
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Music Education
- Keywords
- reading difficulties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music EducationOther
Also called Music Education is an Educational intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Education | Experimental | Music education classes take place three times a week, 50 minutes each. These interventional classrooms will make available keyboard and blockflute. Receives: Other: Music Education |
| Non-intervention | No intervention | In this arm, children will be not encourage practicing musical activities and will not have musical classes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: Change from baseline (July, 2011) in the grades in Portuguese at 5 moths. This period, in Brazil corresponds the second scholar semester July -December
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult; Spelling, With Reading DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Instituto ABCD
- Investigators
- Jair Mari, Principal investigator, Federal University of São PauloHugo Cogo-Moreira, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388881
- Sponsor's protocol ID
- CEP 0433/10
- Status last verified
- Jul 2011
- First submitted
- 29 Jun 2011
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Education on Domain of Reading and Cognitive Abilities in Children With Reading Difficulties: a Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01388881
- Acronym / sponsor ID
- CEP 0433/10
- Keywords
- reading difficulties
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Instituto ABCD
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 7 Jul 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Education | Experimental | Other: Music EducationMusic education classes take place three times a week, 50 minutes each. These interventional classrooms will make available keyboard and blockflute. |
| Non-intervention | No intervention | –In this arm, children will be not encourage practicing musical activities and will not have musical classes. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with reading difficulties
Key exclusion criteria (2 listed)
- Problems in intelligence (accessed via Raven's Progressive Matrices - above of 25th percentile)
- non-signing of the informed consent by parents is also considered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music EducationAlso: Music Education is an Educational interventionThe 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 | Music Education |
Primary outcome
Changes in Reading abilities
Time frame: 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)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
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.
Jair Mari principal investigator
Federal University of São Paulo
Hugo Cogo-Moreira study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Education in people with Difficult; Spelling, With Reading Disorder, run by Federal University of São Paulo at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Jul 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 Brazil. 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?
Results are not available in the source record.
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?
Changes in Reading abilities (time frame: Change from Baseline in each reading skills (prosody, non-word/ word reading and phonological awareness) at 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2011.