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Trial registered on ANZCTR


Registration number
ACTRN12609000692235
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
12/08/2009
Date last updated
7/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Music Therapy in Non-Verbal And Verbal Communication of Children with Multiple Disabilities
Scientific title
The Effects of Music Therapy Treatment in the Non-Verbal And Verbal Communication of Children with Multiple Disabilities Measured by the Evaluation of Language Development
Secondary ID [1] 253363 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Forms of communication in children with multiple disabilities 243401 0
Condition category
Condition code
Human Genetics and Inherited Disorders 239709 239709 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Music Therapy is a treatment that the patient uses music, sounds, voice and musical instruments in a therapeutic process to develop his capacities and his difficulties. The treatment is focused in the relation between patient- music therapist. Thus, music, sounds, voice and musical instruments are the way to promote health benefits for the patient. In this study, each patient will receive 20 sessions of treatment. Each session lasts 30 minutes and happens once a week. Before starting the consultations, all patients will be assessed by Evaluation of Language Development (ELD). In the next moment, it will be executed the randomization and division of patients into two groups (experimental group and control group). After, patients in the experimental group will receive the treatment. Then, the participants in the experimental group and control group will be evaluated again by ELD. Finally, the control group will receive treatment the same way that the experimental group.
Intervention code [1] 237039 0
Treatment: Other
Comparator / control treatment
Hospital Care Activities (consultations, examinations, nutritional guidance, for example). The Hospital Care Activities will happen two or three times a month. These activities will run for 20 weeks (the same duration of the music therapeutic process for the experimental group). The control group receives the same treatment of music lasting 30 minutes each for a total of 20 sessions after the end of the sessions in the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 240477 0
Analyzes of the overall averages of ELD. That is, some comparisons between means that can vary from 49 to 140 points
Timepoint [1] 240477 0
The primary outcome will be measured before and after treatment of music in the experimental group and the control group. Thus, the result will be assessed twice in each group
Secondary outcome [1] 257018 0
Analyzes with the averages of each of the two sections, language comprehension and expressive language.
Timepoint [1] 257018 0
The second outcome will be measured before and after treatment of music in the experimental group and the control group. Thus, the results will be evaluated twice.

Eligibility
Key inclusion criteria
Children with mental disabilities, with losses in motor skills and verbal and nonverbal communication.
Children with autistic spectrum disorder secondary, associated with multiple deficiencies of losses in cognitive, motor and communication.
Children with multiple disabilities where the main cause was a cerebral palsy.
Minimum age
6 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who receive music therapy treatment in parallel. Children who have music or sounds restrictions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A health professional (not involved in the research) organizing the names of patients in alphabetical order. In the next moment, he will provide a number for each patient. The numbers are from 1 to 42. After, the health professional will put these 42 issues in the Pepi 4.0 Softwere, it making the randomization of the 42 participants into two groups (both with 21 participants).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The research subjects are members of the population of children with multiple disabilities of the Center for Integration of Special Children (Kinder), in Porto Alegre, Brazil. The subjects will be chosen by the criterion of simple random sampling, using a table of random numbers. Thus, only 42 individuals will be selected from all individuals of the population that are framed in the criterion for inclusion. The randomization will be performed by a health professional is not involved in research. This person will organize the names of patients in alphabetical order. In the next moment, it will provide a number for each patient. The numbers are from 1 to 42. Then the health professional will ask these 42 questions in PEPI 4.0, making randomization of the 42 participants into two groups (both with 21 participants). Then it will organize a list of patients in the experimental group and a list of patients in the control group. The list of the 21 patients in the experimental group will be delivered to two musicoterapeutas that will make the visits.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The blinding is used with the person who evaluates the results of treatment and the person administering the processing of music.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1924 0
Brazil
State/province [1] 1924 0

Funding & Sponsors
Funding source category [1] 237413 0
Government body
Name [1] 237413 0
National Council for Scientific and Technological Development (CNPq)
Address [1] 237413 0
SEPN street, 507. Brasilia city.CEP 70740-524
Country [1] 237413 0
Brazil
Primary sponsor type
Hospital
Name
Fund of Incentive to Research of Porto Alegre Clinical Hospital (FIPE)
Address
Ramiro Barcelos street, 2.350, Porto Alegre city. CEP 90035-003
Country
Brazil
Secondary sponsor category [1] 236910 0
None
Name [1] 236910 0
Address [1] 236910 0
Country [1] 236910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239545 0
Group of Research and Postgraduate (GPPG)
Ethics committee address [1] 239545 0
Ramiro Barcelos street, 2.350, Porto Alegre city. CEP 90035-003
Ethics committee country [1] 239545 0
Brazil
Date submitted for ethics approval [1] 239545 0
Approval date [1] 239545 0
15/01/2009
Ethics approval number [1] 239545 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29986 0
Address 29986 0
Country 29986 0
Phone 29986 0
Fax 29986 0
Email 29986 0
Contact person for public queries
Name 13233 0
Gustavo Schulz Gattino
Address 13233 0
Ramiro Barcelos street, 2.350, Porto Alegre city. CEP 90035-003
Country 13233 0
Brazil
Phone 13233 0
+55 51 96486886
Fax 13233 0
Email 13233 0
gustavogattino@terra.com.br
Contact person for scientific queries
Name 4161 0
Lavínia Schuler Faccini
Address 4161 0
Ramiro Barcelos street, 2.350, Porto Alegre city. CEP 90035-003
Country 4161 0
Brazil
Phone 4161 0
+55 51 99756770
Fax 4161 0
Email 4161 0
lavinia.faccini@ufrgs.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary