Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000625370
Ethics application status
Approved
Date submitted
7/11/2008
Date registered
10/12/2008
Date last updated
30/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Music Therapy in Social and Nonsocial Behaviours of Autism Spectrum Disorder Children
Scientific title
The Effects of Music Therapy Treatment in the Communication of Children with Autism Spectrum Disorder Measured by the Childhood Autism Rating Scale (CARS)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Capacities of children with Autism Spectrum Disorder 3943 0
Condition category
Condition code
Human Genetics and Inherited Disorders 4137 4137 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 Childhood Autism Rating Scale (CARS). 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 CARS. Finally, the control group will receive treatment the same way that the experimental group.
Intervention code [1] 3775 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 length of the music therapeutic process for the experimental group). The control group will receive music therapy soon after the end of the sessions in the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 5028 0
The mean score of verbal communication in CARS and the mean score of non-verbal communication in CARS.
Timepoint [1] 5028 0
The primary outcome will be mensured before and after of the music therapy treatment of the experimental group.Thus, the outcome will be assessed two times.
Secondary outcome [1] 8448 0
The mean score of social communication in CARS.
Timepoint [1] 8448 0
The secondary outcome will be mensured before and after of the music therapy treatment of the experimental group.Thus, the outcome will be assessed two times.

Eligibility
Key inclusion criteria
Boys aged between 7 and 12 years. Boys who leave in Porto Alegre and nearby cities. Boys with autism disorder, aspeger disorder or Pervasive Developmental Disorder Not Otherwise Specified .
Minimum age
7 Years
Maximum age
12 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The boys who receive music therapy treatment in parallel.
The boys 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)
The research subjects are members of the population of children with Austism Spectrum Disorder in the Pervasive Developmental Disorders Program(PROTID) in Porto Alegre Clinical Hospital, in the city of Porto Alegre, Brazil. Subjects will be chosen by the simple random sampling criteria, using a table of random numbers. Thus, only 24 subjects will be selected among all the subjects of the population who are framed in the inclusion criteria.The randomization will be implemented by a health professional who is not involved in the research. This person 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 24. After, the health professional will put these 24 issues in the Pepi 4.0, making the randomization of the 24 participants into two groups(both with 12 participants). Then, he will organize a list of patients in the experimental group and a list for patients in the control group. The list of 12 patients in the experimental group will be delivered to the two music therapists that will make the attendances.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 24. After, the health professional will put these 24 issues in the Pepi 4.0 Softwere, it making the randomization of the 24 participants into two groups(both with 12 participants).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In this study it is impossible masked or blinded the person who receives the treatment or the person who administers the music therapy treatment. Because the Music Therapy involves actively both the patient and thetherapist in the therapeutic process.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 1346 0
Brazil
State/province [1] 1346 0
Rio Grande do Sul

Funding & Sponsors
Funding source category [1] 4130 0
Government body
Name [1] 4130 0
National Council for Scientific and Technological Development (CNPQ)
Country [1] 4130 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.
Country
Brazil
Secondary sponsor category [1] 3715 0
None
Name [1] 3715 0
Address [1] 3715 0
Country [1] 3715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6200 0
Group of Research and Postgraduate (GPPG)
Ethics committee address [1] 6200 0
Ramiro Barcelos street, 2.350, Porto Alegre city.
Ethics committee country [1] 6200 0
Brazil
Date submitted for ethics approval [1] 6200 0
10/01/2008
Approval date [1] 6200 0
02/04/2008
Ethics approval number [1] 6200 0
08006

Summary
Brief summary
This study aimed to investigate the effects of psychodynamic music therapy in verbal, nonverbal and social communication skills of children with autistic spectrum disorders (ASD). A randomized controlled trial (RCT) was designed to compare individuals treated with psychodynamic music therapy and standard treatment (routine procedures including medical examinations and consultations). The three outcomes were assessed, before and after interventions, with the Brazilian version of the Childhood Autism Rating Scale (CARS-BR). Although as a whole the results did not show statistically significant differences between the groups, the stratified analysis of ASD type showed a positive influence of psychodynamic music therapy in patients with autistic disorder, when compared to patients with the same diagnostics who received standard treatment. The findings on the influence of psychodynamic music therapy in communication skills of autistic patients are not conclusive, but this study confirmed previously reported RCT showing possible benefits of music therapy on nonverbal communication skills of children with autistic disorder.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29091 0
Address 29091 0
Country 29091 0
Phone 29091 0
Fax 29091 0
Email 29091 0
Contact person for public queries
Name 12248 0
Dânae Longo
Address 12248 0
Ramiro Barcelos street, 2.350, Porto Alegre city.
Country 12248 0
Brazil
Phone 12248 0
+55 51 21018008
Fax 12248 0
Email 12248 0
[email protected]
Contact person for scientific queries
Name 3176 0
Lavínia Schuler Faccini
Address 3176 0
Ramiro Barcelos street, 2.350, Porto Alegre city.
Country 3176 0
Brazil
Phone 3176 0
+55 51 99756770
Fax 3176 0
Email 3176 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.