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Trial registered on ANZCTR


Registration number
ACTRN12610000804088
Ethics application status
Approved
Date submitted
22/09/2010
Date registered
27/09/2010
Date last updated
27/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a music therapy protocol on communication of Brazilian children with autistic disorder: a randomized controlled study
Scientific title
The effects of a music therapy intervention protocol on the communication of Brazilian boys with autistic disorder measured by the scale Children's Communication Checklist 2 (CCC-2), video analysis and analysis of gene expression in the receptors of serotonin, dopamine, oxytocin and vasopressin
Secondary ID [1] 252732 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Communication of children with Autistic Disorder 258231 0
Condition category
Condition code
Human Genetics and Inherited Disorders 258413 258413 0 0
Other human genetics and inherited disorders
Alternative and Complementary Medicine 258443 258443 0 0
Other alternative and complementary medicine
Mental Health 258444 258444 0 0
Autistic spectrum 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 participant- music therapist. Thus, music, sounds, voice and musical instruments are the way to promote health benefits for the participant. In this study, each participant will receive 21 sessions (6 evaluation sessions and 15 treatment sessions). Each session lasts 30 minutes and happens twice a week. Before starting the consultations, all patients will be assessed by the scale Children's Communication Checklist 2 (CCC-2), video analysis and analysis of gene expression in the receptors of serotonin, dopamine, oxytocin and vasopressin. In the next moment, it will be executed the randomization and division of participants into two groups (experimental group and control group). After, participants in the experimental group will receive the treatment. Then, the participants in the experimental group and control group will be evaluated again by the scale Children's Communication Checklist 2 (CCC-2), video analysis and analysis of gene expression in the receptors of serotonin, dopamine, oxytocin and vasopressin. Finally, the control group will receive treatment the same way that the experimental group. The overall duration of this intervention will be 10 weeks.
Intervention code [1] 257250 0
Other interventions
Comparator / control treatment
The control treatment will be play sessions with toys. In 21 meetings of 30 minutes, each participant will have their disposal at a range of toys and an entertainer to perform activities of free play.The free play sessions will occur twice a week. The control group will be offered the intervention on completion of these 21 meetings at 10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 259257 0
The mean score of Children's Communication Checklist 2 (CCC-2).
Timepoint [1] 259257 0
This primary outcome will be measured at baseline and on completion of treatments at 10 weeks.
Primary outcome [2] 259258 0
The duration of pre-verbal communication behaviors measured by video analysis (gaze, musical play, vocalizations and gestures) .
Timepoint [2] 259258 0
This primary outcome will be measured at baseline and on completion of treatments at 10 weeks.
Secondary outcome [1] 265659 0
The gene expression analysis in the receptors of serotonin, dopamine, oxytocin and vasopressin. This outcome will be assessed by the fluorogenic polymerase chain reaction (PCR).
Timepoint [1] 265659 0
This secondary outcome will be measured at baseline and on completion of treatments at 10 weeks.

Eligibility
Key inclusion criteria
This study will include just boys with autistic disorder aged between 5 and 16 years who live in Porto Alegre and nearby cities . This study will acept just boys who study in a special school.
Minimum age
5 Years
Maximum age
16 Years
Sex
Males
Can healthy volunteers participate?
No
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 autistic 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 20 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 20. After, the health professional will put these 20 issues in the Pepi 4.0, making the randomization of the 20 participants into two groups(both with 10 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 10 participants in the experimental group will be delivered to the one music therapist 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 participants in alphabetical order. In the next moment, he will provide a number for each patient. The numbers are from 1 to 20. After, the health professional will put these 20 issues in the Pepi 4.0 Softwere, it making the randomization of the 20 participants into two groups(both with 10 participants).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2929 0
Brazil
State/province [1] 2929 0
Rio Grande do Sul

Funding & Sponsors
Funding source category [1] 257691 0
Government body
Name [1] 257691 0
National Council for Scientific and Technological Development (CNPQ)
Country [1] 257691 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, Rio Grande do Sul State, Brazil

Zip Code 90035-000
Country
Brazil
Secondary sponsor category [1] 256906 0
None
Name [1] 256906 0
Address [1] 256906 0
Country [1] 256906 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259721 0
Group of Research and Postgraduate (GPPG)
Ethics committee address [1] 259721 0
Ethics committee country [1] 259721 0
Brazil
Date submitted for ethics approval [1] 259721 0
14/07/2009
Approval date [1] 259721 0
23/07/2009
Ethics approval number [1] 259721 0
09280

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

Contacts
Principal investigator
Name 31674 0
Address 31674 0
Country 31674 0
Phone 31674 0
Fax 31674 0
Email 31674 0
Contact person for public queries
Name 14921 0
Danae Longo
Address 14921 0
Ramiro Barcelos street, 2.350, Porto Alegre city, Rio Grande do Sul State, Brazil

Zip Code 90035-000
Country 14921 0
Brazil
Phone 14921 0
+55 51 335918008
Fax 14921 0
55 51 335918008
Email 14921 0
[email protected]
Contact person for scientific queries
Name 5849 0
Lavinia Schuler Faccini
Address 5849 0
Ramiro Barcelos street, 2.350, Porto Alegre city, Rio Grande do Sul State, Brazil

Zip Code 90035-000
Country 5849 0
Brazil
Phone 5849 0
+55 51 335918008
Fax 5849 0
Email 5849 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.