Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000391976
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
14/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Music therapy and children with autism: the effect of family centred music therapy on the social communication skills of young children with autism.
Scientific title
The effect of family centred music therapy on the social communication skills of young children severely affected by autism: a randomised controlled trial.
Secondary ID [1] 259996 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism 265650 0
Condition category
Condition code
Mental Health 265782 265782 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Music therapy. 45 minuted session weekly over 16 weeks. This is a one on one session with a registered music therapist and the child participant's primary carer. Techniques used include live music making such as singing, instrument playing and movement to music.
Intervention code [1] 264413 0
Treatment: Other
Comparator / control treatment
Standard treatment. Participants are enrolled in a government-run early childhood intervention centre providing a family centred philosophy of care. Participants received an average weekly contact time with a multidisciplinary team of 1hr 42 minutes. Children were monitored to ensure they did not begin music therapy sessions, or change their therapy significantly by participating in Applied Behavioural Analysis therapies (intensive, daily one to one therapies).
Control group
Active

Outcomes
Primary outcome [1] 266534 0
Vineland Social Emotional Early Childhood Scales - mean score for interpersonal relationships and play/leisure time subscales.
Timepoint [1] 266534 0
baseline and 16 weeks after randomisation.
Primary outcome [2] 266535 0
MacArthur-Bates Communication Development Inventories (Words and Gestures) - difference scores for all sections.
Timepoint [2] 266535 0
baseline, 16 weeks after randomisation and 24 weeks after randomisation.
Primary outcome [3] 266536 0
Parent-Child Relationship Inventory - mean score for seven subscales.
Timepoint [3] 266536 0
baseline and 16 weeks after randomisation.
Secondary outcome [1] 273993 0
Social Responsiveness Scale - mean score
Timepoint [1] 273993 0
baseline, 16 weeks after randomisation and 24 weeks after randomisation.

Eligibility
Key inclusion criteria
Have a confirmed diagnosis of autism
Are aged between 3.0 - 6.0 years
Limited or no functional communication (limited single word utterances)
Receiving additional services from an Early Intervention centre with a family centred model of care and treatment contact time per child being less than 3 hours per week
Have not yet participated in individual music therapy sessions
Do not also have vision impairments, hearing impairments, ADHD or Cerebral Palsy
Are not receiving ABA therapy provided by a therapist for more than 5 hours a week
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Communication skills at combining words stage
Have participated in individual music therapy sessions
Have vision impairments, hearing impairments, ADHD or Cerebral Palsy
Are receiving ABA therapy provided by a therapist for more than 5 hours a week

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3923 0
3047
Recruitment postcode(s) [2] 3924 0
3082
Recruitment postcode(s) [3] 3925 0
3042

Funding & Sponsors
Funding source category [1] 264883 0
University
Name [1] 264883 0
The University of Melbourne
Country [1] 264883 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Melbourne Conservatorium of Music
151 Barry Street
University of Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 263984 0
None
Name [1] 263984 0
Address [1] 263984 0
Country [1] 263984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266838 0
The University of Melbouren HREC
Ethics committee address [1] 266838 0
Ethics committee country [1] 266838 0
Australia
Date submitted for ethics approval [1] 266838 0
Approval date [1] 266838 0
01/11/2009
Ethics approval number [1] 266838 0
0932487
Ethics committee name [2] 266839 0
The department of education and early childhood development
Ethics committee address [2] 266839 0
Ethics committee country [2] 266839 0
Australia
Date submitted for ethics approval [2] 266839 0
Approval date [2] 266839 0
30/11/2009
Ethics approval number [2] 266839 0
n/a

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

Contacts
Principal investigator
Name 32486 0
Address 32486 0
Country 32486 0
Phone 32486 0
Fax 32486 0
Email 32486 0
Contact person for public queries
Name 15733 0
Grace Thompson
Address 15733 0
Melbourne Conservatorium of Music
151 Barry Street
University of Melbourne VIC 3010
Country 15733 0
Australia
Phone 15733 0
+61414373075
Fax 15733 0
Email 15733 0
[email protected]
Contact person for scientific queries
Name 6661 0
Dr. Katrina McFerran
Address 6661 0
Melbourne Conservatorium of Music
151 Barry Street
University of Melbourne VIC 3010
Country 6661 0
Australia
Phone 6661 0
+6140735251
Fax 6661 0
Email 6661 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.