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Trial registered on ANZCTR
Registration number
ACTRN12611001063909
Ethics application status
Approved
Date submitted
11/10/2011
Date registered
12/10/2011
Date last updated
12/10/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
Music, Arousal and Self-Injurious Behaviour: A 3-Stage Mediating Model For Children With Low Functioning Autism (Study 2)
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Scientific title
Males ages between 6 to 11 years with Low Functioning Autism who exhibit Self-Injurious Behaviours - Study 2 is a randomised control trial – reduction in salivary cortisol levels and video recorded Self-Injurious Behaviour (SIB) whilst listening to music.
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Secondary ID [1]
273194
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Low Functioning Autism
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Arousal (Cortisol)
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Self-Injurious Behaviours
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Condition category
Condition code
Mental Health
279125
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0
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Autistic spectrum disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Research suggests that music can reduce arousal and that reducing arousal can reduce Self-Injurious Behaviour. The intention of this research is to conduct three studies designed to test whether arousal mediates the relationship between music and SIB, hence defining the 3-Stage Mediating Model. Study 1, the first stage of the 3 -Stage Mediating Model, involves the selection, performance and provision of music performed in Rondo, Theme and Variations and Sonata forms rated by primary carers of males with autism from most to least sedate. The first 2 minutes of 6 musical performances, two from each Rondo, Theme and Variations and Sonata forms (appearing in a randomised order) will be rated by primary carers of males with Low Functioning Autism from 1 = least calming to 6 = most calming or that none were calming. Ratings from at least 30 primary carers will then be analysed to reveal the single muscial performance that is agreed to be most calming. This piece of music will be applied to Study 2, the second stage of the 3 -Stage Mediating Model, and Study 3, the third stage of the 3 -Stage Mediating Model.
Study 2: the second stage of the 3 -Stage Mediating Model,
A laboratory based randomised control trial will test if Receptive Music Therapy (listening to music selected in Study 1 as most calming) can reduce salivary cortisol levels and Self Injurious Behaviour frequencies for children with Low Functioning Autism when exposed to 13 minutes video footage of a school bus ride (a Trier Social Stress Test).
Frequency: the participant will attend Curtin University Laboratory once per week for 2 weeks.
Duration: 13 minutes watching a TV playing video footage of a school bus ride. The total time of preparation and collection of saliva for anaylsis will be less than 45 minutes.
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Intervention code [1]
269518
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Prevention
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Intervention code [2]
269519
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Treatment: Other
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Intervention code [3]
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Behaviour
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Comparator / control treatment
Study 2 is a Randomised Control Trial :
Phase 1:
Pre-Test all 30 participants will sit on a bus chair in a laboratory room and watch 13 minutes footage of a school bus journey displayed on a television. Participants will be alone in the closed door laboratory, however, the researcher and primary carer will observe via closed circuit television to ensure that the participants SIB frequency does not escalate to dangerous levels and the RMT is effectively delivered.
At the conclusion of the footage, the primary carer will enter the room to collect saliva samples. Saliva will be analysed for cortisol and video footage will be analysed for SIB frequencies.
Phase 2:
Randomised allocation of 30 participants aged between 6 and 11 years. Non-Music Group (15 children with Low Functioning Autism) or Music Group (15 children with Low Functioning Autism). A simple random allocation technique will be used for this phase.
Phase 3:
Two groups will be formed. Non-Music Group (15 children with Low Functioning Autism) or Music Group (15 children with Low Functioning Autism).
Phase 4:
Exposed to the same conditions as detailed in Phase 1, participants will return to the laboratory one week later, sit on the bus chair in and watch 13 minutes footage of a school bus journey displayed on a television. Participants will be alone in the closed door laboratory, however, the researcher and primary carer will observe via closed circuit television to ensure that the participants SIB frequency does not escalate to dangerous levels and the RMT is effectively delivered. These conditions mirror those of Phase 1.
Participants allocated to the Music group will have headphones applied by the primary carer and listen to music (rated as most calming from Study 1) whilst footage of a school bus journey is displayed.
Participants allocated to the Non-Music group will not listen to music.
For both the Music and Non Music groups, at the conclusion of the footage, the primary carer will enter the room and collect saliva samples. For the Music group, the primary carer will cease the music and remove the headphones.
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Control group
Active
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Outcomes
Primary outcome [1]
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Self-Injurious Behaviour (Study 2)
Self-Injurious Behaviour (SIB) frequency will be recorded as a rate per minute measurement during the first 10 minutes of pre-test (Phase 1) and post-test (Phase 4)periods when the participant is exposed to video footage of a school bus ride.
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Assessment method [1]
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Timepoint [1]
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A significant reduction in SIB frequency should occur for the music group from pre-test (Phase 1) to post test (Phase 4).
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Primary outcome [2]
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Salivary Cortisol (Study 2)
Salivary Cortisol from will be assessed from pre-test (Phase 1) and post-test (Phase 4) samples taken immediately after exposure to the footage of the school bus ride. Saliva samples will be collected via oral swabs and analysed during Phase 1 and Phase 4 to assess the effect of the music in reducing arousal.
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Assessment method [2]
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Timepoint [2]
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A significant reduction in salivary cortisol levels should occur for the music group from pre-test (Phase 1) to post test (Phase 4).
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
Males aged between 6 to 11 years, Diagnosis of Autism and Intellectual Disability defined by a Full Scale Intelligence Quotient of 70 or below, the presence of Self-Injurious Behaviour, travel to school by bus, maintain ongoing treatment for the duration of the trial, no aversion to wearing earphones or having swabs taken for saliva collection as endorsed by primary carer(s).
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Minimum age
6
Years
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Maximum age
11
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Aversion to wearing headphones as stated by primary carer(s), not a school bus traveller, no primary carers to assist in transport or collection of saliva samples.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
State Child Development Centre, Telethon Institute for Child Health Research, Disability Services Commission (DSC), Western Australian Autism Diagnosticians Forum (WAADF), Autism Association of Western Australia, specialist schools that provide educational services for children with autism and a school bus service and parent groups will be emailed to inform of and provide information required to contact Mr Jeremy Marriott. Once primary carers have contacted Jeremy Marriott, he will record and transcribe a telephone interview for each participant to determine eligibility and consent. Allocation concealment will be adhered to via a simple random sampling method whereby Jeremy Marriott will create pieces of paper marked with a de-identified 3-Digit Code representing each participant. These 30 pieces of paper will be shuffled and drawn out of a hat whilst blind folded. A result, participants in Study 2 will be randomly allocated to either the Non Music or Music groups. Even though primary carers will be aware of the group allocation results, participants will be blinded to this in addition to potential limited comprehension as a result of intellectual disability.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As discussed in allocation concealment procedures for Study 2 via a simple random allocation.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Not Applicable
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
4576
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6904
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Recruitment postcode(s) [2]
4577
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6005
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Recruitment postcode(s) [3]
4578
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6872
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Recruitment postcode(s) [4]
4579
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6151
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Recruitment postcode(s) [5]
4580
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6050
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Recruitment postcode(s) [6]
4581
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6064
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Recruitment postcode(s) [7]
4582
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6155
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Recruitment postcode(s) [8]
4583
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6100
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Recruitment postcode(s) [9]
4584
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6101
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Recruitment postcode(s) [10]
4585
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6979
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Curtin University
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Address [1]
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Curtin University of Technology, Kent Street, Bentley, W.A, 6102
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Country [1]
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Australia
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Funding source category [2]
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University
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Name [2]
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Curtin University Faculty Research Initiative 2011: Bringing Biomedical and Clinical Sciences together (Biomedical Sciences and Psychology and Speech Pathology)
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Address [2]
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Curtin University of Technology, Kent Street, Bentley, W.A, 6102
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Country [2]
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
Curtin University School of Psychology and Speech Pathology, Kent Street, Bentley, Western Australia 6102
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
268999
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Country [1]
268999
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Curtin University Human Research Ethics Committee
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Ethics committee address [1]
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Curtin University Human Research Ethics Committee, c/- Office of Research and Development, Curtin University, GPO Box U1987, Perth, Western Australia, 6845
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Ethics committee country [1]
271974
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Australia
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Date submitted for ethics approval [1]
271974
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Approval date [1]
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05/10/2011
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Ethics approval number [1]
271974
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HR 138/2011
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Summary
Brief summary
The aim of Study 2 is to explore the effect of Receptive Music Therapy (RMT) on salivary cortisol and SIB frequency from children with LFA and SIB within a randomised control trial laboratory setting, exposed to a Trier Social Stress Test (TSST). The randomised control trial will include a pre-test for salivary cortisol and SIBs, the random allocation of participants’ into no music and music groups whilst undergoing the TSST and a post-test for salivary cortisol and SIB frequency. Study 2 is designed to investigate the potential relationship between music and SIB as the mediated by level of arousal as illustrated in the 3-Stage Mediating Model. The laboratory environment used in this study provides the controls needed to establish support for the model prior to testing in a naturally stressful setting, the school bus.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jeremy Marriott
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Address
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Curtin University School of Psychology and Speech Pathology, Kent Street, Bentley, Western Australia, 6102
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Country
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Australia
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Phone
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+61 8 92667279
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Fax
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+61 8 92662464
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Jan Piek
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Address
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Curtin University School of Psychology and Speech Pathology, Kent Street, Bentley, Western Australia, 6102
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Country
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Australia
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Phone
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+61 8 92667790
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Fax
7433
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+61 8 92662464
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Email
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[email protected]
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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.
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