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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)
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.
Secondary ID [1] 273194 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Functioning Autism 278944 0
Arousal (Cortisol) 278945 0
Self-Injurious Behaviours 278946 0
Condition category
Condition code
Mental Health 279125 279125 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269518 0
Prevention
Intervention code [2] 269519 0
Treatment: Other
Intervention code [3] 269520 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 279769 0
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.
Timepoint [1] 279769 0
A significant reduction in SIB frequency should occur for the music group from pre-test (Phase 1) to post test (Phase 4).
Primary outcome [2] 279784 0
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.
Timepoint [2] 279784 0
A significant reduction in salivary cortisol levels should occur for the music group from pre-test (Phase 1) to post test (Phase 4).
Secondary outcome [1] 294417 0
Nil
Timepoint [1] 294417 0
Nil

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).
Minimum age
6 Years
Maximum age
11 Years
Sex
Males
Can healthy volunteers participate?
No
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.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4576 0
6904
Recruitment postcode(s) [2] 4577 0
6005
Recruitment postcode(s) [3] 4578 0
6872
Recruitment postcode(s) [4] 4579 0
6151
Recruitment postcode(s) [5] 4580 0
6050
Recruitment postcode(s) [6] 4581 0
6064
Recruitment postcode(s) [7] 4582 0
6155
Recruitment postcode(s) [8] 4583 0
6100
Recruitment postcode(s) [9] 4584 0
6101
Recruitment postcode(s) [10] 4585 0
6979

Funding & Sponsors
Funding source category [1] 270015 0
University
Name [1] 270015 0
Curtin University
Country [1] 270015 0
Australia
Funding source category [2] 270016 0
University
Name [2] 270016 0
Curtin University Faculty Research Initiative 2011: Bringing Biomedical and Clinical Sciences together (Biomedical Sciences and Psychology and Speech Pathology)
Country [2] 270016 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University School of Psychology and Speech Pathology, Kent Street, Bentley, Western Australia 6102
Country
Australia
Secondary sponsor category [1] 268999 0
None
Name [1] 268999 0
Address [1] 268999 0
Country [1] 268999 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271974 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 271974 0
Ethics committee country [1] 271974 0
Australia
Date submitted for ethics approval [1] 271974 0
Approval date [1] 271974 0
05/10/2011
Ethics approval number [1] 271974 0
HR 138/2011

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

Contacts
Principal investigator
Name 33258 0
Address 33258 0
Country 33258 0
Phone 33258 0
Fax 33258 0
Email 33258 0
Contact person for public queries
Name 16505 0
Jeremy Marriott
Address 16505 0
Curtin University School of Psychology and Speech Pathology, Kent Street, Bentley, Western Australia, 6102
Country 16505 0
Australia
Phone 16505 0
+61 8 92667279
Fax 16505 0
+61 8 92662464
Email 16505 0
jeremy.k.marriott@postgrad.curtin.edu.au
Contact person for scientific queries
Name 7433 0
Professor Jan Piek
Address 7433 0
Curtin University School of Psychology and Speech Pathology, Kent Street, Bentley, Western Australia, 6102
Country 7433 0
Australia
Phone 7433 0
+61 8 92667790
Fax 7433 0
+61 8 92662464
Email 7433 0
J.Piek@curtin.edu.au

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

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