Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001064998
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 3
Scientific title
Males ages between 6 to 11 years with Low Functioning Autism who exhibit Self-Injurious Behaviours - randomised control trial - reduction in salivary cortisol levels and video recorded Self-Injurious Behaviour (SIB) whilst listening to music - Study 3
Secondary ID [1] 273197 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Functioning Autism 278951 0
Arousal (Cortisol) 278952 0
Self-Injurious Behaviours 278953 0
Condition category
Condition code
Mental Health 279132 279132 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 (ACTRN12611001063909)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). This study is designed to assess the trial within a laboratory setting prior to its application within a naturalistic setting; an actual school bus.
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.

Study 3
A single case design will test if Receptive Music Therapy (listening to music rated as most calming from Study 1, then applied in Study 2) can reduce salivary cortisol levels and Self Injurious Behaviour frequencies for children with Low Functioning Autism when travelling to school by bus (an applied version of the Trier Social Stress Test).
Frequency: one day per week over 4 consecutive weeks
Duration: 1 hour per week
Intervention code [1] 269526 0
Prevention
Intervention code [2] 269527 0
Treatment: Other
Intervention code [3] 269528 0
Behaviour
Comparator / control treatment
Study 3 is a Single case ABAB design including a maximum of 6 participants.
Phase A, occuring on Friday of week 1 and week 3 of the ABAB design will involve the researcher riding the school bus to desensitise the participant to the presence of an observer. In this Non-Music condition, participants will not listen to music. Video footage of the school bus ride will be recorded and assessed for Self-Injurious Behaviour frequencies. Saliva will be sampled once at school and analysed for cortisol levels. The researcher will support the school staff to secure and collect the saliva sample if required.

In Phase B, known as the Music condition and occuring on Friday of week 2 and week 4 of the ABAB design, will see participants ride to school by bus whist listening to music via headphones. Video footage of the school bus ride will be recorded and assessed for Self-Injurious Behaviour frequencies. Saliva will be sampled once at school and analysed for cortisol levels. The researcher will also observe and record SIB frequencies. On Phase B mornings, the primary carer will activate the audio device prior to applying the earphones to the participant. The participant will listen to a repeated recording of the composition rated from Study 1and applied in Study 2 for the entire bus journey to school. If the participant’s behaviour contravenes the Public Transport Authority’s behaviour policy at any time, the researcher will activate the stop button on the audio player. Once arrived at school, school staff will enter the bus and collect a saliva sample. The researcher will remain on the bus during this time to assist and collect the sample if required. The school staffs will then stop the music, remove the audio player and place it in the participant’s school bag.

Participants from Study 1 or Study 2 are ineligable to participate in Study 3 to negate carry over effects.
The timeframe fror the ABAB design is defined as:
Phase A: Friday of week 1
Phase B: Friday of week 2
Phase A: Friday of week 3
Phase B: Friday of week 4
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279776 0
Self-Injurious Behaviour
Study 3: Self Injurious Behaviour frequency will be recorded as a rate per minute measurement during the first 10 minutes of pre and post-test periods when the participant is exposed to a school bus ride.
Timepoint [1] 279776 0
SIB measures should fluctuate in tandem across the Phases 1,2,3 and 4 of the study. Decrease from Phase 1 (Non Music on the Bus Week) to Phase 2 (Music on the Bus Week), increase from Phase 2 to Phase 3, and decrease from Phase 3 to Phase 4.
Secondary outcome [1] 294405 0
Salivary Cortisol
Study 3:
Firstly, to capture the behaviour of each participants cortisol, a Cortisol Awakening Response (CAR) profile will be created by assessing cortisol levels in saliva from samples taken during one morning at awakening (AW), 15 minutes (AW15), 30 minutes (AW30), 45 minutes (AW45) and 60 minutes (AW60) after awakening.
Through the 4 week trial, saliva samples will be collected via oral swabs and analysed during Phase 1, 2,3 and 4 to assess the effect of the music in reducing arousal.
Timepoint [1] 294405 0
Cortisol levels should fluctuate in tandem across the Phases 1,2,3 and 4 of the study. Decrease from Phase 1 (Non Music on the Bus Week) to Phase 2 (Music on the Bus Week), increase from Phase 2 to Phase 3, and decrease from Phase 3 to Phase 4.

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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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. Even though primary carers will be aware of the inention of the research, 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)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4586 0
6904
Recruitment postcode(s) [2] 4587 0
6005
Recruitment postcode(s) [3] 4588 0
6872
Recruitment postcode(s) [4] 4589 0
6151
Recruitment postcode(s) [5] 4590 0
6050
Recruitment postcode(s) [6] 4591 0
6064
Recruitment postcode(s) [7] 4592 0
6155
Recruitment postcode(s) [8] 4593 0
6100
Recruitment postcode(s) [9] 4594 0
6101
Recruitment postcode(s) [10] 4595 0
6979
Recruitment postcode(s) [11] 4596 0
6981

Funding & Sponsors
Funding source category [1] 270021 0
University
Name [1] 270021 0
Curtin University
Country [1] 270021 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University of Technology, Kent Street, Bentley, W.A, 6102
Country
Australia
Secondary sponsor category [1] 269001 0
None
Name [1] 269001 0
Address [1] 269001 0
Country [1] 269001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271978 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 271978 0
Curtin University Human Research Ethics Committee, c/- Office of Research and Development, Curtin University, GPO Box U1987, Perth, Western Australia, 6845
Ethics committee country [1] 271978 0
Australia
Date submitted for ethics approval [1] 271978 0
Approval date [1] 271978 0
05/10/2011
Ethics approval number [1] 271978 0
HR 138/2011

Summary
Brief summary
A single-case ABAB design will assess salivary cortisol data and SIB frequency captured via video footage when the child travels in the morning from home to school by bus. Children will be exposed to two conditions. The Non-Music condition will see the child riding the school bus without listening to music. The Music condition will see the child listening to music whilst travelling to school by bus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33260 0
Address 33260 0
Country 33260 0
Phone 33260 0
Fax 33260 0
Email 33260 0
Contact person for public queries
Name 16507 0
Jeremy Marriott
Address 16507 0
Curtin University School of Psychology and Speech Pathology, Kent Street, Bentley, Western Australia, 6102
Country 16507 0
Australia
Phone 16507 0
+61 8 92667279
Fax 16507 0
+61 8 92662464
Email 16507 0
[email protected]
Contact person for scientific queries
Name 7435 0
Professor Jan Piek
Address 7435 0
School of Psychology, Curtin University of Technology, Kent Street, Bentley, Western Australia, 6102
Country 7435 0
Australia
Phone 7435 0
+61 8 92667790
Fax 7435 0
+61 8 92662464
Email 7435 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4324ThesisNo http://hdl.handle.net/20.500.11937/806

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