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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]

None

Universal Trial Number (UTN)

None

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low Functioning Autism

Arousal (Cortisol)

Self-Injurious Behaviours

Condition category

Condition code

Mental Health

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]

Prevention

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6904

Recruitment postcode(s) [2]

6005

Recruitment postcode(s) [3]

6872

Recruitment postcode(s) [4]

6151

Recruitment postcode(s) [5]

6050

Recruitment postcode(s) [6]

6064

Recruitment postcode(s) [7]

6155

Recruitment postcode(s) [8]

6100

Recruitment postcode(s) [9]

6101

Recruitment postcode(s) [10]

6979

Recruitment postcode(s) [11]

6981

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Curtin University of Technology, Kent Street, Bentley, W.A, 6102

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/10/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Jeremy Marriott

Address

Curtin University School of Psychology and Speech Pathology, Kent Street, Bentley, Western Australia, 6102

Country

Australia

Phone

+61 8 92667279

Fax

+61 8 92662464

[email protected]

Contact person for scientific queries

Name

Professor Jan Piek

Address

School of Psychology, Curtin University of Technology, Kent Street, Bentley, Western Australia, 6102

Country

Australia

Phone

+61 8 92667790

Fax

+61 8 92662464

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Thesis	No		http://hdl.handle.net/20.500.11937/806

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically