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Trial registered on ANZCTR
Registration number
ACTRN12623000352606
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
5/04/2023
Date last updated
5/04/2023
Date data sharing statement initially provided
5/04/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
A Novel Yoga-Mindfulness Intervention Targeting Anxiety Among Children with Autism Spectrum Disorder
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Scientific title
Co-Design of a Novel Yoga-Mindfulness Intervention Targeting Anxiety Among Children with Autism Spectrum Disorder: A Randomised Control Trial
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Secondary ID [1]
308848
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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:
Autism Spectrum Disorder
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Anxiety
328810
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Condition category
Condition code
Mental Health
325819
325819
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0
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Autistic spectrum disorders
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Mental Health
325820
325820
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A novel 8-week yoga intervention will be utilised in this study. Participants will attend a 1-hour online yoga session weekly, in groups of up to 30. The intervention will include components of yoga postures, breath work, mindfulness, and relaxation. The class will be delivered by a yoga instructor and supervised by researchers, as well as the parents of participants if desired. Attendance checklists will be used to monitor intervention adherence.
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Intervention code [1]
325469
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Treatment: Other
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Comparator / control treatment
There will be a treatment as usual waitlist control group. Treatment as usual will comprise of existing interventions the children partake in, such as behaviour therapy, speech therapy etc. However, these interventions do not specifically target the outcome of anxiety.
The control group will be offered the intervention after the three month follow-up data has been collected from the experiment group.
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Control group
Active
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Outcomes
Primary outcome [1]
334101
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Change in mean score on Anxiety Disorders Interview Schedule (ADIS-IV): Child and Parent Interview Schedules
(Silverman & Albano, 1996)
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Assessment method [1]
334101
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Timepoint [1]
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Baseline, mid-point (four weeks into intervention), on completion of intervention (primary time point) (eight weeks) and three month follow-up.
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Secondary outcome [1]
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Change in mean score on The Intolerance of Uncertainty Scale Child form (IUSC; Comer et al., 2009).
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Assessment method [1]
419352
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Timepoint [1]
419352
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Baseline, mid-point (four weeks into intervention), on completion of intervention (eight weeks) and three month follow-up.
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Secondary outcome [2]
419353
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Change in mean score on the Emotion Dysregulation Inventory (EDI; Mazefsky et al., 2018),
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Assessment method [2]
419353
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Timepoint [2]
419353
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Baseline, mid-point (four weeks into intervention), on completion of intervention (eight weeks) and three month follow-up.
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Eligibility
Key inclusion criteria
Children aged 6 to 18 years with an Autism diagnosis (DSM-V, or ICD-10). As this study uses language-based tests and self-report questionnaires in English, we are looking for native English speakers or multilingual families who have basic English proficiency.
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Minimum age
6
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Traumatic brain injury or other psychiatric disorders (e.g., schizophrenia) that prevents engagement.
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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)
Allocation will be concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur using a computer program.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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
10/04/2023
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Actual
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Date of last participant enrolment
Anticipated
1/08/2023
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Actual
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Date of last data collection
Anticipated
12/12/2023
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Actual
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Sample size
Target
102
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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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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Murdoch University
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Address [1]
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90 South Street, Murdoch WA 6150
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Country [1]
313069
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Australia
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Primary sponsor type
Individual
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Name
Tundi Loftus
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Address
Murdoch University, 90 South Street, Murdoch WA 6150
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Country
Australia
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Secondary sponsor category [1]
314761
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Individual
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Name [1]
314761
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Danielle Mathersul
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Address [1]
314761
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Murdoch University, 90 South Street, Murdoch WA 6150
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Country [1]
314761
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312320
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Murdoch University Human Ethics Research Committee
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Ethics committee address [1]
312320
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90 South Street, Murdoch WA 6150
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Ethics committee country [1]
312320
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Australia
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Date submitted for ethics approval [1]
312320
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16/11/2021
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Approval date [1]
312320
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09/03/2022
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Ethics approval number [1]
312320
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2022/017
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Summary
Brief summary
Extensive research has demonstrated that yoga is beneficial for general physical and mental health and well-being. However, only limited yoga-based interventions have been developed specifically for children living with Autism, with mixed results in reducing psychological distress and enhancing wellbeing.
This study aims to understand the effects of a novel yoga intervention for reducing anxiety in children (aged 6 to 18) with Autism. This intervention is developed and co-designed with considerations of the special needs of children living with Autism, and it is primarily focusing on yoga postures, mindfulness awareness, breathing and relaxation training. The classes will run online, 1 hour per week for 8 weeks in a group setting.
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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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Ms Tundi Loftus
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Address
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Murdoch University, 90 South Street, Murdoch WA 6150
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Country
124238
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Australia
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Phone
124238
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+61 8 9360 6542
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Fax
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Email
124238
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[email protected]
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Contact person for public queries
Name
124239
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Ms Tundi Loftus
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Address
124239
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Murdoch University, 90 South Street, Murdoch WA 6150
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Country
124239
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Australia
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Phone
124239
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+61 8 9360 6542
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Fax
124239
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Email
124239
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[email protected]
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Contact person for scientific queries
Name
124240
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Ms Tundi Loftus
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Address
124240
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Murdoch University, 90 South Street, Murdoch WA 6150
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Country
124240
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Australia
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Phone
124240
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+61 8 9360 6542
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Fax
124240
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Email
124240
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPD not intended to be shared at this stage due to potential parent concerns about information pertaining to their children being publicly accessible.
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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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