Trial Review

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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
Scientific title
Co-Design of a Novel Yoga-Mindfulness Intervention Targeting Anxiety Among Children with Autism Spectrum Disorder: A Randomised Control Trial
Secondary ID [1] 308848 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 328809 0
Anxiety 328810 0
Condition category
Condition code
Mental Health 325819 325819 0 0
Autistic spectrum disorders
Mental Health 325820 325820 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325469 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 334101 0
Change in mean score on Anxiety Disorders Interview Schedule (ADIS-IV): Child and Parent Interview Schedules
(Silverman & Albano, 1996)
Timepoint [1] 334101 0
Baseline, mid-point (four weeks into intervention), on completion of intervention (primary time point) (eight weeks) and three month follow-up.
Secondary outcome [1] 419352 0
Change in mean score on The Intolerance of Uncertainty Scale Child form (IUSC; Comer et al., 2009).
Timepoint [1] 419352 0
Baseline, mid-point (four weeks into intervention), on completion of intervention (eight weeks) and three month follow-up.
Secondary outcome [2] 419353 0
Change in mean score on the Emotion Dysregulation Inventory (EDI; Mazefsky et al., 2018),
Timepoint [2] 419353 0
Baseline, mid-point (four weeks into intervention), on completion of intervention (eight weeks) and three month follow-up.

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.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Traumatic brain injury or other psychiatric disorders (e.g., schizophrenia) that prevents engagement.

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)
Allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur using a computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2023
Actual
Date of last participant enrolment
Anticipated
1/08/2023
Actual
Date of last data collection
Anticipated
12/12/2023
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313069 0
University
Name [1] 313069 0
Murdoch University
Country [1] 313069 0
Australia
Primary sponsor type
Individual
Name
Tundi Loftus
Address
Murdoch University, 90 South Street, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 314761 0
Individual
Name [1] 314761 0
Danielle Mathersul
Address [1] 314761 0
Murdoch University, 90 South Street, Murdoch WA 6150
Country [1] 314761 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312320 0
Murdoch University Human Ethics Research Committee
Ethics committee address [1] 312320 0
90 South Street, Murdoch WA 6150
Ethics committee country [1] 312320 0
Australia
Date submitted for ethics approval [1] 312320 0
16/11/2021
Approval date [1] 312320 0
09/03/2022
Ethics approval number [1] 312320 0
2022/017

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124238 0
Ms Tundi Loftus
Address 124238 0
Murdoch University, 90 South Street, Murdoch WA 6150
Country 124238 0
Australia
Phone 124238 0
+61 8 9360 6542
Fax 124238 0
Email 124238 0
tundi.loftus@murdoch.edu.au
Contact person for public queries
Name 124239 0
Ms Tundi Loftus
Address 124239 0
Murdoch University, 90 South Street, Murdoch WA 6150
Country 124239 0
Australia
Phone 124239 0
+61 8 9360 6542
Fax 124239 0
Email 124239 0
tundi.loftus@murdoch.edu.au
Contact person for scientific queries
Name 124240 0
Ms Tundi Loftus
Address 124240 0
Murdoch University, 90 South Street, Murdoch WA 6150
Country 124240 0
Australia
Phone 124240 0
+61 8 9360 6542
Fax 124240 0
Email 124240 0
tundi.loftus@murdoch.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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.