Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000912381
Ethics application status
Approved
Date submitted
14/06/2017
Date registered
22/06/2017
Date last updated
7/07/2020
Date data sharing statement initially provided
10/05/2019
Date results information initially provided
10/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of mind-body skills training based on yoga techniques in children on the Autism Spectrum
Scientific title
A randomized trial of the effectiveness of yoga-based mind-body skills training on self-regulation, anxiety, emotion and body awareness, and sleep in children on the autism spectrum
Secondary ID [1] 292157 0
None
Universal Trial Number (UTN)
U1111-1197-3065
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 303596 0
Condition category
Condition code
Mental Health 303007 303007 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research study proposes a Randomised Controlled Trial (RCT) to assess the efficacy of a yoga-based mind-body skills training program with approximately 30 children on the Autism Spectrum (ASD) in the intervention condition and 30 children with ASD in the wait-list control condition along with one of their parents/caregivers.

The training will be run in a group format and contain 5 parent-child dyads in each group. Participants will be matched per gender given the gender-specific differences observed in children with ASD and will be randomly assigned using a computer-generated method to either the yoga-based mind-body skills training group or the wait-list control group. The participants in the intervention condition will take part in the 6-session yoga-based mind-body skills training program called "The Incredible Explorers." The program will be delivered once per week for 6 consecutive weeks at the School of Psychology, University of Queensland. Each session will be delivered face-to-face and run for around 45 minutes. Each 45-minutes session will be divided into two parts. In the first part, both parents and the children will participate and practice gentle breath-centered movements. The lead researcher and two other facilitators will deliver the program. In the second part, the parents and the children will split up into two separate groups. Whilst the children learn mindful exercises through games and activities in the children-only group with two facilitators, the parents will discuss any process issues and learn different ways to support their children with the practice outside the sessions. This group will be facilitated by the lead researcher, Radhika Tanksale.

At the end of each session, home tasks and home practice will be encouraged. The parents will be provided with a checklist to mark off the days the tasks were practised by the children during the week and will be reviewed in the next session. This checklist will assist to monitor the adherence to the intervention. A register of attendance at each session will also be maintained.

The participants in the wait-list group will wait for 12 weeks before commencing the program. This is to ensure that a controlled comparison can be done at pre, post, and 6-week follow-up.

The exercises included in the program will be simple, gentle, breath-centered mindful movement practices. The purpose of the exercises is not to improve strength, flexibility, and balance or increase heart rate, rather improve mindful attention through gentle movements. The mind-body practices will include breathing practices, mindfulness or meditation, and relaxation practices. Participants will be taught to pay mindful attention to their breath, their sensations, their feelings, and their thoughts that arise in the moment, without judgement. Examples of the some of the exercises include paying mindful attention to walking, standing tall like a mountain and being aware of the different sensations they notice with their feet touching the ground, noticing how their belly rises and falls with each breath, as well as progressive muscle relaxation. The mindfulness-based activities in the child-only group will include activities such as mindful listening of the sound of a bell.

Separate manuals for both facilitators and participants will be created to ensure consistency. Psychology interns, who will assist the lead researcher, Ms Radhika Tanksale in delivering the program will be recruited and trained in a half-day workshop and supervised by the researcher prior to the commencement of the RCT.

Assessments will be done at three different points for the intervention condition, Time 1 or pre or baseline, Time 2 or post-6-week intervention program, Time 3 or 6-week after the completion of the intervention program or follow-up and four times for the wait-list control condition Time 1,2,3 and at the end of the 6-week intervention ( time 4). The lead researcher will be supervised by Associate Professor Kate Sofronoff and Dr Jeanie Sheffield.
Intervention code [1] 298305 0
Treatment: Other
Intervention code [2] 298306 0
Lifestyle
Intervention code [3] 298307 0
Behaviour
Comparator / control treatment
30 children on the autism spectrum will comprise the wait-list control group. The wait-list control group will receive the skills training 12 weeks after the intervention group commence with the program.
Control group
Active

Outcomes
Primary outcome [1] 302380 0
The Behaviour Rating Inventory of Executive Function-Second Edition (BRIEF-2; Gioia, Isquith, Guy, & Kenworthy, 2000) (Parent form)
Timepoint [1] 302380 0
Baseline or pre-assessment (Time 1), Post-6 week intervention program (Time 2), and at 6-weeks after the completion of the intervention program or Follow-up (Time 3) for the intervention group.

Time 1, 2, 3 and Post-6 week intervention program (Time 4) for the wait-list control group.
Primary outcome [2] 302381 0
Anxiety Scale for Children- Autism Spectrum Disorder –Parent and Child version (ASC-ASD-P/C; Rodgers et al., 2016) (Parent and children forms)
Timepoint [2] 302381 0
Baseline or pre-assessment (Time 1), Post-6 week intervention program (Time 2), and at 6-weeks after the completion of the intervention program or Follow-up (Time 3) for the intervention group.

Time 1, 2, 3 and Post-6 week intervention program (Time 4) for the wait-list control group.
Primary outcome [3] 302382 0
Child Emotion Awareness Questionnaire (EAQ-30). (Rieffe, Oosterveld, Miers, Meerum Terwogt, & Ly, 2008). (Child-form)
Timepoint [3] 302382 0
Baseline or pre-assessment (Time 1), Post-6 week intervention program (Time 2), and at 6-weeks after the completion of the intervention program or Follow-up (Time 3) for the intervention group.

Time 1, 2, 3 and Post-6 week intervention program (Time 4) for the wait-list control group.
Secondary outcome [1] 335793 0
Children’s Sleep Habits Questionnaire (CSHQ; Owens, Spirito, & McGuinn, 2000) (Primary Outcome) (Parent-form)
Timepoint [1] 335793 0
Baseline or pre-assessment (Time 1), Post-6 week intervention program (Time 2), and at 6-weeks after the completion of the intervention program or Follow-up (Time 3) for the intervention group.

Time 1, 2, 3 and Post-6 week intervention program (Time 4) for the wait-list control group.
Secondary outcome [2] 335794 0
Computerised Go- No/Go test to assess sustained attention and inhibitory control. (Primary Outcome) (Children only)
Timepoint [2] 335794 0
Baseline or pre-assessment (Time 1), Post-6 week intervention program (Time 2), and at 6-weeks after the completion of the intervention program or Follow-up (Time 3) for the intervention group.

Time 1, 2, 3 and Post-6 week intervention program (Time 4) for the wait-list control group.
Secondary outcome [3] 335795 0
Goal Attainment Scale: The goal attainment scaling will be based on the guidelines by McDougall and King, 2007. One goal will be identified by the parents for their child before the training program begins. The scale will assess whether the child has attained the goal desired or identify any observed changes at the completion of the program (Time 2) and the 6-week follow up (Time 3).
Timepoint [3] 335795 0
Post-Intervention (Time 2) and 6 weeks follow-up (Time 3) for the intervention group and Post-Intervention (Time 4) for the wait-list control group.
Secondary outcome [4] 335796 0
Program satisfaction questionnaires created specifically for this program (Parent and child)
Timepoint [4] 335796 0
Post-intervention (Time 2 for intervention group and Time-4 for wait-list control group).
Secondary outcome [5] 336024 0
A computerised Flanker test to assess selective attention and response inhibition. (Primary outcome) (Child only)
Timepoint [5] 336024 0
Baseline or pre-assessment (Time 1), Post-6 week intervention program (Time 2), and at 6-weeks after the completion of the intervention program or Follow-up (Time 3) for the intervention group.

Time 1, 2, 3 and Post-6 week intervention program (Time 4) for the wait-list control group.

Eligibility
Key inclusion criteria
The study will include children with a diagnosis of Autism Spectrum Disorder (ASD) given by a Paediatrician, Psychiatrist, Clinical Psychologist, or Psychologist as per the Diagnostic and Statistical Manual, 5th Edition (DSM 5) or with a diagnosis of Asperger’s Syndrome, High-Functioning Autism or PDD-NOS made prior to 2013 as per the DSM-IV. A confirmation of the diagnosis will be requested from the parents by asking them for the name of the person who diagnosed their child, the qualifications of the person, and the date or year when the diagnosis was given. 60 children, 8-12 years of age, and who are verbally fluent will be included in the study.
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No formal diagnosis of ASD and with pre-verbal or phrase-like speech.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A mixed design will be used, with groups as the between-subjects variable and time as the within-subjects variable. Both the intervention group and the wait-list control group will receive the same mind-body skills training program. However, the wait-list group will have to wait for 12 weeks before they receive the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A Linear Mixed Model with time and group as fixed effects will be used for statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2017
Actual
21/10/2017
Date of last participant enrolment
Anticipated
8/12/2018
Actual
22/09/2018
Date of last data collection
Anticipated
31/05/2019
Actual
31/05/2019
Sample size
Target
60
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 16391 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 296736 0
University
Name [1] 296736 0
School of Psychology, University of Queensland
Country [1] 296736 0
Australia
Primary sponsor type
Individual
Name
Radhika Tanksale
Address
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 295706 0
None
Name [1] 295706 0
None
Address [1] 295706 0
None
Country [1] 295706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297919 0
School of Psychology, Ethics Review Committee
Ethics committee address [1] 297919 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Ethics committee country [1] 297919 0
Australia
Date submitted for ethics approval [1] 297919 0
12/04/2017
Approval date [1] 297919 0
20/04/2017
Ethics approval number [1] 297919 0
17-PSYCH-PHD-21-JMC

Summary
Brief summary
The present study will assess whether for children on the autism spectrum, teaching them the new skills to practice gentle breath-centered movement practices and mindful attention training based on the principles of yoga, will influence and promote their self-regulation of behavior, emotions, improve their cognitive control of executive functions, their emotion and body awareness, and benefit sleep, in those children with parent-identified sleep difficulties in the initial assessment. The study will explore the benefits of active involvement of parents in sessions, assess whether psychologists, with little or no experience in yoga, can deliver the modified, age-appropriate, user-friendly, and simple yoga-based exercises effectively as a training tool. It will examine whether a modified and manualized yoga skills training program is suitable and effective for this population and their parents and whether it can be used as an adjunct to existing treatment. 60 children on the autism spectrum between the ages of 8-12 years will be randomly assigned to either an intervention group or a wait-list control group. The intervention group will receive the 6-week yoga-based intervention program delivered once per week/6weeks. The intervention program will be delivered face-to-face by the lead researcher and two other facilitators. The wait-list control group will wait for 12 weeks before receiving the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75458 0
Ms Radhika Tanksale
Address 75458 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 75458 0
Australia
Phone 75458 0
+61452506282
Fax 75458 0
Email 75458 0
[email protected]
Contact person for public queries
Name 75459 0
Ms Radhika Tanksale
Address 75459 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 75459 0
Australia
Phone 75459 0
+61452506282
Fax 75459 0
Email 75459 0
[email protected]
Contact person for scientific queries
Name 75460 0
Ms Radhika Tanksale
Address 75460 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 75460 0
Australia
Phone 75460 0
+61452506282
Fax 75460 0
Email 75460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not provided


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.