Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000729729
Ethics application status
Approved
Date submitted
11/06/2013
Date registered
2/07/2013
Date last updated
16/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
MiYoga: Mindfulness Yoga for Children with Cerebral Palsy
Scientific title
MiYoga: A Randomised Controlled Trial of a Mindfulness Yoga Program for enhancing sustained attention in Children with Cerebral Palsy
Secondary ID [1] 281128 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MiYoga
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 287299 0
Condition category
Condition code
Mental Health 287629 287629 0 0
Studies of normal psychology, cognitive function and behaviour
Physical Medicine / Rehabilitation 287630 287630 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a randomised waitlist control design.

Participants in both groups will receive the Mindfulness Yoga (MiYoga) intervention which aims to teach both children and parent/guardians mindfulness skills (ability to focus attention on the present moment without judgement). Through mindfulness practices, this MiYoga aims to enhance attention, physical and behavioural outcomes in children with cerebral palsy while at the same time aiming to improve parent's psychological flexibility, parent-child relationship and reduce stress. This program will be conducted as a group program with 5-8 child-parent diads per group. 6 group sessions running for 90 minutes each will be offered once weekly for six weeks, with an additional 20 minutes daily home practice with a MiYoga DVD in between group sessions. The total length of the program is 25+ hours (including 20 minutes daily home practice) over 8 weeks.
Intervention code [1] 285586 0
Behaviour
Intervention code [2] 285587 0
Rehabilitation
Comparator / control treatment
The treatment group will be compared to a wait-list control group, who will receive the MiYoga intervention once the treatment group has completed their intervention.
Control group
Active

Outcomes
Primary outcome [1] 289212 0
Sustained attention: Conner’s Continuous Performance Test (CPT; Conners, 2000)
Timepoint [1] 289212 0
Baseline, post-intervention and follow up
Primary outcome [2] 289898 0
Child and Adolescent Mindfulness Measure (CAMM; Greco, Baer & Smith, 2011)
Timepoint [2] 289898 0
Baseline, post-intervention and follow up
Primary outcome [3] 289899 0
Mindfulness Attention Awareness Scale (MASS; Brown and Ryan 2003)
Timepoint [3] 289899 0
Baseline, post-intervention and follow up
Secondary outcome [1] 302053 0
Symbol Search from the WISC-IV (Wechsler, 2004).
Timepoint [1] 302053 0
Baseline, post-intervention and follow up
Secondary outcome [2] 303150 0
Digit Span Backward from the WISC-IV (Wechsler, 2004)
Timepoint [2] 303150 0
Baseline, post-intervention and follow up
Secondary outcome [3] 303151 0
Trail Making Test (D-KEFS; Delis et al., 2001)
Timepoint [3] 303151 0
Baseline, post-intervention and follow up
Secondary outcome [4] 303546 0
Colour-Word Interference (D-KEFS; Delis et al., 2001)
Timepoint [4] 303546 0
Baseline, post-intervention and follow up
Secondary outcome [5] 303547 0
Sit and reach test (reach distance)
Timepoint [5] 303547 0
Baseline, post-intervention and follow up
Secondary outcome [6] 303548 0
Lateral Step-up (Verschuren et al., 2008)
Timepoint [6] 303548 0
Baseline, post-intervention and follow up
Secondary outcome [7] 303549 0
Half kneel to stand (Verschuren et al., 2008)
Timepoint [7] 303549 0
Baseline, post-intervention and follow up
Secondary outcome [8] 303550 0
6-minute walk test (6MWT)
Timepoint [8] 303550 0
Baseline, post-intervention and follow up
Secondary outcome [9] 303551 0
CP QOL-Child (Waters et al., 2006)
Timepoint [9] 303551 0
Baseline, post-intervention and follow up
Secondary outcome [10] 303553 0
MobQues47
Timepoint [10] 303553 0
Baseline, post-intervention and follow up
Secondary outcome [11] 303554 0
Behavior Rating Inventory of Executive Function (BRIEF; Gioia et al., 2000)
Timepoint [11] 303554 0
Baseline, post-intervention and follow up
Secondary outcome [12] 303555 0
Acceptance and Action Questionnaire (AAQ-II, Bond et al., 2011)
Timepoint [12] 303555 0
Baseline, post-intervention and follow up
Secondary outcome [13] 303556 0
Depression Anxiety Stress Scale (DASS) (Lovibond & Lovibond, 1995)
Timepoint [13] 303556 0
Baseline, post-intervention and follow up
Secondary outcome [14] 303557 0
Personal Wellbeing Index – Adult (PWI-A; International Wellbeing Group, 2006)
Timepoint [14] 303557 0
Baseline, post-intervention and follow up
Secondary outcome [15] 303558 0
Child–Parent Relationship Scale (CPRS; Driscoll & Pianta, 2001)
Timepoint [15] 303558 0
Baseline, post-intervention and follow up

Eligibility
Key inclusion criteria
Participants are children (aged between 8 and 16 at the point of recruitment) with a diagnosis of CP with spastic motor type, diplegia motor distribution and a GMFCS I-III. Children must also have sufficient co-operation and cognitive understanding to follow simple instructions. The primary caregiver of eligible children will participate alongside their child. Children with comorbid diagnoses to CP are included.

Diagnosis of CP must be confirmed by the treating paediatrician or clinician and in accordance with published recommendations.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded if they have (i) received upper-limb or lower-limb surgery in the previous 6 months; (ii) unstable epilepsy (i.e. frequent seizures not controlled by medication); (iii) spinal instability or other spinal problems that would prevent them from participating safely in the MiYoga program; (iv) have a medical condition that would prevent them from participating safely in the MiYoga program; or (v) parents/guardians who are pregnant as a safety precaution.

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)
A waitlist randomised control trial, where Children with mild to moderate CP are randomised via a computergenerated random number table to either receive MiYoga immediately or be waitlisted for a 8 week period and then commence MiYoga. Allocations will be placed in concealed envelopes, held and opened after initial baseline measurement to either
Immediate intervention group or the delayed intervention group (waitlist control).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be computer-generated. Treatment allocations will be recorded on pieces of paper, which will be folded and placed inside sealed, numbered, opaque envelopes by a staff member not involved in the study. Envelopes will be opened by the study coordinator in order as each participant returns their questionnaires. Given the nature of the study, no parties will be blinded to group assignment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Waitlist Control
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
It was documented that the reaction time of children with CP was two standard deviations below healthy controls on the Continuous Performance Test (CPT) (Lemay et al., 2012). This study is interested in detecting a difference of one standard deviation between the treatment and control group at Time 2 (post-intervention) to determine the clinical significance of the MiYoga program. Based on Lehr's equation with alpha set at 0.05 and power set at 0.80, to detect a difference of one standard deviation between groups, a sample size of 16 participants per group would be needed (Lehr, 1992). If a retention rate of 90% is assumed, a total of 36 children will need to be recruited.

Analysis will follow standard principles for RCTs, using two-group comparisons on all participants on an intention-to-treat basis. External and internal validity of results will be checked using baseline and general descriptive information available for all eligible families; comparing the characteristics of families who completed the study with those who enrolled in the study but did not complete, and those who did not enroll. The primary comparison immediately post intervention (8 weeks) will be scores from the Continuous Performance Test.

Analysis will follow standard methods for randomised controlled trials using comparisons between the two groups (MiYoga and wait-list control). The protocol of intention-to-treat analysis will be followed in order to minimise inflation of treatment effects consistent with CONSORT guidelines. The experimental unit will be the child and their participating primary caregiver. Attrition analysis will be conducted. Data will be analysed using SPSS and Stata.

The hypotheses relating to intervention efficacy will be tested using general linear models, specifically via ANCOVA. In addition, predictors of treatment outcome will be explored using regression analyses. In particular, which child or parent benefited from MiYoga. It is hypothesized that children with the most difficulties regulating their attention as measured on CPT, and WISC-IV and D-KEFS subtests and parents experiencing low levels of mindfulness as measured by the MAAS and high levels of psychological symptoms as measured on the DASS will benefit most from MiYoga.

Non-parametric methods will be used for simple comparisons in cases where continuous data exhibit substantial skewness not overcome by transformation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/07/2013
Actual
3/09/2013
Date of last participant enrolment
Anticipated
31/10/2014
Actual
23/09/2015
Date of last data collection
Anticipated
31/10/2016
Actual
24/02/2017
Sample size
Target
36
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 833 0
Royal Children's Hospital - Herston
Recruitment hospital [2] 6144 0
Lady Cilento Children's Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 286991 0
University
Name [1] 286991 0
The University of Queensland
Country [1] 286991 0
Australia
Primary sponsor type
University
Name
The University of Queensland - School of Psychology
Address
Sir Fred Schonell Dr, St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 285780 0
University
Name [1] 285780 0
The University of Queensland - School of Medicine, Queensland Cerebral Palsy and Rehabilitation Research Centre
Address [1] 285780 0
Herston Road, Herston, Brisbane, QLD 4029
Country [1] 285780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289519 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 289519 0
Ethics committee country [1] 289519 0
Australia
Date submitted for ethics approval [1] 289519 0
16/07/2012
Approval date [1] 289519 0
21/08/2012
Ethics approval number [1] 289519 0
HREC/12/QRCH/120
Ethics committee name [2] 289520 0
The University of Queensland Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [2] 289520 0
Ethics committee country [2] 289520 0
Australia
Date submitted for ethics approval [2] 289520 0
03/09/2012
Approval date [2] 289520 0
06/09/2012
Ethics approval number [2] 289520 0
2012000993

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34644 0
Ms Catherine Mak
Address 34644 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC)
Level 6, Centre for Children’s Health Research
62 Graham Street, South Brisbane, QLD 4101
Country 34644 0
Australia
Phone 34644 0
+61 7 3069 73560
Fax 34644 0
Email 34644 0
[email protected]
Contact person for public queries
Name 17891 0
Catherine Mak
Address 17891 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC)
Level 6, Centre for Children’s Health Research
62 Graham Street, South Brisbane, QLD 4101
Country 17891 0
Australia
Phone 17891 0
+61 7 3069 73560
Fax 17891 0
Email 17891 0
[email protected]
Contact person for scientific queries
Name 8819 0
Catherine Mak
Address 8819 0
Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC)
Level 6, Centre for Children’s Health Research
62 Graham Street, South Brisbane, QLD 4101
Country 8819 0
Australia
Phone 8819 0
+61 7 3069 73560
Fax 8819 0
Email 8819 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMiYoga: A randomised controlled trial of a mindfulness movement programme based on hatha yoga principles for children with cerebral palsy: A study protocol.2017https://dx.doi.org/10.1136/bmjopen-2016-015191
EmbaseEffect of mindfulness yoga programme MiYoga on attention, behaviour, and physical outcomes in cerebral palsy: a randomized controlled trial.2018https://dx.doi.org/10.1111/dmcn.13923
N.B. These documents automatically identified may not have been verified by the study sponsor.