Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001123437
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
18/08/2016
Date last updated
18/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot evaluation on the efficacy of a universal school-based mindfulness intervention to enhance resilience in children
Scientific title
A pilot evaluation on the efficacy of a universal school-based mindfulness intervention to enhance resilience in children
Secondary ID [1] 289234 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resilience 298803 0
Stress 298804 0
Condition category
Condition code
Mental Health 298850 298850 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to advance the understanding of the effects of mindfulness training on 11-12 year old children by administering a mindfulness-training course, the globally established nine-week ‘.b’ (dot be) programme developed in England, taught in a New Zealand school context, measuring resilience as the variable pre- and post-intervention, and comparing changes in resilience within the class.

The ‘.b’ course is a nine-week programme that follows a teaching outline taught once a week for 30minutes :

Lesson One: Direct attention: Paying attention- Training the muscle of your mind
Skills-Directing your attention, Exploring and investigating what you find
Practices- ‘Aiming and sustaining’ attention on breathing for 2 minutes, Counting the number of breaths in a minute
Lesson Two: Accept and Calm: Taming the animal mind- Cultivating curiosity and kindness
Skills- Calming the mind by ‘anchoring’ it in the body, Relaxing and breathing with experiences, even difficult ones
Practices- FOFBOC: A body scan with Feet on Floor, Bum on Chair, Anchoring your mind in the sensations of the body
Lesson Three: Deal with worry: Recognise worry- Noticing how your mind plays tricks on you
Skills- Recognising what our minds do that makes us worry: we Interpret, we ruminate, we catastrophise,‘Un-worrying’ via a 7/11, Using beditation to help us sleep
Practices- 7-11, Beditation (lying down body scan)
Lesson Four: Be here now- From reacting to responding
Skills- Stepping out of ‘auto-pilot’ mode, Savouring the pleasant, Responding to the unpleasant rather than reacting
Practices- .b, Mindful mouthful, Siting like a statue for 15 minutes
Lesson Five: Move mindfully- Moving Mindfully
Skills: Moving mindfully, Bringing mindfulness to daily activity, Aspiring to ‘flow’ or be ‘in the zone’
Practices: Mindful Walking, Mindful toothbrushing, Showering, eating etc.
Lesson Six: Step back- Stepping back: Watching the though-traffic of your mind Skills: Seeing thoughts as traffic that flows through the mind, Identifying ‘thought-buses’ that pass through your mind, Recognising that you don’t have to ‘get on the bus’ of difficult thoughts
Practices: Observing thought-traffic, Practising staying at the bus stop, rather than getting taken for a ride
Lesson Seven: Befriend the difficult- Befriending the difficult
Skill: Understanding stress, Recognising your stress signature, Responding to stress and difficult emotions rather than reacting to them
Practices: Breathing with stress/ letting it be
Lesson Eight: Take in the Good- Taking in the good: Being present with your heart
Skills: Appreciation of what is good in life, Recognising how even the ordinary can be experienced as ‘good’ if we are more fully aware of it
Practices: ‘Taking in the good’- Gratitude Practice
Lesson Nine: Pulling it all together
Revision: What have you found most useful? In what ways do these skills help change your life for the better? What advice would you give yourself to make the most of what you have learned?

Taught by Dr Nick Penney, a .b mindfulness teacher of two years, with a background in adult mindfulness training for three years,
The course is taught within school hours timetabled into the curriculum, each class lasts 30minutes and is conducted in the school classroom.
Intervention code [1] 294770 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298328 0
Resilience level. Assessed using the Child Youth Resilience Measure (CYRM)-Youth version and the Ego Resilience Scale (ERS)
Timepoint [1] 298328 0
immediately pre-post intervention
Secondary outcome [1] 323853 0
Child and Youth Resilience Measure (CYRM) tool sensitivity to a .b programme by correlation with the gold standard measure, the Ego Resilience Scale (ERS).
Timepoint [1] 323853 0
immediately pre-post intervention

Eligibility
Key inclusion criteria
*Enrolled in the school
*Appropriate permission granted by under 16 years of age participants
*Completion of both the pre and post survey results, with a minimum of 50% attendance in the mindfulness classes in the nine-week program. Previous mindfulness research with children has suggested noticeable changes in this time and many research papers have included a similar criteria.
*English reading competency matching the level of the surveys, established by the class teacher.
Minimum age
11 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parental or student refusal for the mindfulness class or for the research.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Considering this is a preliminary exploratory study, a non-probability method of convenience sampling will be used. This will be based on the convenience of sampling according to the PPTA website stating one average class in New Zealand has 25 pupils, but most frequently class sizes are of 28 students, to gain an approximation of the representation of this population (http://www.ppta.org.nz/issues/class-size).

An estimated sample of 140 participants from the year group, consisting of 5 year eight classes, will be recruited,



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/02/2016
Date of last participant enrolment
Anticipated
Actual
4/03/2016
Date of last data collection
Anticipated
15/04/2016
Actual
25/04/2016
Sample size
Target
140
Accrual to date
Final
103
Recruitment outside Australia
Country [1] 7879 0
New Zealand
State/province [1] 7879 0
Auckland

Funding & Sponsors
Funding source category [1] 294325 0
Self funded/Unfunded
Name [1] 294325 0
Eve Skogstad
Country [1] 294325 0
New Zealand
Primary sponsor type
Individual
Name
Eve Skogstad
Address
Unitec Institute of Technology, Private Bag 92025, Victoria Street West, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 293163 0
Individual
Name [1] 293163 0
J. Nicholas Penney
Address [1] 293163 0
Integrative Pain Care
437 Remuera Road
Auckland
Country [1] 293163 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295044 0
UNITEC Research Ethics Committee (UREC)
Ethics committee address [1] 295044 0
Ethics committee country [1] 295044 0
New Zealand
Date submitted for ethics approval [1] 295044 0
06/10/2015
Approval date [1] 295044 0
22/10/2015
Ethics approval number [1] 295044 0
UREC Registration Number: 2015-1070

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 881 881 0 0
/AnzctrAttachments/370712-2015-1070 Application approval letter.pdf

Contacts
Principal investigator
Name 65906 0
Miss Eve Skogstad
Address 65906 0
Unitec Institute of Technology, Private Bag 92025, Victoria Street West, Auckland 1142
Country 65906 0
New Zealand
Phone 65906 0
+64 27 550 6466
Fax 65906 0
Email 65906 0
[email protected]
Contact person for public queries
Name 65907 0
Eve Skogstad
Address 65907 0
Unitec Institute of Technology, Private Bag 92025, Victoria Street West, Auckland 1142
Country 65907 0
New Zealand
Phone 65907 0
+64 27 550 6466
Fax 65907 0
Email 65907 0
[email protected]
Contact person for scientific queries
Name 65908 0
Dr Elizabeth Niven
Address 65908 0
Unitec Institute of Technology, Private Bag 92025, Victoria Street West, Auckland 1142
Country 65908 0
New Zealand
Phone 65908 0
+64 21 654935
Fax 65908 0
Email 65908 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
No additional documents have been identified.