ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Resilience

Stress

Condition category

Condition code

Mental Health

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]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Resilience level. Assessed using the Child Youth Resilience Measure (CYRM)-Youth version and the Ego Resilience Scale (ERS)

Timepoint [1]

immediately pre-post intervention

Secondary outcome [1]

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]

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Eve Skogstad

Address [1]

Unitec Institute of Technology, Private Bag 92025, Victoria Street West, Auckland 1142

Country [1]

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]

Individual

Name [1]

J. Nicholas Penney

Address [1]

Integrative Pain Care
437 Remuera Road
Auckland

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNITEC Research Ethics Committee (UREC)

Ethics committee address [1]

Unitec
Mount Albert Campus
139 Carrington road
Mount Albert
Auckland, 1025
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

06/10/2015

Approval date [1]

22/10/2015

Ethics approval number [1]

UREC Registration Number: 2015-1070

Summary

Brief summary

Mindfulness in schools programmes are increasing in use and aim to provide children and adolescents globally with the education to develop mindfulness skills (Burke, 2009; Harnett & Dawe, 2012; Zenner, Herrnleben-Kurz, & Walach, 2014). Research is, however, in its infancy for evaluating the effects of mindfulness on young people. The number of studies are growing, but the enthusiasm of the delivery of programmes currently exceeds the evidence for their effectiveness (Greenberg & Harris, 2012).

A range of outcome effects of mindfulness training on children and adolescents research have evaluated cognitive performance (Semple, Lee, Rosa, & Miller, 2010), emotional regulation (Broderick & Metz, 2009), well-being (Hennelly, 2011; Huppert & Johnson, 2010), depression (Biegel, Brown, Shapiro, & Schubert, 2009), and blood pressure (Gregoski, Barnes, Tingen, Harshfield, & Treiber, 2011). Further research to evaluate specific outcomes may be beneficial to gain a richer understanding of the effects of mindfulness in schools programmes for children and adolescents. Therefore this study aims to evaluate resilience as an outcome measure specifically, to help establish a greater understanding of effects of this education and training with children. 

Resilience is an important process that helps in dealing with disruptive, stressful, or challenging life events, in a way that provides the individual with additional protective and coping skills. The development of children and youth to overcome challenging situations, can be assisted by encouraging characteristics of efficacy, self-esteem and perseverance (Lerner, Brentano, Dowling, & Anderson, 2002).

This study aims to evaluate whether resilience can be increased by learning mindfulness techniques so that in the face of challenge or adversity, the involvement of awareness and control of thoughts and feelings are active, and positive relationships that encompass empathy and kindness are fostered (Hennelly, 2011; Huppert & Johnson, 2010). Beneficial results from this study, in collaboration with similar studies globally, may encourage and strengthen the use 
of mindfulness teaching in the mainstream education system in New Zealand and globally.

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 design will employ a quantitative approach using current child specific resilience survey tools the Child Youth Resilience Measure (CYRM) and the Ego Resilience Scale (ERS) pre and post  completion of the course.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/370712-2015-1070 Application approval letter.pdf

Contacts

Principal investigator

Name

Miss Eve Skogstad

Address

Unitec Institute of Technology, Private Bag 92025, Victoria Street West, Auckland 1142

Country

New Zealand

Phone

+64 27 550 6466

Fax

eve-nz@windowslive.com

Contact person for public queries

Name

Eve Skogstad

Address

Unitec Institute of Technology, Private Bag 92025, Victoria Street West, Auckland 1142

Country

New Zealand

Phone

+64 27 550 6466

Fax

eve-nz@windowslive.com

Contact person for scientific queries

Name

Dr Elizabeth Niven

Address

Unitec Institute of Technology, Private Bag 92025, Victoria Street West, Auckland 1142

Country

New Zealand

Phone

+64 21 654935

Fax

eniven@unitec.ac.nz

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically