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Trial registered on ANZCTR

Registration number

ACTRN12617000471381

Ethics application status

Approved

Date submitted

28/03/2017

Date registered

31/03/2017

Date last updated

10/11/2021

Date data sharing statement initially provided

4/02/2020

Date results provided

10/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Is a schools-based 8-week mindfulness programme more effective for younger versus older adolescents?

Scientific title

Is a schools-based 8-week mindfulness programme more effective for transdiagnostic prevention in younger versus older adolescents?

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1194-5055

Trial acronym

Linked study record

Health condition

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

Depression

Anxiety

Eating disorders

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

Eating disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Adolescent mindfulness intervention: Mindful Teens (advance English translation from developer http://daviddewulf.be/en/mindfulness-for-life; also see Raes, F., Griffith, J., Van der Gucht, K., & Williams, J. (2014). School-based prevention and Reduction of Depression in Adolescents: A Cluster-Randomized Trial of a Mindfulness Group Program. Mindfulness, 5(5), 477-486. ).
Lesson duration 75- 100 minutes delivered face to face to school classes (Year 8, 10, 12) once weekly over a period of 8 weeks. Lesson length varies per school depending on the length of a standard double lesson. Attendance at lessons is recorded by classroom teacher. Lesson format is a mix of mindfulness meditation, real-life applications, interactive activities and discussion. Students will receive a weekly handout with key messages and home activities. Home activities consist of (1) daily tips to apply short mindfulness strategies (a few minutes) (2) Formal guided meditations with an audioCD (building from 10 to 20 minutes with an invitation to listen daily) (3) exploration exercises eg noting thoughts and feelings associated with pleasant and unpleasant events (5-15 minutes over a week). Students self-report their home practice compliance in deidentified survey post course. Delivered by an external facilitator (15 years personal mindfulness experience, adult and youth mindfulness facilitator) with classroom teacher present. Classes will be audiorecorded and rated for competence and fidelity by programme developer.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

Lessons as usual. Lessons have been scheduled in pastoral care time, science, health and physical education as chosen by each school.

Control group

Active

Outcomes

Primary outcome [1]

Depression (DASS-21 subscale and CES-DC)

Timepoint [1]

Three weeks prior to intervention, one week post intervention, 6 month and 12 month follow up

Primary outcome [2]

Anxiety (DASS-21 subscale and GAD-7

Timepoint [2]

Three weeks prior to intervention, one week post intervention, 6 month and 12 month follow up

Primary outcome [3]

weight and shape concerns (subscales of EDE-Q)

Timepoint [3]

Three weeks prior to intervention, one week post intervention, 6 month and 12 month follow up

Secondary outcome [1]

mindfulness (eight subscales of CHIME-A)

Timepoint [1]

Three weeks prior to intervention, one week post intervention, 3-6 month follow-up.

Eligibility

Key inclusion criteria

Enrolled a selected school in Year 8, 10 or senior group 11/12, with passive consent from parent and active assent from student

Minimum age

12 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Nil

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Yes. Schools nominated pairs of classes to take part which were then randomly allocated to intervention/control offsite by the main researcher..

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

excel randomisation, with a priori rules regarding allocation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Power analysis: Three year levels (Year 8, 10, 11/12) by two groups (control, mindfulness) = 6 groups @ 90 subjects per group (Total N = 540).
Pilot study in 2017 underpowered (Total N = 90); collecting more data in 2018 for Year 8, 10 and Year 11/12 students to meet power requirements. Data for the initial pilot study underwent preliminary analysis, but will be included in the final dataset.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/04/2017

Actual

4/04/2017

Date of last participant enrolment

Anticipated

30/06/2017

Actual

4/02/2019

Date of last data collection

Anticipated

30/06/2018

Actual

1/07/2019

Sample size

Target

540

Accrual to date

Final

434

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5063 - Highgate

Recruitment postcode(s) [2]

5162 - Morphett Vale

Recruitment postcode(s) [3]

5171 - Mclaren Vale

Recruitment postcode(s) [4]

5064 - Glenunga

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

GPO Box 2100
Adelaide SA 5001

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Fraser Mustard Centre

Address [2]

Level 8, 31 Flinders Street
Adelaide, SA, 5000

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Channel Seven Childrens' Research Foundation

Address [3]

171 Days Rd, Regency Park SA 5010

Country [3]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Channel Seven Childrens' Research Foundation

Address

171 Days Rd, Regency Park SA 5010

Country

Australia

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

Fraser Mustard Centre

Address [1]

Level 8, 31 Flinders Street
Adelaide, SA, 5000

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

Flinders University

Address [2]

GPO Box 2100
Adelaide SA 5001

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Social and Behavioural Sciences Research Ethics Committee, Flinders University

Ethics committee address [1]

GPO Box 2100
Adelaide SA 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/01/2017

Approval date [1]

31/01/2017

Ethics approval number [1]

6534

Ethics committee name [2]

SA Department of Education and Child Development

Ethics committee address [2]

Level 8, 31 Flinders Street
Adelaide, SA 5000

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

03/02/2017

Approval date [2]

28/03/2017

Ethics approval number [2]

CS/17/000747 1.1

Summary

Brief summary

An initial RCT undertaken by us in 2014 (N = 308) and a follow-up RCT undertaken in 2015-2016 (N = 557) investigated mindfulness with Year 8 students in Adelaide schools. We used a UK based 9-week mindfulness curriculum with lessons once per week (40-60 minutes). Surprisingly, we were unable to replicate promising findings from a controlled (but not randomised) trial using this programme (Kuyken et al., 2013) which found improvements in wellbeing, stress and depression that lasted for 3 months following the intervention. 

Our pilot trial has been published (Johnson, Burke, Brinkman and Wade, 2016) and the larger follow-up trial is currently under review. We hypothesised that the programme might have been too brief for the ideas to sink in, and that there might not have been enough practice in class of the meditations, relying too much on home practice (which was invitational). We also wondered if Year 8s might be too young to appreciate the relevance of these emotional tools given that they hadn't yet hit some of the increased stresses and strains of mid-late adolescence. 
 
Therefore, we are testing these ideas in the current RCT 

We will substitute an alternative, Belgian programme, which recently found both treatment and prevention effects for depression which lasted for 6 months in adolescents aged 13-20 in a school setting (Raes et al., 2014). This programme, which has just been translated into English, runs for a similar number of weeks (8) but has longer lessons (75-100 minutes weekly) allowing more time for guided practice in class (rather than relying on home practice), plus expanded opportunities for discussion and application to real-life scenarios. We will test this across three age groups (Year 8, mean age 13.5;Year 10, mean age 15.5; Year 12, mean age 17.5) to expand our investigation into whether the mindfulness approach operates differently within adolescent age bands. This will have direct relevance for where to insert these curricula in the school journey for maximum effect. 

Research Objectives
1.	To examine the efficacy of an alternative curriculum (Mindfulness for Teens) on anxiety, depression, eating disorder risk factors, wellbeing and different facets of mindfulness
2.	To investigate whether age affects these outcomes (i.e., are mindfulness programmes more effective at certain ages during adolescence?)
3.	To investigate whether mindfulness programmes operate via different mechanisms
according to stage of neurocognitive development (i.e., do we need to emphasise different components at different ages?)

Trial website

N/A

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Catherine Johnson

Address

School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001

Country

Australia

Phone

+618 8201 5122

Fax

catherine.johnson@flinders.edu.au

Contact person for public queries

Name

Catherine Johnson

Address

School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001

Country

Australia

Phone

+618 8201 5122

Fax

catherine.johnson@flinders.edu.au

Contact person for scientific queries

Name

Catherine Johnson

Address

School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001

Country

Australia

Phone

+618 8201 5122

Fax

catherine.johnson@flinders.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All deidentified group data will be available

When will data be available (start and end dates)?

Immediately on publication and then for 5 years

Available to whom?

Researchers with a methodologically sound proposal

Available for what types of analyses?

Any methodologically sound analyses

How or where can data be obtained?

Via email to research team: catherine.johnson@flinders.edu.au (or Tracey.wade@flinders.edu.au)

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.

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