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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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] 291501 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 302574 0
Anxiety 302575 0
Eating disorders 302576 0
Condition category
Condition code
Mental Health 302099 302099 0 0
Mental Health 302100 302100 0 0
Mental Health 302101 302101 0 0
Eating disorders

Study type
Description of intervention(s) / exposure
Adolescent mindfulness intervention: Mindful Teens (advance English translation from developer; 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] 297630 0
Intervention code [2] 297654 0
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

Primary outcome [1] 301599 0
Depression (DASS-21 subscale and CES-DC)
Timepoint [1] 301599 0
Three weeks prior to intervention, one week post intervention, 6 month and 12 month follow up
Primary outcome [2] 301600 0
Anxiety (DASS-21 subscale and GAD-7
Timepoint [2] 301600 0
Three weeks prior to intervention, one week post intervention, 6 month and 12 month follow up
Primary outcome [3] 301601 0
weight and shape concerns (subscales of EDE-Q)
Timepoint [3] 301601 0
Three weeks prior to intervention, one week post intervention, 6 month and 12 month follow up
Secondary outcome [1] 333273 0
mindfulness (eight subscales of CHIME-A)
Timepoint [1] 333273 0
Three weeks prior to intervention, one week post intervention, 3-6 month follow-up.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 15667 0
5063 - Highgate
Recruitment postcode(s) [2] 15668 0
5162 - Morphett Vale
Recruitment postcode(s) [3] 15669 0
5171 - Mclaren Vale
Recruitment postcode(s) [4] 29208 0
5064 - Glenunga

Funding & Sponsors
Funding source category [1] 295988 0
Name [1] 295988 0
Flinders University
Address [1] 295988 0
GPO Box 2100
Adelaide SA 5001
Country [1] 295988 0
Funding source category [2] 296056 0
Other Collaborative groups
Name [2] 296056 0
Fraser Mustard Centre
Address [2] 296056 0
Level 8, 31 Flinders Street
Adelaide, SA, 5000
Country [2] 296056 0
Funding source category [3] 304863 0
Name [3] 304863 0
Channel Seven Childrens' Research Foundation
Address [3] 304863 0
171 Days Rd, Regency Park SA 5010
Country [3] 304863 0
Primary sponsor type
Channel Seven Childrens' Research Foundation
171 Days Rd, Regency Park SA 5010
Secondary sponsor category [1] 294875 0
Other Collaborative groups
Name [1] 294875 0
Fraser Mustard Centre
Address [1] 294875 0
Level 8, 31 Flinders Street
Adelaide, SA, 5000
Country [1] 294875 0
Secondary sponsor category [2] 305202 0
Name [2] 305202 0
Flinders University
Address [2] 305202 0
GPO Box 2100
Adelaide SA 5001
Country [2] 305202 0

Ethics approval
Ethics application status
Ethics committee name [1] 297250 0
Social and Behavioural Sciences Research Ethics Committee, Flinders University
Ethics committee address [1] 297250 0
GPO Box 2100
Adelaide SA 5001
Ethics committee country [1] 297250 0
Date submitted for ethics approval [1] 297250 0
Approval date [1] 297250 0
Ethics approval number [1] 297250 0
Ethics committee name [2] 297313 0
SA Department of Education and Child Development
Ethics committee address [2] 297313 0
Level 8, 31 Flinders Street
Adelaide, SA 5000
Ethics committee country [2] 297313 0
Date submitted for ethics approval [2] 297313 0
Approval date [2] 297313 0
Ethics approval number [2] 297313 0
CS/17/000747 1.1

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
Trial related presentations / publications
Public notes

Principal investigator
Name 73462 0
Dr Catherine Johnson
Address 73462 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 73462 0
Phone 73462 0
+618 8201 5122
Fax 73462 0
Email 73462 0
Contact person for public queries
Name 73463 0
Dr Catherine Johnson
Address 73463 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 73463 0
Phone 73463 0
+618 8201 5122
Fax 73463 0
Email 73463 0
Contact person for scientific queries
Name 73464 0
Dr Catherine Johnson
Address 73464 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 73464 0
Phone 73464 0
+618 8201 5122
Fax 73464 0
Email 73464 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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: (or
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary