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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
31/03/2017
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
None
Universal Trial Number (UTN)
U1111-1194-5055
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
Depression
Mental Health 302100 302100 0 0
Anxiety
Mental Health 302101 302101 0 0
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] 297630 0
Prevention
Intervention code [2] 297654 0
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] 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, 6 month and 12 month follow up

Eligibility
Key inclusion criteria
enrolled a selected school in Year 8, 10 or 12, with passive consent from parent and active assent from student
Minimum age
12 Years
Maximum age
18 Years
Gender
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
This is a pilot study based on timetabling availability within schools; may not meet ideal power analyses of 90 subjects per group.
Three year levels (Year 8, 10, 12) by two groups (control, mindfulness) = 6 groups @90 subjects

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
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

Funding & Sponsors
Funding source category [1] 295988 0
University
Name [1] 295988 0
Flinders University
Address [1] 295988 0
GPO Box 2100
Adelaide SA 5001
Country [1] 295988 0
Australia
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
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
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
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 297250 0
30/01/2017
Approval date [1] 297250 0
31/01/2017
Ethics approval number [1] 297250 0
6534
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
Australia
Date submitted for ethics approval [2] 297313 0
03/02/2017
Approval date [2] 297313 0
28/03/2017
Ethics approval number [2] 297313 0
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 73462 0
Ms Catherine Johnson
Address 73462 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 73462 0
Australia
Phone 73462 0
+618 8201 5122
Fax 73462 0
Email 73462 0
catherine.johnson@flinders.edu.au
Contact person for public queries
Name 73463 0
Ms Catherine Johnson
Address 73463 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 73463 0
Australia
Phone 73463 0
+618 8201 5122
Fax 73463 0
Email 73463 0
catherine.johnson@flinders.edu.au
Contact person for scientific queries
Name 73464 0
Ms Catherine Johnson
Address 73464 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 73464 0
Australia
Phone 73464 0
+618 8201 5122
Fax 73464 0
Email 73464 0
catherine.johnson@flinders.edu.au

No data has been provided for results reporting
Summary results
Not applicable