Trial Review

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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] 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, 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)
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
Recruitment postcode(s) [4] 29208 0
5064 - Glenunga

Funding & Sponsors
Funding source category [1] 295988 0
University
Name [1] 295988 0
Flinders University
Country [1] 295988 0
Australia
Funding source category [2] 296056 0
Other Collaborative groups
Name [2] 296056 0
Fraser Mustard Centre
Country [2] 296056 0
Australia
Funding source category [3] 304863 0
Charities/Societies/Foundations
Name [3] 304863 0
Channel Seven Childrens' Research Foundation
Country [3] 304863 0
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] 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
Secondary sponsor category [2] 305202 0
University
Name [2] 305202 0
Flinders University
Address [2] 305202 0
GPO Box 2100
Adelaide SA 5001
Country [2] 305202 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
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
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
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 73462 0
+618 8201 5122
Fax 73462 0
Email 73462 0
[email protected]
Contact person for public queries
Name 73463 0
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
[email protected]
Contact person for scientific queries
Name 73464 0
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
[email protected]

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: [email protected] (or [email protected])


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.