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Trial registered on ANZCTR


Registration number
ACTRN12615001052527
Ethics application status
Approved
Date submitted
19/02/2015
Date registered
7/10/2015
Date last updated
9/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison in early high school students of the effect of an 8 week course of mindfulness (with and without parental involvement) versus normal school lessons on anxiety, depression, eating disorder risk factors and wellbeing
Scientific title
A randomised controlled trial of a the ".b" mindfulness in schools curriculum (standard version) versus a modified version (with parental involvement) versus normal lessons in Year 8 male and female Australian students to assess impact on anxiety, depression, weight/shape concerns and wellbeing (primary outcome factors) and mindfulness (secondary outcome factor).
Secondary ID [1] 286215 0
Nil
Universal Trial Number (UTN)
U1111-1157-3112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 294261 0
Anxiety 294262 0
Eating disorders 294263 0
Wellbeing 294264 0
Condition category
Condition code
Mental Health 294578 294578 0 0
Depression
Mental Health 294579 294579 0 0
Anxiety
Mental Health 294580 294580 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescent mindfulness intervention (.b mindfulness in schools programme). Lesson duration 40-60 minutes delivered once weekly over a period of 8 weeks. Lesson format is a mix of interactive activities, short talks and mindfulness practices. Topics include training attention, cultivating a curious, patient and friendly attitude towards experience, understanding worry, switching out of autopilot back to the present moment, learning to step back from thoughts and befriend difficult emotions, and applying mindfulness to movement. Delivered by external mindfulness teacher. A standard version of the curriculum and a modified version, with parental involvement, will be delivered and compared to a control group. The "Parental Enhanced" mindfulness group will receive the following additions: a one hour information session for parents before the trial commences, and access to a weekly you-tube clip (approx. ten minutes) that descibes the key points of the lesson and the mindfulness practices to encourage discussion with child, reinforcement of importance of homework practice, and perhaps undertaking the practices at home together. No formal adherence checks will be undertaken.
Intervention code [1] 291234 0
Prevention
Intervention code [2] 291288 0
Behaviour
Comparator / control treatment
Lessons as usual
Control group
Active

Outcomes
Primary outcome [1] 294347 0
Depression and anxiety subscale scores, and total negative affect score on DASS-21
Timepoint [1] 294347 0
two weeks prior to intervention, one week post intervention, 5 month and twelve month follow up
Primary outcome [2] 294348 0
Weight and shape concerns subscales of the Eating Disorders Examination Questionnaire
Timepoint [2] 294348 0
two weeks prior to intervention, one week post intervention, 5 month and twelve month follow up
Primary outcome [3] 294349 0
Wellbeing (Warwick Edinburgh Mental Wellbeing Scale)
Timepoint [3] 294349 0
two weeks prior to intervention, one week post intervention, 5 month and twelve month follow up
Secondary outcome [1] 313077 0
Mindfulness (CHIME-youth multifactor questionnaire)
Timepoint [1] 313077 0
two weeks prior to intervention, one week post intervention, 5 month and twelve month follow up

Eligibility
Key inclusion criteria
enrolled at selected school in Year 8, with passive consent from parent and active assent from student
Minimum age
11 Years
Maximum age
16 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)
Selected schools provide trios of classes which are randomly allocated to intervention (mindfulness; mindfulness with parental enhancement) or control. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
excel randomisation will be used, with a priori rules regarding allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/03/2015
Date of last participant enrolment
Anticipated
27/04/2015
Actual
3/07/2015
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
350
Accrual to date
Final
557
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 9247 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 290781 0
University
Name [1] 290781 0
Flinders University
Country [1] 290781 0
Australia
Funding source category [2] 290782 0
Charities/Societies/Foundations
Name [2] 290782 0
Fraser Mustard Centre
Country [2] 290782 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Psychology, Flinders University
GPO Box 2100
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 289466 0
Charities/Societies/Foundations
Name [1] 289466 0
Fraser Mustard Centre
Address [1] 289466 0
Level 8, 31 Flinders Street
Adelaide SA 5000
Country [1] 289466 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292413 0
Social and Behavioural Sciences Research Committee, Flinders University
Ethics committee address [1] 292413 0
Flinders University
GPO Box 2100
Adelaide SA 5001
Ethics committee country [1] 292413 0
Australia
Date submitted for ethics approval [1] 292413 0
Approval date [1] 292413 0
17/02/2015
Ethics approval number [1] 292413 0
6534 - modification to design

Summary
Brief summary
Mindfulness is an approach showing promise for youth, but at present the methodological quality of studies in this domain is low. This study is an extension of a pilot study and seeks to compare an 8 week mindfulness programme, the .b mindfulness in schools curriculum, with a control group and with a group receiving the mindfulness curriculum PLUS parental support (an information session and weekly updates regarding lesson content and practices taught). The inclusion of the latter is aimed at improving compliance with home practice, with evidence suggesting that this is positively related to improved outcomes.
Hypotheses
1. It is predicted that the primary outcome measures of anxiety, depression and weight/shape concerns will be lower in the parental enhanced mindfulness group compared to the standard mindfulness group, which will in turn be lower than in the control group at post-intervention and follow-up.
2. It is predicted that the primary outcome measure of wellbeing will be higher in the parental enhanced mindfulness group compared to the standard mindfulness group, which will in turn be higher than in the control group at post-intervention and follow-up.
3. It is predicted that the mindfulness interventions (both groups) will be more effective in improving the primary outcome variables (anxiety, depression, wellbeing, and weight/shape concerns) in those with high levels of anxiety, depression, and weight/shape concerns (i.e., in those who need it most). Additional moderators will also be examined (socioeconomic status, gender, lesson length - which varies across schools) however no prediction is made as to the direction of influence for these variables.
4. It is predicted that the parental enhanced mindfulness group will report higher levels of homework practice than the standard mindfulness intervention.
5. It is predicted that improved outcomes in the parental enhanced mindfulness group will be mediated at least partially by level of homework practice.
6. No prediction is made as to which facets of mindfulness (as measured on the CHIME-Youth scale) act as mediators for improvements in outcome measures.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55118 0
Ms Catherine Johnson
Address 55118 0
School of Psychology, Flinders University
GPO Box 2100
Adelaide SA 5001
Country 55118 0
Australia
Phone 55118 0
+61 8 82015122
Fax 55118 0
Email 55118 0
[email protected]
Contact person for public queries
Name 55119 0
Catherine Johnson
Address 55119 0
School of Psychology, Flinders University
GPO Box 2100
Adelaide SA 5001
Country 55119 0
Australia
Phone 55119 0
+61 8 82015122
Fax 55119 0
Email 55119 0
[email protected]
Contact person for scientific queries
Name 55120 0
Catherine Johnson
Address 55120 0
School of Psychology, Flinders University
GPO Box 2100
Adelaide SA 5001
Country 55120 0
Australia
Phone 55120 0
+61 8 82015122
Fax 55120 0
Email 55120 0
[email protected]

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