ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1157-3112

Trial acronym

Linked study record

Health condition

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

Depression

Anxiety

Eating disorders

Wellbeing

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 (.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]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

Lessons as usual

Control group

Active

Outcomes

Primary outcome [1]

Depression and anxiety subscale scores, and total negative affect score on DASS-21

Timepoint [1]

two weeks prior to intervention, one week post intervention, 5 month and twelve month follow up

Primary outcome [2]

Weight and shape concerns subscales of the Eating Disorders Examination Questionnaire

Timepoint [2]

two weeks prior to intervention, one week post intervention, 5 month and twelve month follow up

Primary outcome [3]

Wellbeing (Warwick Edinburgh Mental Wellbeing Scale)

Timepoint [3]

two weeks prior to intervention, one week post intervention, 5 month and twelve month follow up

Secondary outcome [1]

Mindfulness (CHIME-youth multifactor questionnaire)

Timepoint [1]

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)

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

School of Psychology, Flinders University
GPO Box 2100
Adelaide SA 5000

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Fraser Mustard Centre

Address [2]

Level 8, 31 Flinders Street
Adelaide, South Australia, 5000

Country [2]

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]

Charities/Societies/Foundations

Name [1]

Fraser Mustard Centre

Address [1]

Level 8, 31 Flinders Street
Adelaide SA 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Social and Behavioural Sciences Research Committee, Flinders University

Ethics committee address [1]

Flinders University
GPO Box 2100
Adelaide SA 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/02/2015

Ethics approval number [1]

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

Ms Catherine Johnson

Address

School of Psychology, Flinders University
GPO Box 2100
Adelaide SA 5001

Country

Australia

Phone

+61 8 82015122

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

+61 8 82015122

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

+61 8 82015122

Fax

catherine.johnson@flinders.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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