Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000326190
Ethics application status
Approved
Date submitted
1/02/2019
Date registered
4/03/2019
Date last updated
12/04/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Minds@Play: Understanding whether mindfulness in the classroom can improve student outcomes
Scientific title
Understanding the efficacy of a teacher-led mindfulness intervention on improving student attention, behaviour and executive functioning: A cluster randomised controlled trial
Secondary ID [1] 297273 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Mindfulness 311345 0
Condition category
Condition code
Public Health 309982 309982 0 0
Health promotion/education
Mental Health 310223 310223 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Teacher-led mindfulness activities within the classrooms of students in the first and second year of primary school

Teacher training: For schools assigned to the intervention group, Foundation (2019) and Grade 1 (2020) teachers will attend a 1-day professional development (PD) day.

The PD day will provide teachers with the theoretical and practical foundation about the program, and training for running the program in their class. The training will be provided by Dr Deery, who developed the program and is a registered clinical psychologist and teacher.
Using principals of effective teacher professional development, the training will focus on increasing content theoretical and practical knowledge, active learning and examples of effective practice and provides coaching and expert support. Teachers will be provided with a manualised version of the intervention, which includes a program schedule for the 12-week intervention, lesson plans and communication templates, examples of activities, parent homework sheets, video and music clips, and a copy of the training slides. As part of the training, they will review the material, experience some of the activities and can ask questions. A pre and post survey will be administered to understand teacher knowledge and confidence changed through the PD.

During the next 12-weeks, the teachers will implement the intervention, using the manual to help them to learn, practice, implement, and reflect on the new strategies that help change practice implement. Adherence to the initial 12 weeks will be monitored via fortnightly ‘check in’ emails to measure what teachers have been implementing, as well as any barriers experienced during the past fortnight. The three types of mindfulness activities within the classroom will be:

1. Conduct mindfulness activities during the day, targeting key school transitions (e.g., coming from outside to inside, after lunch/recess, before a test/specialist class, or on arrival or before school departure). This is to occur at least twice a day for three days a week.
2. Read relevant readily available storybooks (i.e. Inside Out, Charlie and the Chocolate Factory) and discuss with children connections to mindfulness and other skills/concepts. This is to occur at least three times per week.
3. Establish a ‘Mindful Space’ in the classroom and include mindful props (e.g., mind jar), games (e.g., Uno, rock balancing), activities (e.g., mindful drawing, maze drawing), and storybooks/audiobooks from the week.

Teachers will also be asked to look for and embed spontaneous ‘mindful moments’ into their day, such as using ‘slow motion’ walking to the library or watching ‘rain drops racing’ on a rainy day. Along with the manualised program and initial PD training, three additional forms of support will be provided to the teachers.

1. Props, books and other resources (e.g. door posters) will be provided, which also include key elements of the program and prompts for mindful moments.
2. Teachers will hold 30-minute fortnightly meetings at their school to reflect on the intervention’s progress, implementation, and any support needs, providing peer support and shared commitment to the program. Notes from these meetings will be collected and used as part of the process evaluation. In Year 2, Foundation teachers will continue to participate in these meetings, providing their own reflections and expertise to the Grade 1 teachers. This will examine the intervention’s sustainability in a ‘train the trainer model’.
3. Teachers will be provided with access to a secure, online social networking site that will be monitored by the research team. They will be encouraged to post examples of mindful activities, artwork and discussions. Parents will be invited to the community to be able to understand how they may implement mindfulness activities within the home which complements what is implemented at school, enabling connections between school, home, and ongoing support/resources. They will be encouraged to access the at least once per week.

After the end of the 12 weeks, we will conduct a 2-hour meeting with teachers at each school to reflect on the learnings from the initial 12-week manualised implementation and to develop an ongoing implementation plan.
Intervention code [1] 313525 0
Prevention
Intervention code [2] 313678 0
Behaviour
Comparator / control treatment
School business as usual. Schools will be able to implement any intervention they wish for the students, but will not be provided with the mindfulness PD or an implementation/support materials during this study.
Control group
Active

Outcomes
Primary outcome [1] 318898 0
Child Attention, as measured by the Corsi Block Tapping Test
Timepoint [1] 318898 0
15 months post-randomisation
Secondary outcome [1] 366366 0
Academic Outcomes, as measured by the WRAT-4
Timepoint [1] 366366 0
24months post randomisation
Secondary outcome [2] 366991 0
Child behaviour, as measured by the parent and teacher reported Strengths and Difficulties Questionnaire
Timepoint [2] 366991 0
3-, 15- and 24-mth post-randomisation
Secondary outcome [3] 367599 0
Verbal attention as measured by the Forward and Backward Digit Span
Timepoint [3] 367599 0
15- and 24-mth post-randomisation
Secondary outcome [4] 367600 0
Attention, self-regulation and inhibitory control as measured by the Flanker Inhibitory Control and Attention Test
Timepoint [4] 367600 0
15- and 24-mth post-randomisation
Secondary outcome [5] 367601 0
Executive functioning, as measured by the parent and teacher-reported Childhood Executive Functioning Inventory
Timepoint [5] 367601 0
3-, 15- and 24-mth post-randomisation
Secondary outcome [6] 367602 0
Child learning, as measured by the teacher-reported Approaches To Learning
Timepoint [6] 367602 0
3-, 15- and 24-mth post-randomisation
Secondary outcome [7] 367603 0
Parenting as measured by the parent-reported Interpersonal Mindfulness in Parenting
Timepoint [7] 367603 0
3-, 15- and 24-mth post-randomisation
Secondary outcome [8] 367604 0
Teacher and parent well-being, as measured by the Short Warwick Edinburgh Mental Well-Being Scale
Timepoint [8] 367604 0
3-, 15- and 24-mth post-randomisation
Secondary outcome [9] 367605 0
Parent and teacher mental health, as measured by the self-reported Kessler 6
Timepoint [9] 367605 0
3-, 15- and 24-mth post-randomisation
Secondary outcome [10] 367606 0
Child self-regulation, as measured by the parent-reported Affective Reactivity Scale
Timepoint [10] 367606 0
3-, 15- and 24-mth post-randomisation
Secondary outcome [11] 367607 0
Teacher mindfulness, as measured by the teacher-reported Mindfulness In Teaching Scale
Timepoint [11] 367607 0
3-, 15- and 24-mth post-randomisation
Secondary outcome [12] 367609 0
Teacher classroom practice, as measured by the observation tool CLASS
Timepoint [12] 367609 0
At 15-mth post randomisation

Eligibility
Key inclusion criteria
All students in the first year of primary school at participating schools at the time of study recruitment
Minimum age
5 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Proficient English to complete assessments

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of schools to the 'Mindfulness intervention" versus Business as Usual groups will be concealed from members of the research team involved in outcome assessments for the duration of the project. The allocation will be conducted by an independent statistician who is independent of the research team to ensure concealment from the research team. Once all children have been recruited by the research team, the statistician will randomise schools with only the school's study ID.

Because school staff, teachers and students will not be blinded, they will be asked not to disclose student randomisation status to the research staff when the research staff conduct assessments at their schools. However, in cases of disclosure, this information will be recorded in the project database and ‘unblinding’ will be examined as a potential confounding variable in the outcome analyses.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be conducted by a statistician who is independent of the research team. This will involve simple randomisation using a sequence generated by statistical software, STATA.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise baseline participant and school characteristics by group.

All primary and secondary outcomes will be by intention-to-treat. The primary outcome is student attention at the End of Year 1. To account for clustering of child school and class, the primary analysis will adopt a two level random effects linear regression model to examine the Corsi score (continuous) for the intervention students, compared to control students. Both unadjusted and adjusted analyses will be conducted. Adjusted analyses will include baseline Corsi score and a priori confounders of student age at baseline, gender and family SES.

For secondary outcomes analyses, continuous variables will use the same unadjusted and adjusted mixed-effect linear regression models described for the primary outcome and categorical data will use mixed-effect logistic regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2019
Actual
Date of last participant enrolment
Anticipated
21/06/2019
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
826
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301824 0
Government body
Name [1] 301824 0
Australian Research Council
Country [1] 301824 0
Australia
Primary sponsor type
University
Name
Melbourne Graduate School of Education, The University of Melbourne
Address
Melbourne Graduate School of Education
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country
Australia
Secondary sponsor category [1] 301577 0
None
Name [1] 301577 0
Address [1] 301577 0
Country [1] 301577 0
Other collaborator category [1] 280513 0
University
Name [1] 280513 0
Deakin University
Address [1] 280513 0
Melbourne Burwood Campus,
221 Burwood Hwy, Burwood VIC 3125
Country [1] 280513 0
Australia
Other collaborator category [2] 280514 0
Other
Name [2] 280514 0
Murdoch Childrens Research Institute
Address [2] 280514 0
Flemington Road
Parkville, Victoria 3052
Country [2] 280514 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302527 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 302527 0
Ethics committee country [1] 302527 0
Australia
Date submitted for ethics approval [1] 302527 0
01/02/2019
Approval date [1] 302527 0
08/04/2019
Ethics approval number [1] 302527 0
1853492

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90526 0
Dr Jon Quach
Address 90526 0
Melbourne Graduate School of Education
Level 4, 100 Leicester Street
Carlton VIC 3010
Country 90526 0
Australia
Phone 90526 0
+61 3 8344 1200
Fax 90526 0
Email 90526 0
jon.quach@unimelb.edu.au
Contact person for public queries
Name 90527 0
Jon Quach
Address 90527 0
Melbourne Graduate School of Education
Level 4, 100 Leicester Street
Carlton VIC 3010
Country 90527 0
Australia
Phone 90527 0
+61 3 8344 1200
Fax 90527 0
Email 90527 0
jon.quach@unimelb.edu.au
Contact person for scientific queries
Name 90528 0
Jon Quach
Address 90528 0
Melbourne Graduate School of Education
Level 4, 100 Leicester Street
Carlton VIC 3010
Country 90528 0
Australia
Phone 90528 0
+61 3 8344 1200
Fax 90528 0
Email 90528 0
jon.quach@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
1st January 2022 to 20th December 2027
Available to whom?
Researchers who have ethics approval through the University of Melbourne to conduct secondary data analysis
Available for what types of analyses?
As approved by University of Melbourne ethics
How or where can data be obtained?
Direct contact with the study team


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.