Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001313224
Ethics application status
Approved
Date submitted
30/07/2018
Date registered
6/08/2018
Date last updated
6/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindful M.A.T. Time for Preschoolers - Pilot Study: Mindful Movement, Attention/Awareness, and Thoughts Time
Scientific title
Mindful M.A.T. Time for Preschoolers - Pilot RCT Study: Mindful Movement, Attention/Awareness, and Thoughts Time
Secondary ID [1] 295692 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Emotional Wellbeing 309066 0
Self-regulation 309067 0
Executive Functioning 309136 0
Condition category
Condition code
Mental Health 307951 307951 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mindful M.A.T. Time for Early Years program was designed to use developmentally appropriate practices, play-based activities, and games/stories, utilising hands-on props and active learning, to promote mindful movement, attention/awareness, and thinking skills.

It was designed specifically for preschool children and incorporate activities that focus on: (i) breathing, (ii) working with thoughts and emotions, (iii) psychoeducation, (iv) awareness of senses, (v) bodyscan and muscle relaxation, (vi) kindness, empathy, and gratitude practices, and (viii) mindful movement. The program also includes weekly tasks which can be completed at home by parents and family.

The program consists of classroom teachers implementing two fun and engaging mindfulness-based activities (which take around 5-10 minutes each), face-to-face, 3 times a week (36 sessions in total) for the whole class, plus recommended storybooks each week. During the initial 12-week program, there is a sequenced checklist of games and activities, with many repeated throughout, as ongoing practice has been found to be critical for the effectiveness of mindfulness.

Activity topics and examples include; (i) breathing – focus on belly breathing with “rock buddy”, (ii) working with thoughts and emotions – imagining “thoughts as bubbles” (iii) psycho-education – “brain as a house”, (iv) awareness of senses – “no look” object-touching game (v) body-scan and muscle relaxation – “robot shutting down”, (vi) kindness, empathy, and gratitude – “secret sender” letters, and (viii) mindful movement – “batteries on low”.

Intervention teachers will be provided with an easy-to-follow program manual explaining the fun and simple mindfulness-based classroom activities (including extensions and modifications), curriculum/framework aligned activity lesson plans, and a 40-minute educational training video. They will attend a 1-day PD workshop, delivered by the program author and psychologist, covering mindfulness theory, research, and program implementation. Props and storybooks are a core feature of the program and are provided to intervention groups. No direct measures of intervention monitoring, adherence, or fidelity have been included.
Intervention code [1] 302009 0
Behaviour
Intervention code [2] 302010 0
Treatment: Other
Comparator / control treatment
The comparison/control group will not receive the mindfulness intervention but may receive other wellbeing support from their early childhood centres. Classrooms allocated to this group will be referred to as 'usual teaching/care group' and will follow their standard teaching or care curriculum/approaches.
Control group
Active

Outcomes
Primary outcome [1] 306925 0
Child visuo-spatial attention-working memory as measured by a modified Corsi Block Span task
Timepoint [1] 306925 0
Baseline, Immediate post-intervention, 2-month follow-up
Primary outcome [2] 306926 0
Child verbal/auditory attention-working memory as measured by Digit Span task from Children's Memory Scale (CMS)
Timepoint [2] 306926 0
Baseline, Immediate post-intervention, 2-month follow-up
Primary outcome [3] 306927 0
Child Behaviour and Social-emotional Wellbeing as measured by the Strengths and Difficulties Questionnaire (teacher report)
Timepoint [3] 306927 0
Baseline, Immediate post-intervention, 2-month follow-up
Secondary outcome [1] 350131 0
Child Affective Inhibition as measured by the Less is More task
Timepoint [1] 350131 0
Baseline, Immediate post-intervention, 2-month follow-up
Secondary outcome [2] 350132 0
Child Non-affective Inhibition as measured by the Heads-Toes-Knees-Shoulders task
Timepoint [2] 350132 0
Baseline, Immediate post-intervention, 2-month follow-up
Secondary outcome [3] 350133 0
Child Cognitive Flexibility as measured by the Minnesota Executive Function Scales (MEFS; also known as the Dimensional Color Card Sort)
Timepoint [3] 350133 0
Baseline, Immediate post-intervention, 2-month follow-up
Secondary outcome [4] 350134 0
Child Information Processing Speed as measured by the WPSSI-IV (Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition) Bug Search subtest
Timepoint [4] 350134 0
Baseline, Immediate post-intervention, 2-month follow-up
Secondary outcome [5] 350135 0
Child Prosocial Behaviour as measured by a modified Dictator Sticker Sharing task
Timepoint [5] 350135 0
Baseline, Immediate post-intervention, 2-month follow-up
Secondary outcome [6] 350136 0
Child Behaviour and Social-emotional Wellbeing as measured by the BASC-3 (Behavior Assessment System for Children, Third Edition) Parent report
Timepoint [6] 350136 0
Baseline, Immediate post-intervention, 2-month follow-up

Eligibility
Key inclusion criteria
The key inclusion criteria was Early Childhood Centres co-located with a Primary school, with at least one 4-year-old preschool classroom, and located in a lower socio-economically disadvantaged metropolitan Melbourne region (defined by bottom 20th percentile on SEIFA [Socio-Economic Indexes for Areas] or neighbouring suburb). No specific inclusion criteria were specified for teachers, children or parents, other than informed adult and guardian consent or assent (for children).
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria were:
Parents:
(i) English language skills that preclude the ability to provide informed consent;
(ii) inability to complete the study surveys
Children:
(i) English language skills that preclude the ability to provide informed assent to assessment; (ii) inability to follow and complete the assessment protocol; and/or
(iii) Children with a known severe developmental disability (e.g., Intellectual disability or Autism Spectrum Disorder)
No specific exclusion criteria were specified for teachers

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation of Early Childhood Centres will be conducted by the lead researcher. This will involve simple randomisation using a computerised sequence generator. Randomisation will occur at the Preschool Centre level, not classroom or individual participant level.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Educators, families and research assistants will be blind to group allocation at the time of recruitment, but not thereafter.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary aim of this study was to pilot the intervention, outcomes measures, and general acceptability, as such formal power calculations were not conducted. Statistical analysis will follow standard methods for randomised controlled trials. The primary analysis will be by intention-to-treat and will include all randomised participants where outcome data are available. Primary and secondary outcomes analysis will use linear mixed effects modelling, which incorporates baseline data into the model. Findings between groups at baseline, immediate post-intervention, and at 2-month follow-up will be presented as group means with 95% Confidence Intervals, p-values, and Cohen's d and Hedge's g effect sizes, including within group and between group effect sizes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2017
Date of last participant enrolment
Anticipated
Actual
22/05/2017
Date of last data collection
Anticipated
Actual
15/12/2017
Sample size
Target
120
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300273 0
University
Name [1] 300273 0
The University of Melbourne
Country [1] 300273 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country
Australia
Secondary sponsor category [1] 299705 0
Other
Name [1] 299705 0
Murdoch Children's Research Institute
Address [1] 299705 0
Clinical Sciences
Murdoch Children's Research Institute
Flemington Road
Parkville, Victoria 3052
Country [1] 299705 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301089 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 301089 0
Ethics committee country [1] 301089 0
Australia
Date submitted for ethics approval [1] 301089 0
24/10/2016
Approval date [1] 301089 0
12/01/2017
Ethics approval number [1] 301089 0
1545973

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

Contacts
Principal investigator
Name 85846 0
Dr Ben Deery
Address 85846 0
Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country 85846 0
Australia
Phone 85846 0
+61 3 8344 0058
Fax 85846 0
Email 85846 0
b.deery@unimelb.edu.au
Contact person for public queries
Name 85847 0
Ben Deery
Address 85847 0
Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country 85847 0
Australia
Phone 85847 0
+61 3 8344 0058
Fax 85847 0
Email 85847 0
b.deery@unimelb.edu.au
Contact person for scientific queries
Name 85848 0
Ben Deery
Address 85848 0
Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country 85848 0
Australia
Phone 85848 0
+61 3 8344 0058
Fax 85848 0
Email 85848 0
b.deery@unimelb.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.