Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

Please be advised that as the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000435280
Ethics application status
Approved
Date submitted
19/03/2018
Date registered
26/03/2018
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Early Minds Mindfulness Study: The feasibility and acceptability of a preschool mindfulness program within an early childhood setting
Scientific title
The feasibility and acceptability of the Early Minds preschool mindfulness program within an early childhood setting: A pilot RCT
Secondary ID [1] 294377 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Emotional Wellbeing 307107 0
Condition category
Condition code
Mental Health 306218 306218 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a preschool mindfulness program called the Early Minds program. The program has been written and developed by Smiling Mind in partnership with Early Childhood Australia (ECA). It has been designed to be delivered by early childhood educators, within Early Learning Centres (ELCs), during standard operating hours. Educators in the intervention arm are trained by Smiling Mind via two online learning modules. Each module will take approximately one hour to complete. Intervention educators are provided with a program manual describing the program activities and describing any props useful for implementation.

The program is an 8-week intervention consisting of mindfulness-based meditations and simple mindfulness activities. The meditations and activities will be conducted at least three times per week and last for between two and 15 minutes, depending on the activity. The activities are whole group or small group activities. The meditations will be played from recordings from the Smiling Mind website/app. The activities will be face-to-face using props and/or other learning tools as required.

The program is designed to be flexible, with educator’s choosing the components they implement and how frequently beyond the recommended 3 sessions per week they are conducted. Parents of children in the intervention arm will have access to the meditations via the Smiling Mind website/app, to use at home. The app-based meditations are based on the following themes: body scan; gratitude; breath, curiosity; sounds. The program activities are based on the five learning outcomes for children birth to 5 years, presented in the Early Years Learning Framework for Australia (2009). The themes for the program activities are: children... are effective communicators; are confident and involved learners; have a strong sense of wellbeing; are connected with and contribute to their world; have a strong sense of identity; and movement. Activities with and without movement have been developed.

As part of the evaluation, fidelity will be assessed. Educators will be provided with a folder containing a daily checklist of all program meditations and activities. Educators will tick which meditations and/or activities they conducted, how frequently, and the proportion of the activity completed each day. Dose will be assessed using class attendance lists.
Intervention code [1] 300680 0
Treatment: Other
Comparator / control treatment
The comparison group will be standard curriculum/usual care group. Participants are recruited through Early Learning Centres. Participants assigned to the usual care group will follow their standard curriculum or standard care.
Control group
Active

Outcomes
Primary outcome [1] 305237 0
Feasibility of the program assessed by uptake of educators into the study, and study designed questions assessing educator report of program use and barriers to implementation
Timepoint [1] 305237 0
Baseline, 3 months post-randomisation (primary timepoint) and 12 months post-randomisation
Primary outcome [2] 305238 0
Acceptability of the program assessed by study-designed questions about educator confidence, competence, and program usefulness
Timepoint [2] 305238 0
Baseline, 3 months post-randomisation (primary timepoint), 12 months post-randomisation
Primary outcome [3] 305239 0
Program fidelity assessed by study designed questions assessing educator implementation of activities, including identification of meditations and activities used, frequency of use, and proportion of activity completion
Timepoint [3] 305239 0
Weekly during the course of the intervention
Secondary outcome [1] 344561 0
Feasibility of the evaluation study as assessed by intake of children and families into the study, and parent participant retention rates
Timepoint [1] 344561 0
Baseline, 3 months post-randomisation, 12 months post randomisation
Secondary outcome [2] 344562 0
Child social-emotional wellbeing measured by the Strengths and Difficulties Questionnaire (parent report)
Timepoint [2] 344562 0
Baseline, 3 months post-randomisation and 12 months post-randomisation
Secondary outcome [3] 344563 0
Child social-emotional wellbeing measured by the Strengths and Difficulties Questionnaire (educator report)
Timepoint [3] 344563 0
Baseline and 3 months post-randomisation
Secondary outcome [4] 344565 0
Child irritability measured by the Affective Reactivity Index (parent report)
Timepoint [4] 344565 0
Baseline, 3 months post-randomisation and 12 months post-randomisation
Secondary outcome [5] 344567 0
Child irritability measured the Affective Reactivity Index (educator report)
Timepoint [5] 344567 0
Baseline and 3 months post-randomisation
Secondary outcome [6] 344571 0
Child sleep problems measured by a single item from the Longitudinal Study of Australian Children (parent report)
Timepoint [6] 344571 0
Baseline, 3 months post-randomisation and 12 months post-randomisation
Secondary outcome [7] 344572 0
Child day-time sleepiness measured by single item from the Pediatric Sleep Questionnaire (parent report)
Timepoint [7] 344572 0
Baseline, 3 months post-randomisation and 12 months post-randomisation
Secondary outcome [8] 344573 0
Child day-time sleepiness measured by single item from the Pediatric Sleep Questionnaire (educator report)
Timepoint [8] 344573 0
Baseline and 3 months post-randomisation
Secondary outcome [9] 344574 0
Child executive functioning measured by the Childhood Executive Functioning Inventory (parent report)
Timepoint [9] 344574 0
Baseline, 3 months post-randomisation and 12 months post-randomisation
Secondary outcome [10] 344575 0
Child executive functioning measured by the Childhood Executive Functioning Inventory (educator report)
Timepoint [10] 344575 0
Baseline and 3 months post-randomisation
Secondary outcome [11] 344576 0
Child approaches to learning measured by the Kindergarten through first grade parent social rating scale (SRS) (Approaches to Learning scale items) (parent report)
Timepoint [11] 344576 0
Baseline, 3 months post-randomisation and 12 months post-randomisation
Secondary outcome [12] 344577 0
Child approaches to learning measured by the Kindergarten through first grade parent Social Rating Scale (SRS) (Approaches to Learning scale items) (educator report)
Timepoint [12] 344577 0
Baseline and 3 months post-randomisation
Secondary outcome [13] 344578 0
Educator self-report mindfulness measured by the Cognitive and Affective Mindfulness Scale-revised
Timepoint [13] 344578 0
Baseline, 3 months post-randomisation and 12 months post-randomisation
Secondary outcome [14] 344579 0
Educator-class relationship measured using an adapted version of the Student–Teacher Relationship Scale (STRS) (educator report)
Timepoint [14] 344579 0
Baseline and 3 months post-randomisation

Eligibility
Key inclusion criteria
Early Childhood Educators – working within the 3-year old- and/or 4-year old rooms at Early Learning Centres (ELCs) recruited by Smiling Mind to participate in the trial

Children and caregivers of children - enrolled and attending the ELC rooms lead by educators talking part in the study at the time of the baseline measures
Minimum age
3 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
English language skills that precludes the ability to provide informed consent

Inability to complete the study surveys, written at a grade 6 reading level (the option of completion with a member of the researcher team will be offered)

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 will be concealed. An independent statistician or experienced researcher will pre-generate a random number sequence which contains the randomisation sequence number and the group allocated (program v control). Allocation will be concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
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. The data analyst will be blinded
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The primary aim of this pilot study is to evaluate the feasibility and acceptability of conducting the Early Minds program within early learning centres, as such formal power calculations were not conducted. Secondary aims will investigate preliminary impacts of the program, but will not determine efficacy. Sample characteristics will be described. Educator report of the program’s acceptability, frequency of use, ease of use, and barriers to use, will be reported. Although not a trial designed to determine efficacy of the intervention, mean differences (baseline to 3-months) for educator- and caregiver-reported child outcomes will be reported and will provide important data to calculate sample size and power for any larger efficacy trial conducted.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299015 0
Charities/Societies/Foundations
Name [1] 299015 0
Ian Potter Foundation
Address [1] 299015 0
Level 3, 111 Collins Street
Melbourne VIC 3000

Country [1] 299015 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 298241 0
None
Name [1] 298241 0
Address [1] 298241 0
Country [1] 298241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299953 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 299953 0
The Royal Children's Hospital
50 Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 299953 0
Australia
Date submitted for ethics approval [1] 299953 0
23/10/2017
Approval date [1] 299953 0
08/02/2018
Ethics approval number [1] 299953 0
HREC#37267

Summary
Brief summary
Smiling Mind is a not for profit organisation that develops app-based mindfulness programs to support the wellbeing of children, young people and adults. Smiling Mind has previously developed mindfulness-based programs for primary and secondary school age children. In partnership with Early Childhood Australia (ECA) they have developed a mindfulness program for pre-school age children, called the Early Minds program. The program has been designed to be implemented by trained early childhood educators within Early Learning Centres (ELCs). Educators will be trained by two online learning modules prior to implementing the program, which consists of 8-weeks of mindfulness–based meditations and activities. The aim of this pilot study, led by the Murdoch Children’s Research Institute, is to evaluate the feasibility and acceptability of conducting the Early Minds program within selected Victorian ELCs. Educator’s experience of the program, use of the program, and barriers to use will be examined. Secondary aims will explore preliminary impacts of the program on educator and caregiver reported child wellbeing and behaviour. Educators will be randomised into the program group or the usual care group. Children will be placed in the group their educator is in. Participants will complete surveys at three months post-randomisation to assess primary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82066 0
Prof Harriet Hiscock
Address 82066 0
Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052
Country 82066 0
Australia
Phone 82066 0
+61 3 9345 6910
Fax 82066 0
Email 82066 0
harriet.hiscock@rch.org.au
Contact person for public queries
Name 82067 0
Dr Jane Sheehan
Address 82067 0
Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052
Country 82067 0
Australia
Phone 82067 0
+61 3 8341 6384
Fax 82067 0
Email 82067 0
jane.sheehan@mcri.edu.au
Contact person for scientific queries
Name 82068 0
Dr Jane Sheehan
Address 82068 0
Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052
Country 82068 0
Australia
Phone 82068 0
+61 3 8341 6384
Fax 82068 0
Email 82068 0
jane.sheehan@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
The data set will not be made publicly available. Requests will be considered on a case-by-case basis.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 213 0
Study protocol
Citation [1] 213 0
Link [1] 213 0
Email [1] 213 0
Other [1] 213 0
The study team aim to publish the study protocol and will upload the details of the article as soon as it is available.
Attachment [1] 213 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary