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Trial registered on ANZCTR
Registration number
ACTRN12622000877785
Ethics application status
Approved
Date submitted
15/06/2022
Date registered
21/06/2022
Date last updated
11/08/2023
Date data sharing statement initially provided
21/06/2022
Date results information initially provided
11/08/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
A school-based cognitive intervention for developmentally vulnerable primary school children following the COVID-19 pandemic: The Pillar Project
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Scientific title
A school-based digital intervention to mitigate the negative impact of the COVID-19 pandemic on executive functioning in developmentally vulnerable primary school children: a pilot randomised controlled trial
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Secondary ID [1]
307362
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None
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Universal Trial Number (UTN)
U1111-1257-0670
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Developmental Vulnerability
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Executive dysfunction
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Condition category
Condition code
Mental Health
323908
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The classroom-based, gamified executive function training program is administered via a touchscreen tablet. The program targets core executive functions including inhibitory control, working memory and cognitive flexibility. The program will be administered by classroom educators. Participating Grade 1 and 2 students will complete a total of twenty sessions, each 30 minutes in duration over a 6 - 7 week period. The six adaptive training tasks (two per executive function) are embedded within an overarching game, where children are required to help their selected character, a butterfly or moth, restore their world and help feed and nurture its inhabitants (e.g. caterpillars) after a devastating storm. At the completion of the training exercises, children acquire rewards that can be used to restore the world and can access new features used to customise their butterfly or moth character (i.e. patterns and accessories). Adherence to the intervention will be monitored remotely by a member of the research team using app analytics.
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Intervention code [1]
323788
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Treatment: Other
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Intervention code [2]
323817
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Treatment: Devices
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Comparator / control treatment
Participating students who are assigned to the active control group (treatment-as-usual) will attend their usual class activities at school.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome is a difference between the intervention group and the control group in response inhibition as measured by the Open Source Anticipated Response Inhibition (OSARI) task.
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Assessment method [1]
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Timepoint [1]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Secondary outcome [1]
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A difference between the intervention group and the control group in Executive Dysfunction as measured by the parent-rated Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
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Assessment method [1]
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Timepoint [1]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Secondary outcome [2]
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A difference between the intervention group and the control group in Social and Emotional Wellbeing as measured by the parent-rated Strengths and Difficulties Questionnaire.
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Assessment method [2]
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Timepoint [2]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Secondary outcome [3]
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A difference between the intervention group and the control group in Social and Emotional Wellbeing as measured by the teacher-rated Strengths and Difficulties Questionnaire.
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Assessment method [3]
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Timepoint [3]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Secondary outcome [4]
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A difference between the intervention group and the control group in conflict resolution as measured by the Attention Network Task - Child Version.
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Assessment method [4]
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Timepoint [4]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Secondary outcome [5]
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A difference between the intervention group and the control group in verbal working memory as measured by the Backwards Digit Span Task.
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Assessment method [5]
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Timepoint [5]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Secondary outcome [6]
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A difference between the intervention group and the control group in visuo-spatial working memory as measured by the Corsi Block Tapping Task.
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Assessment method [6]
410853
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Timepoint [6]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Secondary outcome [7]
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A difference between the intervention group and the control group in cognitive flexibility (set shifting) as measured by the Wisconsin Card Sorting Test (WCST).
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Assessment method [7]
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Timepoint [7]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Secondary outcome [8]
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A difference between the intervention group and the control group in cognitive flexibility (matching) as measured by the Dimension Change Card Sorting Task (DCCS).
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Assessment method [8]
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Timepoint [8]
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1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
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Eligibility
Key inclusion criteria
Schools will be eligible to participate if they are located in areas with (a) high levels of childhood developmental vulnerability as defined by the Australian Early Development Census (above the 80th percentile) and/or (b) low levels of socioeconomic status (SES) based on the national Socio-Economic Indexes for Areas (SEIFA score below 950).
Children will be eligible to participate if they are in Grade 1 or 2 within these eligible schools.
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Minimum age
5
Years
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Maximum age
8
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Children will be excluded from the trial if they have either (a) a clinically diagnosed intellectual disability (IQ<70), and (b) significant motor, communication or sensory impairments reported by parents that would impact their ability to participate.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher not directly involved in the analysis of the study results will be responsible for the implementation of the allocation. Allocation will be concealed using central randomisation by a computer. The documentation pertaining to the randomisation will be securely stored and inaccessible to researchers undertaking recruitment and testing.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (ratio 1:1, with blocks of 10) will be used to maintain balance between intervention arms. Computer-generated random numbers will be used to allocate participants.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Researchers conducting screening and assessments will be unaware of group allocation for the duration of the trial (including data analysis). Prior to the commencement of each assessment session participants will be explicitly instructed not to discuss the contents of their assigned program with the researcher. Group allocation details and randomisation codes will only be available once all data collected has been entered into the study database for every participant and the database has been finalised, except in the case of an emergency. For any researcher for whom the study blind is broken, the date, time, participant ID and reason for unblinding must be documented.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary endpoint, to demonstrate efficacy, is the Post-intervention assessment (7 weeks after commencement of intervention). The follow-up assessment (13 weeks after commencement of intervention) is defined as secondary endpoint (may demonstrate additional effects after the primary endpoint).
For the primary and secondary objectives, linear regression models will be constructed with the difference in the endpoint of interest between pre-intervention and post-intervention (either 7 weeks or 13 weeks) as the dependent variable, and treatment group assignment as the independent variable. The baseline value of the endpoint of interest, and age at the start of treatment will be controlled for by including them as confounders in the model. Mean values of all primary and secondary objectives will be tabulated by treatment group and assessment time point. For all models, the point estimate of the effect of interest and its 95% CI will be provided. The p-value for the hypothesis test with the null hypothesis of no effect will also be provided.
Exploratory analyses will be conducted to assess the potential effect of the following factors on training outcomes: sociodemographic factors, intrinsic motivation, family functioning and expectancy.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
11/07/2022
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Actual
9/06/2022
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Date of last participant enrolment
Anticipated
29/07/2022
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Actual
20/07/2022
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Date of last data collection
Anticipated
28/10/2022
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Actual
15/12/2022
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Sample size
Target
100
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Accrual to date
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Final
116
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The Ian Potter Foundation
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Address [1]
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Level 3, 111 Collins St
Melbourne VIC 3000
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr Hannah Kirk
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Address
Room 504, 18 Innovation Walk,
Monash University,
Clayton VIC 3800
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
313088
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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Office of Research Ethics and Integrity,
26 Sports Walk, Monash University,
Wellington Road, Clayton VIC 3800
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
311099
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08/11/2019
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Approval date [1]
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19/12/2019
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Ethics approval number [1]
311099
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22515
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Ethics committee name [2]
311102
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Department of Education and Training
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Ethics committee address [2]
311102
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2 Treasury Place
East Melbourne Vic 3002
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Ethics committee country [2]
311102
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Australia
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Date submitted for ethics approval [2]
311102
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20/12/2019
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Approval date [2]
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04/02/2020
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Ethics approval number [2]
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2019_004263
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Summary
Brief summary
Children living in remote/regional or low socio-economic communities have increased risk of developmental vulnerability. Executive function (EF) deficits, including those affecting inhibitory control, working memory and cognitive flexibility are common. Recent evidence indicates that individuals with pre-existing EF deficits were more vulnerable to the negative impacts of the COVID-19 pandemic and that these EF deficits have been exacerbated as a result of the pandemic. Strategies are therefore needed to provide support to mitigate the negative long-term impacts of the COVID-19 pandemic on cognitive (and executive) function in developmentally vulnerable children. This trial investigates whether a school-based digital intervention can improve key executive functions in primary school children at risk of developmental vulnerability. This parallel-group, randomised trial will recruit primary school students (aged 6-8 years) living in developmentally vulnerable communities across remote, regional and metropolitan areas of Victoria. Students will be randomised to receive 20 sessions of digital executive function training at school or to continue teaching as usual, for 7 weeks. Participants will be assessed pre-training, immediately post-training, and at a 6-week post-training follow-up. The primary outcome is post-training change in executive functioning as measured by cognitive assessments of working memory, inhibitory control and cognitive flexibility. Secondary outcomes include estimates of long-term change, and change in behavioural assessments of executive functioning and social/emotional wellbeing.
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Trial website
https://www.monash.edu/turner-institute/research/pillar-project
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Hannah Kirk
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Address
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18 Innovation Walk
Monash University
Wellington Rd
Clayton VIC 3800
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Country
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Australia
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Phone
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+61 3 9905 0230
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Hannah Kirk
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Address
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18 Innovation Walk
Monash University
Wellington Rd
Clayton VIC 3800
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Country
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Australia
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Phone
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+61 3 9905 0230
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Hannah Kirk
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Address
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18 Innovation Walk
Monash University
Wellington Rd
Clayton VIC 3800
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Country
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Australia
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Phone
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+61 3 9905 0230
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD including child assessment scores from 3 study time points (Pre intervention - week 1, post intervention - week 2, follow up - week 21)
1. Attention Network Test
2. Open Source Anticipated Response Task
3. Corsi Block Tapping Task
4. Backwards Digit Span
5. Modified Wisconsin Card Sort Task
6. Dimension Change Card Sort Test
7. Kaufman Brief Intelligence Test 2
Parent/Guardian Data
1. Strengths and Difficulties Questionnaire
2. Behaviour Rating Inventory of Executive Functioning 2
3. Dimension of Mastery Questionnaire
Educator Data
1. Strengths and Difficulties Questionnaire
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When will data be available (start and end dates)?
After August 2023
No end date
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Available to whom?
Open access to all on the Open Science Framework
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Available for what types of analyses?
Data will be provided in an excel format with raw scores from the measures described above for analyses deemed appropriate by researchers.
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How or where can data be obtained?
Open Science Framework - https://osf.io/wt3s2
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
16384
Study protocol
The Study Protocol has been made available via the Open Science Framework (OSF) web application. Kirk, H. (2022, June 15). School-based executive function training for developmentally vulnerable primary school children. Retrieved from osf.io/xmjr6
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Statistical analysis plan
The Study Protocol has been made available via the Open Science Framework (OSF) web application. Kirk, H. (2022, June 15). School-based executive function training for developmentally vulnerable primary school children. Retrieved from osf.io/xmjr6
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Informed consent form
384221-(Uploaded-15-06-2022-16-34-36)-Study-related document.pdf
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Ethical approval
384221-(Uploaded-15-06-2022-16-30-40)-Study-related document.pdf
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Analytic code
The Study Protocol has been made available via the Open Science Framework (OSF) web application. Kirk, H. (2022, June 15). School-based executive function training for developmentally vulnerable primary school children. Retrieved from osf.io/xmjr6
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Clinical study report
The Clinical study report will be made available via the Open Science Framework (OSF) web application. Kirk, H. (2022, June 15). School-based executive function training for developmentally vulnerable primary school children. Retrieved from osf.io/xmjr6
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.
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