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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
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
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
Secondary ID [1] 307362 0
None
Universal Trial Number (UTN)
U1111-1257-0670
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental Vulnerability 326667 0
Executive dysfunction 326668 0
Condition category
Condition code
Mental Health 323908 323908 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323788 0
Treatment: Other
Intervention code [2] 323817 0
Treatment: Devices
Comparator / control treatment
Participating students who are assigned to the active control group (treatment-as-usual) will attend their usual class activities at school.
Control group
Active

Outcomes
Primary outcome [1] 331715 0
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.
Timepoint [1] 331715 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
Secondary outcome [1] 410848 0
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)
Timepoint [1] 410848 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
Secondary outcome [2] 410849 0
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.
Timepoint [2] 410849 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
Secondary outcome [3] 410850 0
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.
Timepoint [3] 410850 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
Secondary outcome [4] 410851 0
A difference between the intervention group and the control group in conflict resolution as measured by the Attention Network Task - Child Version.
Timepoint [4] 410851 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
Secondary outcome [5] 410852 0
A difference between the intervention group and the control group in verbal working memory as measured by the Backwards Digit Span Task.
Timepoint [5] 410852 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
Secondary outcome [6] 410853 0
A difference between the intervention group and the control group in visuo-spatial working memory as measured by the Corsi Block Tapping Task.
Timepoint [6] 410853 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
Secondary outcome [7] 410854 0
A difference between the intervention group and the control group in cognitive flexibility (set shifting) as measured by the Wisconsin Card Sorting Test (WCST).
Timepoint [7] 410854 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)
Secondary outcome [8] 410855 0
A difference between the intervention group and the control group in cognitive flexibility (matching) as measured by the Dimension Change Card Sorting Task (DCCS).
Timepoint [8] 410855 0
1. Pre-training (week 1) to immediate post-training (week 8)
2. Pre-training (week 1) to follow-up (week 14)

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.
Minimum age
5 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
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
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/07/2022
Actual
9/06/2022
Date of last participant enrolment
Anticipated
29/07/2022
Actual
20/07/2022
Date of last data collection
Anticipated
28/10/2022
Actual
15/12/2022
Sample size
Target
100
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311644 0
Charities/Societies/Foundations
Name [1] 311644 0
The Ian Potter Foundation
Country [1] 311644 0
Australia
Primary sponsor type
Individual
Name
Dr Hannah Kirk
Address
Room 504, 18 Innovation Walk,
Monash University,
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 313088 0
None
Name [1] 313088 0
Address [1] 313088 0
Country [1] 313088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311099 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 311099 0
Ethics committee country [1] 311099 0
Australia
Date submitted for ethics approval [1] 311099 0
08/11/2019
Approval date [1] 311099 0
19/12/2019
Ethics approval number [1] 311099 0
22515
Ethics committee name [2] 311102 0
Department of Education and Training
Ethics committee address [2] 311102 0
Ethics committee country [2] 311102 0
Australia
Date submitted for ethics approval [2] 311102 0
20/12/2019
Approval date [2] 311102 0
04/02/2020
Ethics approval number [2] 311102 0
2019_004263

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

Contacts
Principal investigator
Name 119942 0
Dr Hannah Kirk
Address 119942 0
18 Innovation Walk
Monash University
Wellington Rd
Clayton VIC 3800
Country 119942 0
Australia
Phone 119942 0
+61 3 9905 0230
Fax 119942 0
Email 119942 0
[email protected]
Contact person for public queries
Name 119943 0
Hannah Kirk
Address 119943 0
18 Innovation Walk
Monash University
Wellington Rd
Clayton VIC 3800
Country 119943 0
Australia
Phone 119943 0
+61 3 9905 0230
Fax 119943 0
Email 119943 0
[email protected]
Contact person for scientific queries
Name 119944 0
Hannah Kirk
Address 119944 0
18 Innovation Walk
Monash University
Wellington Rd
Clayton VIC 3800
Country 119944 0
Australia
Phone 119944 0
+61 3 9905 0230
Fax 119944 0
Email 119944 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
After August 2023
No end date
Available to whom?
Open access to all on the Open Science Framework
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.
How or where can data be obtained?
Open Science Framework - https://osf.io/wt3s2


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16384Study protocolThe 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  
16385Statistical analysis planThe 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  
16386Informed consent form    384221-(Uploaded-15-06-2022-16-34-36)-Study-related document.pdf
16388Ethical approval    384221-(Uploaded-15-06-2022-16-30-40)-Study-related document.pdf
16389Analytic codeThe 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  
19990Clinical study reportThe 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.