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Trial registered on ANZCTR


Registration number
ACTRN12622001334796
Ethics application status
Approved
Date submitted
7/10/2022
Date registered
18/10/2022
Date last updated
20/10/2022
Date data sharing statement initially provided
18/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
COMmon assumptions of cognitivE Training (COMET) Project: A trial evaluating the assumption that working memory training should comprise variations of the training activities in children aged 7-11 years
Scientific title
COMmon assumptions of cognitivE Training (COMET) Project: A randomised controlled trial of working memory training with one, two or three variations of the training activities, for working memory in children aged 7-11 years
Secondary ID [1] 307853 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
working memory 327465 0
non-verbal reasoning 327466 0
inattention and hyperactivity-impulsivity behaviour 327467 0
Condition category
Condition code
Mental Health 324592 324592 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The COMET project evaluates common assumptions of working memory training interventions using an experimental working memory training intervention designed and developed specifically for the project. The intervention and its delivery were co-designed with developmental cognitive scientists with input from teachers, parents and primary school children. This approach ensures the design of the intervention is scientifically rigorous, including common design features of current cognitive training interventions considered effective at improving children's working memory, and also ensures both the intervention and its delivery are acceptable and feasible to teachers, caregivers and primary school children so that it is engaging and can be used in the classroom.

In this trial the working memory training intervention comprises two experimental working memory activities that are gamified and involve the temporary storage and manipulation of verbally presented target information: a backward span activity and a following instructions activity. For each activity, the difficulty will be adapted to the child's performance, with all children starting the first session at the same level and then the difficulty of a trial will be based on the child's previous performance. The child completes both activities in each session. Motivating features of the intervention include the story line across the training sessions, and collecting experience points while completing the activities which can be used at the end of each session to build in the worlds. For each participating child, the data for each training session will be uploaded and will enable researchers to monitor adherence to the intervention.

The intervention schedule will involve completing a total of 10 sessions of 20 minutes duration, performed each school day for 2 consecutive weeks. It will be delivered by the teacher in class. Each child will individually perform the intervention on an iPad with headphones provided by the researchers.

All teachers will be provided one handout summarising key information about the intervention and its delivery, including the storyline, schedule, how to log in, instructions such as students watch the information video on their iPad at the start of session 1, and contact details for any questions.

In this trial the working memory training intervention has three arms, which differ in the number of variations of each training activity:
Arm 1 - Two activities, where the trainee practices on one backward span activity and one following instructions activity within each training sessions.
Arm 2 - Four activities, where the trainee practices on two variations of the backward span activity and two variations of following instructions activity within each training session.
Arm 3 - Six activities, where the trainee practices on three variations of the backward span activity and three variations of the following instructions activity within each training session.

Participants will be randomly allocated to one of the three arms based on a randomisation scheme that will be generated in advance and set up in REDCap. To randomise a participant, an authorised research team member will login to REDCap, enter eligibility and stratification data on the participant, and will receive the group allocation. User access restrictions will prevent anyone outside of the trial statistician from setting up or viewing the allocation sequence prior to a participant being randomised.
Intervention code [1] 324320 0
Treatment: Devices
Comparator / control treatment
In this project the active control will consist of gamified creative activities embedded in the same context as the working memory training activities and includes the same motivating features, and may therefore serve as a placebo. The control activities were designed based on review of current gamified activities that primary school teachers are currently using in the classroom as part of their usual teaching, for children in the project's age range, and that do not require working memory.

In this trial the control comprises creative building and discovery activities. The child completes a different activity in each session.

The active control schedule will involve completing a total of 10 sessions of 20 minutes duration, performed each school day for 2 consecutive weeks. It will be delivered by the teacher in class. Each child will individually perform the active control on an iPad with headphones provided by the researchers.

All teachers will be provided one handout summarising key information about the intervention and its delivery (the same for the working memory training and active control conditions to maintain blinding), including the storyline, schedule, how to log in, instructions such as students watch the information video on their iPad at the start of session 1, and contact details for any questions.
Control group
Active

Outcomes
Primary outcome [1] 332412 0
Working memory performance assessed using a task similar in structure to a training activity: backward span task with digits as stimuli
Timepoint [1] 332412 0
Immediately post-intervention completion
Primary outcome [2] 332413 0
Working memory performance assessed using a task similar in structure to a training activity: following instructions task with objects as stimuli
Timepoint [2] 332413 0
Immediately post-intervention completion
Secondary outcome [1] 413414 0
Working memory performance assessed using a task similar in structure to a training activity: backward span task with digits as stimuli
Timepoint [1] 413414 0
6-months post-intervention completion
Secondary outcome [2] 413415 0
Working memory performance assessed using a task similar in structure to a training activity: following instructions task with objects as stimuli
Timepoint [2] 413415 0
6 months post-intervention completion
Secondary outcome [3] 413416 0
Working memory performance assessed using a task similar in structure to a training activity: backward span task with letters as stimuli
Timepoint [3] 413416 0
Immediately post-intervention and 6 months immediately post-intervention completion
Secondary outcome [4] 413417 0
Working memory performance assessed using a task similar in structure to a training activity: following instructions task with letters as stimuli
Timepoint [4] 413417 0
Immediately post-intervention completion and 6 months post-intervention completion
Secondary outcome [5] 413418 0
Working memory performance assessed using a task different in structure to a training activity: n-back task with objects as stimuli
Timepoint [5] 413418 0
Immediately post-intervention completion and 6 months post-intervention completion
Secondary outcome [6] 413419 0
Non-verbal reasoning assessed using the Raven's Standard Progressive Matrices
Timepoint [6] 413419 0
Immediately post-intervention completion and 6-months post-intervention completion
Secondary outcome [7] 413420 0
Inattention and hyperactivity-impulsivity symptoms assessed using the ADHD Rating Scale-5 home version
Timepoint [7] 413420 0
Immediately post-intervention completion and 6-months post-intervention completion

Eligibility
Key inclusion criteria
Children aged 7 to 11 years (Grade 2, 3, 4 and 5 classes) at the participating primary school (within 20km of Monash University) whose caregiver consents for their child to participate in baseline and outcome testing
Minimum age
7 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Vision impairment that can not be corrected by glasses, hearing impairment that can not be corrected by hearing aid, fine motor impairment, and/or intellectual disability based on parent report, which would prevent participation in the working memory training intervention, control or cognitive testing.

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)
The randomisation scheme will be generated in advance and set up in REDCap. To randomise a participant, an authorised research team member will login to REDCap, enter eligibility and stratification data on the participant, and will receive the group allocation. User access restrictions will prevent anyone outside of the trial statistician from setting up or viewing the allocation sequence prior to a participant being randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomised into groups using a complete randomisation scheme generated in advance. Specifically, block sizes of variable size (4 or 8) will be used to assure allocation concealment and pre-guessing of the allocation sequence at the end of each block. Randomisation will be stratified by age (7 to 8; 9 to 10; 11 to 12 years).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analyses will be based on an intention-to-treat approach and secondary analyses will involve only those children who completed the allocated intervention. Performance on untrained working memory tests immediately post-intervention (primary outcome) as well as performance on tests of related domains (secondary outcomes) immediately and 6-months post-intervention, will be analysed using both traditional null-hypothesis significance testing methods and Bayesian methods, to quantify the strength of evidence in favour of the null hypothesis and the alternative hypothesis. Regressions will be performed to directly test differences between groups on the primary outcome and all secondary outcomes, with the outcome measure entered as the dependent variable and the groups entered as the independent variables. Demographic, stratification and baseline outcome factors may also be included as covariates. Statistical tests will be focused, comparing differences between each of the training conditions relative to the active control. Effect sizes will be reported to demonstrate the magnitude of differences in outcomes between training conditions relative to the active control. Interpretation of results will consider strength of effects as well as relying on p values.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2023
Actual
Date of last participant enrolment
Anticipated
2/06/2023
Actual
Date of last data collection
Anticipated
15/12/2023
Actual
Sample size
Target
175
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312131 0
University
Name [1] 312131 0
Monash University
Country [1] 312131 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Turner Institute for Brain and Mental Health
School of Psychological Sciences
18 Innovation Walk
Clayton, Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 313652 0
None
Name [1] 313652 0
Address [1] 313652 0
Country [1] 313652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311526 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 311526 0
Ethics committee country [1] 311526 0
Australia
Date submitted for ethics approval [1] 311526 0
06/10/2022
Approval date [1] 311526 0
13/10/2022
Ethics approval number [1] 311526 0

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

Contacts
Principal investigator
Name 121410 0
Dr Megan Spencer-Smith
Address 121410 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton, Victoria 3800
Australia
Country 121410 0
Australia
Phone 121410 0
+61 3 9905 9148
Fax 121410 0
Email 121410 0
megan.spencer-smith@monash.edu
Contact person for public queries
Name 121411 0
Megan Spencer-Smith
Address 121411 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton, Victoria 3800
Australia
Country 121411 0
Australia
Phone 121411 0
+613 9905 9148
Fax 121411 0
Email 121411 0
megan.spencer-smith@monash.edu
Contact person for scientific queries
Name 121412 0
Megan Spencer-Smith
Address 121412 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton, Victoria 3800
Australia
Country 121412 0
Australia
Phone 121412 0
+61 3 9905 9148
Fax 121412 0
Email 121412 0
megan.spencer-smith@monash.edu

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 de-identified participant data underlying published results.
When will data be available (start and end dates)?
Immediately following publication of planned manuscripts, available for 5 years after publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (megan.spencer-smith@monash.edu). Appropriate ethical approval is required prior to release.


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.