Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000016538
Ethics application status
Approved
Date submitted
3/12/2014
Date registered
14/01/2015
Date last updated
29/08/2019
Date data sharing statement initially provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Computerised Training on Academic Achievement in Primary School Students
Scientific title
The effects of computerised cognitive training on executive function, academic achievement and fluid intelligence in Year 3 and Year 5 students: A randomised clinical trial.
Secondary ID [1] 285780 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Executive Functioning 293663 0
Fluid Reasoning 293664 0
Academic Achievement 293665 0
Condition category
Condition code
Mental Health 293961 293961 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research will test the efficacy of a computerised cognitive training program. The training program runs 5 days per week for 6.5 weeks with 1 x 20 minute session per day. The training will be completed in a classroom with the researcher providing instructions and supervising administration. Progress of individual participants can be monitored by the researcher using an online portal.

The training program involves the completion of a number of game-like cognitive training programs (e.g. selecting a picture that matches a pre-determined rule; selecting coloured balls based on a pre-determined rule; selecting an appropriate card to complete a pattern).

One year after the training is completed, the whole training process is completed over again using the same procedure as outlined above.
Intervention code [1] 290739 0
Other interventions
Comparator / control treatment
A computerised touch-typing training program as the control group intervention. The program instructs participants how to touch-type using the correct posture and finger position. It is a graded program that begins with the easier keys and progresses to more complex typing tasks (e.g. capital letters, numbers and symbols).

The control group intervention runs in the same manner as the experimental group: 5 days per week for 6.5 weeks with 1 x 20 minute session per day. The training will be completed in a classroom with the researcher providing instructions and supervising administration. Progress of individual participants can be monitored by the researcher using an online portal.

One year after the training is completed, the whole training process is completed over again using the same procedure as outlined above.
Control group
Active

Outcomes
Primary outcome [1] 293734 0
Executive Function Scores based upon 3 tasks each for Working Memory (Reading Span Task; Operation Span Task, Symmetry Span Task), Shifting Ability (Switcher Test, Connections Test, Card Sorting Test) and Inhibition (Flanker Test, Go No-Go Test, Numerical Stroop Test).
Timepoint [1] 293734 0
Pre- and Post-training assessments, then again one year after training this is repeated (pre- and post-assessments & retraining).
Primary outcome [2] 293735 0
Academic Achievement as measured by the Progressive Achievement Tests (Maths & Reading).
Timepoint [2] 293735 0
Pre-training assessment and then one year later.
Primary outcome [3] 293736 0
Fluid Reasoning Measure (Naglieri Non-verbal Achievement Test)
Timepoint [3] 293736 0
Pre- and post-training assessment and then repeated again one year later (pre- and post-training assessment & retraining)
Secondary outcome [1] 311697 0
Implicit Theory of Intelligence measure (survey)
Timepoint [1] 311697 0
Pre-training assessment
Secondary outcome [2] 311698 0
Behavioural observation by teacher and parent of executive functioning abilities (using the Comprehensive Executive Functioning Inventory).
Timepoint [2] 311698 0
Pre- and post-training assessment and then repeated one year later (pre- and post-training assessment & retraining).
Secondary outcome [3] 311699 0
Improvement expectancy measure (survey assessment). This measure has been designed specifically for this study.
Timepoint [3] 311699 0
Given one week after the commencement of training course.

Eligibility
Key inclusion criteria
A random sample of Year 3 and Year 5 students from a boys-only school.
Minimum age
7 Years
Maximum age
12 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous research using sample sizes of 20-30 for the experimental group has found effect sizes for near transfer (i.e. working memory) in the range 0.41 to 4.66. However, the same sample sizes for far transfer (i.e. academic achievement, fluid reasoning) have found non-significant (p>0.05) small effect sizes (~0.25). It has been suggested that this is due to small sample sizes and a lack of power. Therefore, this research will use larger sample sizes to pick up the effect of training on far transfer.

Data analysis will determine if there is a treatment effect on executive function dependent variables by using latent growth modelling. Latent growth models use structural equation modelling techniques to model trajectories of change, assess effects of treatment, and consider the relationships among multiple outcome variables and multiple time points simultaneously (Stull et al., 2011). As outlined by Muthen and Curran (1997), the effect of treatment is assessed by comparing the set of trajectories in the treatment population with those in the control population.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
21/04/2015
Date of last participant enrolment
Anticipated
10/10/2017
Actual
28/08/2017
Date of last data collection
Anticipated
24/09/2018
Actual
6/11/2018
Sample size
Target
100
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9011 0
2061 - Milsons Point

Funding & Sponsors
Funding source category [1] 290342 0
Self funded/Unfunded
Name [1] 290342 0
David Hegarty
Country [1] 290342 0
Australia
Primary sponsor type
University
Name
University of Sydney, Dr Paul Ginns
Address
A35 Education Building
University of Sydney
Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 289064 0
None
Name [1] 289064 0
Address [1] 289064 0
Country [1] 289064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292046 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 292046 0
Ethics committee country [1] 292046 0
Australia
Date submitted for ethics approval [1] 292046 0
Approval date [1] 292046 0
28/11/2014
Ethics approval number [1] 292046 0
2014/780

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

Contacts
Principal investigator
Name 53242 0
Dr Paul Ginns
Address 53242 0
Room 914
A35 Education Building
University of Sydney
Sydney, NSW 2006
Country 53242 0
Australia
Phone 53242 0
+61293512611
Fax 53242 0
Email 53242 0
[email protected]
Contact person for public queries
Name 53243 0
David Hegarty
Address 53243 0
The King's School
87-129 Pennant Hills Road
North Parramatta 2151
Country 53243 0
Australia
Phone 53243 0
+61414627911
Fax 53243 0
Email 53243 0
[email protected]
Contact person for scientific queries
Name 53244 0
David Hegarty
Address 53244 0
The King's School
87-129 Pennant Hills Road
North Parramatta 2151
Country 53244 0
Australia
Phone 53244 0
+61414627911
Fax 53244 0
Email 53244 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?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
The data will be available as soon as the thesis is published. There is no end date at this point.
Available to whom?
Anyone who wishes to access it via a link within the thesis.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via github


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.