Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12618001709235
Ethics application status
Approved
Date submitted
12/10/2018
Date registered
16/10/2018
Date last updated
24/09/2019
Date data sharing statement initially provided
24/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
action video game training in children with dyslexia
Scientific title
Action video game training for reading in children with dyslexia: A randomized controlled trial
Secondary ID [1] 296186 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dyslexia 309810 0
specific reading disorder 309811 0
reading impairment 309812 0
poor reading 309813 0
Condition category
Condition code
Mental Health 308608 308608 0 0
Learning disabilities
Neurological 308805 308805 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The action video game (AVG) used will be the app 'Fruit Ninja'. This game requires participants to 'slice' as many fruit as possible. The idea is to increase the speed and accuracy of spatial and temporal attentional shifting.The Fruit Ninja app was selected on the basis that it follows the checklist developed by Green, Li, and Bavelier (2010) as having all four qualitative features of an AVG - 1) having extraordinary speed in terms of transient events and velocity of moving objects; 2) a high degree of perceptual, cognitive, and motor load with an accurate motor plan; 3) spatial and temporal unpredictability; 4) emphasis on peripheral processing.

There will be two AVG treatment groups. Adapted (eye-movement-controlled) and un-manipulated versions of the Fruit Ninja app will be utilized as the two AVG training protocols. In the un-manipulated version, participants use a computer mouse to 'slice' the fruit by moving the mouse across the fruit. In the adapted version, participants will be required to use their eye movements (monitored by the Gaze Point eye-tracker) to 'slice' the fruit by making saccades across the fruit. Individual games vary in length depending on the mini-game being played, and how successful the participant is in avoiding the 'bombs' and slicing all fruit. In the eye-movement-controlled version, conceptually and ecologically, the task performance should also be greatly reliant on fast efficient eye-movements. Children will be trained in small groups (3-4 children per group) at schools for 30 minutes per day, 5 days per week, for 2 weeks. Training will be overseen and administered by a psychologist with assistance from postgraduate research students.
Intervention code [1] 312511 0
Treatment: Other
Comparator / control treatment
The control group will receive standard care from their schools (i.e., additional reading support and instruction). It is important to note that those in the control group were eligible to complete one of the AVG interventions following their participation in the 'Time 2' outcome assessments.
Control group
Active

Outcomes
Primary outcome [1] 307574 0
York Assessment of Reading for Comprehension (YARC; Australian edition)
Timepoint [1] 307574 0
Time 1 (1 week before training period); Time 2 (1 week following training period)
Primary outcome [2] 307575 0
Comprehensive Test of Phonological Processing 2 (CTOPP-2) Rapid Letter Naming & Rapid Number Naming subtests
Timepoint [2] 307575 0
Time 1 (1 week before training period); Time 2 (1 week following training period)
Secondary outcome [1] 352336 0
FastaReada (Elhassan, Crewther, Bavin & Crewther, 2015).
Timepoint [1] 352336 0
Time 1 (1 week before training period); Time 2 (1 week following training period)
Secondary outcome [2] 352337 0
Flicker Fusion (Brown, Corner, Crewther, & Crewther, 2018)
Timepoint [2] 352337 0
Time 1 (1 week before training period); Time 2 (1 week following training period)
Secondary outcome [3] 352338 0
Flickering E (Kiely, Crewther, & Crewther, 2007)
Timepoint [3] 352338 0
Time 1 (1 week before training period); Time 2 (1 week following training period)
Secondary outcome [4] 352339 0
Inspection Time (Brown & Crewther, 2015)
Timepoint [4] 352339 0
Time 1 (1 week before training period); Time 2 (1 week following training period)
Secondary outcome [5] 352340 0
Eye movements (recorded using gazepoint 150Hz eye tracker) during rapid naming
Timepoint [5] 352340 0
Time 1 (1 week before training period); Time 2 (1 week following training period)

Eligibility
Key inclusion criteria
Children who meet criteria for specific learning disorder in reading (i.e., dyslexia) according to standard diagnostic criteria (DSM-5).
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
uncorrected visual abnormalities, neurodevelopmental, neurological, psychiatric and medical disorders other than Dyslexia (also referred to as specific learning disorder in reading OR reading disorder).

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)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised random 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
Separate MANCOVA’s will be used to determine differences between the three groups (un-manipulated AVG training, eye-movement-controlled AVG training, control group) while co-varying for time (scores at baseline assessment), on the dependent variables - 1) reading ability (accuracy, rate, comprehension, fluency); 2) rapid naming (CTOPP-2); 3) visuo-attention (as measured by inspection time, flicker fusion and flickering E tasks); and 4) eye movements.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/10/2017
Date of last participant enrolment
Anticipated
31/01/2019
Actual
1/11/2018
Date of last data collection
Anticipated
28/02/2019
Actual
30/11/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300775 0
University
Name [1] 300775 0
La Trobe University
Country [1] 300775 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Department of Psychology and Counselling, La Trobe University VIC 3086
Country
Australia
Secondary sponsor category [1] 300324 0
None
Name [1] 300324 0
Address [1] 300324 0
Country [1] 300324 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301558 0
La Trobe Univeristy Human Ethics Commitee
Ethics committee address [1] 301558 0
Ethics committee country [1] 301558 0
Australia
Date submitted for ethics approval [1] 301558 0
15/11/2016
Approval date [1] 301558 0
13/12/2016
Ethics approval number [1] 301558 0
UHEC16-121

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

Contacts
Principal investigator
Name 87382 0
Ms Jessica Peters
Address 87382 0
Department of Psychology and Counselling, La Trobe University VIC 3086
Country 87382 0
Australia
Phone 87382 0
+61 394792290
Fax 87382 0
Email 87382 0
[email protected]
Contact person for public queries
Name 87383 0
Jessica Peters
Address 87383 0
Department of Psychology and Counselling, La Trobe University VIC 3086
Country 87383 0
Australia
Phone 87383 0
+61 394792290
Fax 87383 0
Email 87383 0
[email protected]
Contact person for scientific queries
Name 87384 0
Jessica Peters
Address 87384 0
Department of Psychology and Counselling, La Trobe University VIC 3086
Country 87384 0
Australia
Phone 87384 0
+61 394792290
Fax 87384 0
Email 87384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not within ethics approval.


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
SourceTitleYear of PublicationDOI
EmbaseAction video game training improves text reading accuracy, rate and comprehension in children with dyslexia: a randomized controlled trial.2021https://dx.doi.org/10.1038/s41598-021-98146-x
N.B. These documents automatically identified may not have been verified by the study sponsor.