Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001111460
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
17/08/2016
Date last updated
19/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving attention and learning capacity in early childhood via a computerised cognitive training program: a randomised controlled trial
Scientific title
Improving attention and learning capacity in early childhood via a computerised cognitive training program: a randomised controlled trial
Secondary ID [1] 289823 0
Nil
Universal Trial Number (UTN)
Trial acronym
ICAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficits 299750 0
Condition category
Condition code
Mental Health 299681 299681 0 0
Autistic spectrum disorders
Mental Health 299682 299682 0 0
Learning disabilities
Mental Health 299683 299683 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed intervention is a computerized attention training program called 'The Training Attention and Learning Initiative' (TALI). TALI was designed to develop core attentional processes. The program consists of four activities that target the core attentional processes; such as selective attention, sustained attention, and executive attention/attentional control. TALI is colourful, interactive, and has the capacity to automatically adjust task difficulty to cater for the learning of each child. The TALI software monitors each participant's use by regularly and automatically uploading each participants' deidentified scores.

In the proposed research, TALI is to be used by children on an electronic 'touch' tablet for 20 minutes a day, 5 times a week, over a 5 week period. The program is to be used by children in the school classroom environment.
Intervention code [1] 295566 0
Treatment: Other
Comparator / control treatment
The proposed research will involve participants being randomly allocated to either the intervention condition, an active control, or a passive ‘teach as usual’ control group. The two control conditions are described below:

1. Active control condition
Participants randomly allocated to this condition will complete an active control condition whereby they will be required to use an alternative software package. The alternate software uses the same interactive guides and inbuilt rewards as TALI but was developed to involve minimal attention skills and is non-adaptive.

2. Teach as Usual condition
Participants randomly allocated to this condition will not undergo any form of intervention and will continue to have classes continue as usual.
Control group
Active

Outcomes
Primary outcome [1] 299213 0
The Primary measure is proposed to be the Test of Everyday Attention for Children (TEA-Ch; Manly, Robertson, Anderson, & Nimmo-Smith, 1998). The TEA-Ch assesses the ability of children to selectively attend, sustain their attention, divide their attention between two tasks, switch attention from one task to another, and withhold (inhibit) verbal and motor responses.
Timepoint [1] 299213 0
Attention will be assessed at the baseline, immediately post-intervention, and at 6 months post-intervention time points.
Secondary outcome [1] 326528 0
Working Memory abilities will be assessed using four subtests from the Automated Working Memory Assessment (AWMA: Alloway 2007), a standardised, reliable and valid PC-based assessment designed for ages 4-22 years. Verbal working memory will be estimated by two subtests: (i) Digit Recall, which requires the child to immediately repeat progressively longer sequences of digits presented verbally and (ii) Backward Digit Recall, which requires the child to recall progressively longer sequences of digits in the reverse order to that presented. Visuospatial working memory will be estimated by two subtests: (iii) Dot Matrix, which requires the child to repeat progressively sequences of dots appearing on a 4 x 4 grid and (iv) Mister X, which requires the child to remember and mentally manipulate progressively longer sequences of visually presented information (a cartoon person holding a ball in one of eight compass points). This will show whether cognitive training transfers to improvement on non-trained working memory tasks.
Timepoint [1] 326528 0
Working Memory will be assessed at the baseline, immediately post-intervention, and at 6 months post-intervention time points.
Secondary outcome [2] 326530 0
Vocabulary will be assessed using The Peabody Picture Vocabulary Test – fourth edition (PPVT- 4; Dunn & Dunn, 2007) was used to assess receptive vocabulary skills. Children are presented with a series of pictures and asked to identify a word specified by the examiner by pointing to the corresponding image, from a choice of four pictures. Participant’s responses were recorded and the experimenter progressed through each trial until discontinue criteria was met (8 or more incorrect errors in a set of 12 trials).
Timepoint [2] 326530 0
Vocabulary will be assessed at the baseline, immediately post-intervention, and at 6 months post-intervention time points.
Secondary outcome [3] 326534 0
Mathematical abilities will be assessed using The Test of Early Mathematics Ability III (TEMA-III; Ginsburg & Baroody, 2003) was used to assess a wide range of mathematical abilities, such as numbering skills, counting, number comparisons, calculation skills and understanding concepts. This measure contains 72 items and the experimenter progressed through these items until discontinue criteria was met (5 consecutive incorrect responses).
Timepoint [3] 326534 0
Mathematical abilities will be assessed at the baseline, immediately post-intervention, and at 6 months post-intervention time points.
Secondary outcome [4] 326535 0
General cognitive ability will be estimated using the Kaufman Brief Intelligence Test - Second Edition (KBIT-2: Kaufman & Kaufman 2004), a standardised, reliable and valid assessment designed for 4-90 years. Two subtests yield a Verbal Scale: (i) Verbal Knowledge, which requires the child to point to the picture that best illustrates a word or answer to a general knowledge questions about the world that becomes increasingly difficult and (ii) Riddles, which requires the child to listen to riddles that become increasingly and point to the picture from a set of options that answers the riddle. One subtest yields a Nonverbal Scale: (iii) Matrices, which requires the child to look at a picture or design with a piece missing and point to the piece from a set of options that would complete the picture. An IQ score is calculated based on the Verbal and Nonverbal Scales.
Timepoint [4] 326535 0
General cognitive ability will be estimated at the baseline time point only.
Secondary outcome [5] 326536 0
Parents and the class teachers of participants will be administered the Strengths and Weaknesses of ADHD symptoms and Normal behaviour (SWAN). The SWAN is a measure of inattention and hyperactivity.
Timepoint [5] 326536 0
Behavioural Parent and Teacher measures of attention will be assessed at the baseline, immediately post-intervention, and at 6 months post-intervention time points.

Eligibility
Key inclusion criteria
All enrolled children within the junior grades (Preschool, Prep, Year 1, or Year 2) within the randomly allocated mainstream schools will be eligible to participate.
Minimum age
4 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if their estimated IQ scores are found to be below the standardised score of 75.

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)
During the recruitment process research staff involved will be unaware of the experimental condition to which the participants will be allocated. Allocation will involve contacting the holder of the allocation schedule who will be off site and at a central administration center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will occur using a computerised sequence generation. Random allocation will be clustered into schools.
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
Efficacy
Statistical methods / analysis
Outcome data will be screened, cleaned and analysed to determine if children who received the TALI program showed significantly greater improvements in cognitive and academic skills compared to children who received the control program or no program. Performance on each of the outcome measures will be assessed across each of the three time points and across each of the three groups using regression analysis. This type of analysis allows us to assess if children’s performance improves over time but also if a particular group has significantly greater improvements over time.

A priori power analysis using G*Power indicated that there was a 83% chance of detecting a medium effect size on our outcomes measures with a total sample of 36 children (n=12 in each of the groups) and a 80% chance of detecting a small effect size with a total sample of 201 children (n=67 in each of the groups). Based on these calculations and the feasibility of recruiting children to be involved in the trial, a total sample of 120 children (n=40 in each group) was deemed adequate to detect small to medium effects on the outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2016
Actual
17/10/2016
Date of last participant enrolment
Anticipated
7/10/2016
Actual
11/11/2016
Date of last data collection
Anticipated
17/03/2017
Actual
23/06/2017
Sample size
Target
120
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13978 0
3147 - Ashburton
Recruitment postcode(s) [2] 13979 0
3125 - Burwood
Recruitment postcode(s) [3] 13980 0
3148 - Chadstone
Recruitment postcode(s) [4] 13981 0
3168 - Clayton
Recruitment postcode(s) [5] 13982 0
3150 - Brandon Park
Recruitment postcode(s) [6] 13983 0
3166 - Hughesdale
Recruitment postcode(s) [7] 13985 0
3149 - Mount Waverley
Recruitment postcode(s) [8] 13986 0
3170 - Mulgrave
Recruitment postcode(s) [9] 13987 0
3168 - Notting Hill
Recruitment postcode(s) [10] 13988 0
3166 - Huntingdale
Recruitment postcode(s) [11] 13989 0
3167 - Oakleigh South
Recruitment postcode(s) [12] 13990 0
3150 - Glen Waverley
Recruitment postcode(s) [13] 13991 0
3101 - Kew

Funding & Sponsors
Funding source category [1] 294257 0
Commercial sector/Industry
Name [1] 294257 0
TALI Health Pty Ltd.
Country [1] 294257 0
Australia
Funding source category [2] 294258 0
Government body
Name [2] 294258 0
Department of Industry, Innovation and Science
Country [2] 294258 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University Clayton Campus,
Wellington Rd & Blackburn Rd,
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 293089 0
None
Name [1] 293089 0
Address [1] 293089 0
Country [1] 293089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295684 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 295684 0
Ethics committee country [1] 295684 0
Australia
Date submitted for ethics approval [1] 295684 0
Approval date [1] 295684 0
15/11/2012
Ethics approval number [1] 295684 0
CF12/2779 - 212001505
Ethics committee name [2] 295685 0
Victorian Department of Education
Ethics committee address [2] 295685 0
Ethics committee country [2] 295685 0
Australia
Date submitted for ethics approval [2] 295685 0
08/08/2016
Approval date [2] 295685 0
Ethics approval number [2] 295685 0
Ethics committee name [3] 295686 0
Catholic Education Melbourne
Ethics committee address [3] 295686 0
Ethics committee country [3] 295686 0
Australia
Date submitted for ethics approval [3] 295686 0
08/08/2016
Approval date [3] 295686 0
Ethics approval number [3] 295686 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1004 1004 0 0
/AnzctrAttachments/371223-EthicsApproval.pdf

Contacts
Principal investigator
Name 67950 0
Dr Hannah Kirk
Address 67950 0
Room 425, Level 4
School of Psychological Sciences,
18 Innovation Walk,
Monash University, Clayton
VIC 3800.
Country 67950 0
Australia
Phone 67950 0
+61 3 8888 1043
Fax 67950 0
Email 67950 0
[email protected]
Contact person for public queries
Name 67951 0
Hannah Kirk
Address 67951 0
Room 425, Level 4
School of Psychological Sciences,
18 Innovation Walk,
Monash University, Clayton
VIC 3800.
Country 67951 0
Australia
Phone 67951 0
+61 3 8888 1043
Fax 67951 0
Email 67951 0
[email protected]
Contact person for scientific queries
Name 67952 0
Hannah Kirk
Address 67952 0
Room 425, Level 4
School of Psychological Sciences,
18 Innovation Walk,
Monash University, Clayton
VIC 3800.
Country 67952 0
Australia
Phone 67952 0
+61 3 8888 1043
Fax 67952 0
Email 67952 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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