Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000852651
Ethics application status
Approved
Date submitted
31/07/2014
Date registered
8/08/2014
Date last updated
8/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the Effect of Working Memory Training on Academic Achievement in School Children
Scientific title
Examining the Effect of Working Memory Training on Academic Achievement in School Children
Secondary ID [1] 285083 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Academic Achievement 292614 0
Condition category
Condition code
Mental Health 292932 292932 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We complete an examination of computerised working memory training. The study consists of three conditions, or arms: Active (Arm 1), Placebo (Arm 2), Control (Arm 3).

Active condition: We used the RM (i.e., school age) version of Cogmed Working Memory Training (Cogmed, 2014). Cogmed RM is a computerised training program, which requires children to complete a number of interactive visuo-spatial tasks each day. Each game requires the child to hold and manipulate information in working memory. For example, in one of the games, blocks on the screen will momentarily glow, one at a time, in a certain order. The child is required to remember the order, and then select the lit blocks in the reverse order.

Trials within the training program are scaffolded to the participant’s ability, matching the difficulty of trials to the child’s ongoing performance. Participants completed the computerised training every school day for five weeks. Each training session took approximately 45 minutes, and was completed in a computer laboratory of the child’s school, under the supervision of a teacher. We attempted to train 4 class teachers in the web-based Coach training provided by Cogmed, however, two teachers reported that the training was too difficult and did not complete the program. As a result, teachers were trained as training aides by the first author, who also oversaw the technical administration of training.
Intervention code [1] 289922 0
Behaviour
Comparator / control treatment
Placebo condition: A low level, unscaffolded version of Cogmed training was used as a placebo. The training program involves the same tasks as the active version completed and is also completed on a daily basis for five weeks, however, the difficulty of trials remains constant. A much discussed limitation of the placebo version of Cogmed is the discrepancy in training time between active and placebo conditions. Specifically, training time is consistently lower in the placebo version of training (Chacko, Bedard, et al., 2013). In order to approximate the conditions’ training time and contact with the supportive adult, it has been suggested that the number of trials is increased in the placebo version. As previous attempts to increase training time on a case-by-case basis have been unsuccessful (Chacko, Bedard, et al., 2013), we increased the training weight by 30% for all participants in the placebo condition at the beginning of training. This increases the number of trials completed for each session.

Control condition: No further contact with researchers during the five-week training time.
Control group
Placebo

Outcomes
Primary outcome [1] 292794 0
Academic Achievement
Mathematics: Normed score on the Progressive Achievement Test of Mathematics.
Reading Comprehension: Normed score on the Progressive Achievement Test of Reading.
Timepoint [1] 292794 0
Timepoint: pre-intervention, post-intervention, three months after intervention
Secondary outcome [1] 309695 0
Behaviour difficulties, recorded on the Child Behaviour Checklist (CBCL) by parents (Parent-report CBCL) and teachers (Teacher-report CBCL).
Timepoint [1] 309695 0
Timepoint: pre-intervention, post-intervention, three months after intervention

Eligibility
Key inclusion criteria
Year 6 or Year 7 student
Attending a government primary school
Completing schooling in English
Minimum age
9 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Persistent non attendance at school

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)
We employed a cluster randomised controlled design. After school principals had given consent, each class of students was randomly allocated to control, active or placebo using a random number generation chart. This process was performed by the lead researcher. Trial eligibility for each student was assessed by the class teacher, who was blind to condition allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number chart will be used to allocate to condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Counterbalancing of assessment sessions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined by calculations of statistical power. Thirty three participants per condition is recommended to detect a medium effect (d = 0.5) with power of .80 (Cohen, 1988; Rosenthal & Rosnow, 2008). We therefore aimed to recruit a minimum of 33 participants per condition to ensure adequate power.

Our hypotheses will be analysed using Analysis of Variance (ANOVAs). A series of linear regressions using bootstrapping procedures will also be completed to determine the hypothesised mediation effects.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2014
Actual
1/05/2014
Date of last participant enrolment
Anticipated
7/05/2014
Actual
7/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
99
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 8485 0
5045 - Glenelg
Recruitment postcode(s) [2] 8486 0
5048 - Brighton

Funding & Sponsors
Funding source category [1] 289688 0
Other
Name [1] 289688 0
ARC Science of Learning Research Centre
Country [1] 289688 0
Australia
Primary sponsor type
Other
Name
ARC-SRI: Science of Learning Research Centre
Address
Science of Learning Research Centre
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 288383 0
None
Name [1] 288383 0
Address [1] 288383 0
Country [1] 288383 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291429 0
Flinders University Social and Behavioural research Ethics committee
Ethics committee address [1] 291429 0
Ethics committee country [1] 291429 0
Australia
Date submitted for ethics approval [1] 291429 0
Approval date [1] 291429 0
20/03/2014
Ethics approval number [1] 291429 0
6414
Ethics committee name [2] 291430 0
Department of Education and Child Development
Ethics committee address [2] 291430 0
Ethics committee country [2] 291430 0
Australia
Date submitted for ethics approval [2] 291430 0
Approval date [2] 291430 0
25/03/2014
Ethics approval number [2] 291430 0
DECD CS/14/511-8

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

Contacts
Principal investigator
Name 50330 0
Dr Caitlin Hitchcock
Address 50330 0
Science of Learning Research Centre (Science21)
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 50330 0
Australia
Phone 50330 0
+61882012316
Fax 50330 0
Email 50330 0
[email protected]
Contact person for public queries
Name 50331 0
Caitlin Hitchcock
Address 50331 0
Science of Learning Research Centre (Science21)
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 50331 0
Australia
Phone 50331 0
+61882012316
Fax 50331 0
Email 50331 0
[email protected]
Contact person for scientific queries
Name 50332 0
Caitlin Hitchcock
Address 50332 0
Science of Learning Research Centre (Science21)
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 50332 0
Australia
Phone 50332 0
+61882012316
Fax 50332 0
Email 50332 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.