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Trial registered on ANZCTR


Registration number
ACTRN12612000124831
Ethics application status
Approved
Date submitted
25/01/2012
Date registered
25/01/2012
Date last updated
20/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of an adaptive working memory training intervention in very preterm children: The IMPRINT study
Scientific title
The IMPRINT study: A randomised controlled trial of Cogmed (adaptive working memory training intervention) to reduce academic difficulties in extremely preterm children aged 7.
Secondary ID [1] 279756 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
IMPRINT - IMPROVING MEMORY IN A PRETERM RANDOMISED INTERVENTION TRIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Academic deficits in extremely preterm children 285624 0
Condition category
Condition code
Reproductive Health and Childbirth 285816 285816 0 0
Complications of newborn
Mental Health 285860 285860 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cogmed is an adaptive and intensive training of working memory. It is a computer-based intervention involving 25 sessions of approximately 35 minutes to be undertaken over a 5-7 week period. It comprises a series of interactive games with a reward system to motivate children and assist with compliance.
Intervention code [1] 284076 0
Prevention
Intervention code [2] 284118 0
Treatment: Other
Comparator / control treatment
Placebo group who will receive a computer program identical to the intervention program except that it is not adaptive. in other words, it is set to a low level of difficulty which does not increase with improved mastery.
Control group
Placebo

Outcomes
Primary outcome [1] 286328 0
The primary outcome of this trial is academic performance 2 years post intervention.
Academic outcome will be assessed using the Wide Range Achievement Test -4th edition (WRAT-4). The WRAT-4 includes subtests that assess reading (single word decoding), sentence comprehension, spelling and math computation. Additional information regarding literacy and numeracy, academic performance, grade repetition and integration assistance will be sought from parents and teachers.
Timepoint [1] 286328 0
2 years post intervention commencement
Secondary outcome [1] 295612 0
Working memory will be assessed subtests from the Working Memory Test Battery for Children (WMTB-C):
- Verbal short-term memory will be assessed with Digit Recall and Word List Recall which requires the child to immediately recall verbal information.
- Visual-spatial short-term memory will be assessed with Block Recall and Mazes Memory which involves the child to immediately recall visual-spatial information. A subtest from the Automated Working Memory Assessment (AWMA) known as Mister X will also be used to assess visuo-spatial working memory.
- Verbal working memory will be assessed with Backward Digit Recall which involves the child to recall sequences of digits in the reverse order to that presented.
- Visual-spatial working memory will be assessed with Backward Block Recall which involves the child to recall sequences of tapped blocks in the reverse order to that presented.
Timepoint [1] 295612 0
2 weeks, 12 months and 24 months post-intervention commencement
Secondary outcome [2] 295673 0
Academic outcomes will be assessed using the Wide Range Achievement Test -4th edition (WRAT-4); as previously discussed in primary outcome
Timepoint [2] 295673 0
2 weeks and 12 months post intervention commencement
Secondary outcome [3] 295674 0
Attention will be assessed using subtests from the Test of Everyday Attention for Children (TEACh):
- Sky Search (selective attention)
- Score! (sustained attention)
- Creature Counting (Shifting attention)
Timepoint [3] 295674 0
2 weeks, 12 months and 24 months post-intervention commencement
Secondary outcome [4] 295675 0
Neuroimaging (functional MRI and diffusion tensor imaging) will be performed on a Siemens 3 Tesla Trio MRI scanner:
- Functional MRI: will administer a widely used working memory fMRI paradigm, the N-back task, utilising a visuo-spatial variant of this task with two levels of working memory load (low and high). The visuo-spatial N-back task was selected as it is independent of language ability and is not dependent on native language processing.
- Diffusion tensor imaging: Diffusion images will be analysed using the multi-tensor model, and probabilistic tractography. White matter fibre tracts previously shown to relate to working memory will be identified, including the superior longitudinal fasciculus and cingulum bundle. Tract volume and measures of axonal density (fractional anisotropy (FA) and axial diffusivity (AD)) will be recorded within these tracts of interest.
Timepoint [4] 295675 0
2 weeks following intervention commencement

Eligibility
Key inclusion criteria
Part of the 2005 Victorian Infant Collaborative Study (VICS) cohort (children born <28 weeks gestational age and/or birth weight <1,000 grams).
Minimum age
6 Years
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
severe intellectual/sensory/physical disability

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible families who are willing to participate and have consented will be randomised to either the adaptive working memory training (intervention) group or the placebo group.
Randomisation will be via opaque envelopes managed by the project co-ordinator. The project co-ordinator will open the envelope to obtain the treatment allocation, which will remain blinded to the participant, their family and all other members of the trial team.
The project coordinator is responsible for administering and setting up the intervention therefore cannot be blinded to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A bio-statistician who is independent of study management will oversee the generation of study numbers and treatment allocations.
Block randomisation using variable block sizes will be used to generate treatment allocations. At the time of randomisation, participants will be allocated the next available sequential study number in the required strata. This corresponds to an envelope which will contain the allocation to intervention or placebo group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 4867 0
3052
Recruitment postcode(s) [2] 4870 0
3084
Recruitment postcode(s) [3] 4871 0
3168

Funding & Sponsors
Funding source category [1] 284564 0
Government body
Name [1] 284564 0
National Health and Medical Research Council
Address [1] 284564 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 284564 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Royal Children's Hospital
Flemington Road
Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 283485 0
None
Name [1] 283485 0
Address [1] 283485 0
Country [1] 283485 0
Other collaborator category [1] 260473 0
Other Collaborative groups
Name [1] 260473 0
Victorian Infant Collaborative Study (VICS)
Address [1] 260473 0
Royal Women's Hospital
Department of Obstetrics & Gynaecology
132 Grattan Street
Carlton VIC 3053
Country [1] 260473 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286550 0
Royal Children's Hospital (RCH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 286550 0
Ethics committee country [1] 286550 0
Australia
Date submitted for ethics approval [1] 286550 0
06/02/2012
Approval date [1] 286550 0
21/02/2012
Ethics approval number [1] 286550 0

Summary
Brief summary
Approximately 50% of preterm children born very early have problems at school. Difficulty remembering things, using something technically known as “working memory”, contributes to these school problems. Working memory is the ability to temporarily store information for everyday activities. It is critical for learning information and developing basic academic skills. This study aims to investigate if an adaptive working memory training program, known as Cogmed, can improve school performance in very preterm children at 7 years of age.
It will also be the first study to incorporate advanced neuroimaging techniques in a randomised controlled trial of Cogmed, and will be essential for determining and monitoring the neural changes that occur as a result of adaptive working memory training.
Trial website
N/A
Trial related presentations / publications
No publications to date.
Public notes

Contacts
Principal investigator
Name 33655 0
Prof Peter Anderson
Address 33655 0
Murdoch Childrens Research Institute
50 Flemington Road
Royal Children's Hospital
Parkville, Victoria
3052
Country 33655 0
Australia
Phone 33655 0
+61399366704
Fax 33655 0
Email 33655 0
peter.anderson@mcri.edu.au
Contact person for public queries
Name 16902 0
Prof Peter Anderson
Address 16902 0
Victorian Infant Brain Study (VIBeS),
Murdoch Childrens Research Institute
Royal Children's Hospital
50 Flemington Road, Parkville, VIC, 3052, Australia
Country 16902 0
Australia
Phone 16902 0
+61 3 9936 6704
Fax 16902 0
Email 16902 0
peter.anderson@mcri.edu.au
Contact person for scientific queries
Name 7830 0
Prof Peter Anderson
Address 7830 0
Victorian Infant Brain Study (VIBeS),
Murdoch Childrens Research Institute
Royal Children's Hospital
50 Flemington Road, Parkville, VIC, 3052, Australia
Country 7830 0
Australia
Phone 7830 0
+61 3 9936 6704
Fax 7830 0
Email 7830 0
peter.anderson@mcri.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary