Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000486022
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
11/06/2010
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing early academic problems by improving working memory in young children: Translational randomised trial
Scientific title
For children with low working memory, does a computer-based training intervention, compared with standard classroom teaching, result in improved academic and working memory function?
Secondary ID [1] 251816 0
none
Universal Trial Number (UTN)
U1111-1115-0568
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Learning difficulty 257412 0
Low working memory 257413 0
Condition category
Condition code
Public Health 257560 257560 0 0
Health promotion/education
Mental Health 257561 257561 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A brief computerised intervention aimed at improving children’s working memory called Robomemo, manufactured by Cogmed.

The program trains working memory skills using an interactive and motivating, game-format, computerised training program. It runs for 35 minutes a day for 20 sessions over 5-7 weeks. All training is conducted at school in small groups of 4 to 8 students under supervision. Eight tasks are completed every day. The children train on the same tasks for the first 5 days. A new task replaces one of the existing tasks on day 6 and every 5th day after this. Within each task, the adaptive nature of the program matches difficulty to the child’s current working memory skill on a day-by-day basis, with all tasks increasing in complexity according to the child’s current skill.

The intervention children will also receive information regarding classroom strategies (as will the control group- see below).
Intervention code [1] 256515 0
Treatment: Other
Intervention code [2] 256650 0
Prevention
Intervention code [3] 256651 0
Early detection / Screening
Comparator / control treatment
Students randomised to the control group will receive information regarding strategies to prevent working memory overload in the classroom. This is the current standard care for children with working memory difficulties.
Control group
Active

Outcomes
Primary outcome [1] 258475 0
Primary outcome: academic outcomes using the Wide Range Achievement Test (WRAT 4). This valid and reliable tool yields standard (mean 100, standard deviation (SD) 15) reading composite (word reading and sentence comprehension subtests) and maths computation scores. The WRAT will determine if early working memory benefits translate into subsequent learning.
Timepoint [1] 258475 0
12 and 24 months post intervention
Secondary outcome [1] 264267 0
Working memory using the Automated Working Memory Assessment (AWMA). Standardised for ages 4-22 years, the AWMA is a computer-based, valid and reliable working memory assessment tool that yields composite and subtest scores (mean 100, SD 15). We will administer the following subtests: digit recall, listening recall, dot matrix, spatial span and backward digit recall (assessing verbal, visuo-spatial and central executive components of working memory). This will show whether short-term working memory gains are made and sustained over time.
Timepoint [1] 264267 0
6 and 12 months post intervention

Eligibility
Key inclusion criteria
Children with working memory difficulties in grade 1: this is defined as children scoring below the 20th percentile on both a verbal and visuo-spatial working memory screening task from the AWMA.
Minimum age
6 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Problems judged by the school or Chief Investigator (CI) Roberts (a developmental-behavioural paediatrician) as severe enough to prevent participation in the assessment and/or intervention, eg cerebral palsy, vision/hearing impairments or pervasive developmental disorders.

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)
All state primary schools in a single metropolitan Melbourne school district will be eligible following approval from the Reasearch in School department of the Department of Education and Early Childhood Development (DEECD). We will first approach each school’s principal for their agreement to take part; if a school declines (10-25% of schools in our previous studies), we will go to the next randomly-selected school on the back-up list, until we reach the required sample size of 2900 children for initial screening for eligibility.

Children’s allocation will be revealed to the research team via a web-based randomisation management system, which ensures allocation concealment until eligibility and consent have been confirmed. The randomisation schedule will be produced independently by the Clinical Epidemiology and Biostatistics Unit at the Murdoch Childrens Research Institute.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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
1/02/2012
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
9/08/2012
Date of last data collection
Anticipated
Actual
31/12/2014
Sample size
Target
375
Accrual to date
Final
452
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2900 0
3190

Funding & Sponsors
Funding source category [1] 257002 0
Government body
Name [1] 257002 0
Application under consideration by the National Health and Medical Research Council
Country [1] 257002 0
Australia
Primary sponsor type
Hospital
Name
Royal Childrens Hospital, Melbourne
Address
Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 256264 0
Charities/Societies/Foundations
Name [1] 256264 0
Murdoch Childrens Research Institute
Address [1] 256264 0
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country [1] 256264 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259022 0
Ethics and Research Committee, Royal Children's Hospital, Melbourne
Ethics committee address [1] 259022 0
Ethics committee country [1] 259022 0
Australia
Date submitted for ethics approval [1] 259022 0
28/05/2010
Approval date [1] 259022 0
29/09/2010
Ethics approval number [1] 259022 0
30104

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

Contacts
Principal investigator
Name 31188 0
A/Prof A/Prof Gehan Roberts
Address 31188 0
Centre for Community Child Health Royal Children's Hospital Flemington Rd. Parkville VIC 3052
Country 31188 0
Australia
Phone 31188 0
61 3 9345 5356
Fax 31188 0
Email 31188 0
[email protected]
Contact person for public queries
Name 14435 0
A/Prof Gehan Roberts
Address 14435 0
Centre for Community Child Health
Royal Children's Hospital
Flemington Rd.
Parkville
VIC 3052
Country 14435 0
Australia
Phone 14435 0
61 3 9345 5356
Fax 14435 0
61 3 9345 5900
Email 14435 0
[email protected]
Contact person for scientific queries
Name 5363 0
A/Prof Gehan Roberts
Address 5363 0
Centre for Community Child Health
Royal Children's Hospital
Flemington Rd.
Parkville
VIC 3052
Country 5363 0
Australia
Phone 5363 0
61 3 9345 5356
Fax 5363 0
61 3 9345 5900
Email 5363 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseCan working memory training improve children's sleep?.2018https://dx.doi.org/10.1016/j.sleep.2017.11.1143
EmbaseInfluence of Gestational Age and Working Memory on Math Skills in Children Aged 8 to 9 Years.2019https://dx.doi.org/10.1097/DBP.0000000000000614
EmbaseThe Effectiveness of Working Memory Training for Children With Low Working Memory.2020https://dx.doi.org/10.1542/peds.2019-4028
N.B. These documents automatically identified may not have been verified by the study sponsor.