ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

U1111-1115-0568

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Learning difficulty

Low working memory

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

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]

Treatment: Other

Intervention code [2]

Prevention

Intervention code [3]

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]

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]

12 and 24 months post intervention

Secondary outcome [1]

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]

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]

3190

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Application under consideration by the National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Childrens Hospital, Melbourne

Address

Flemington Rd
Parkville VIC 3052

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Murdoch Childrens Research Institute

Address [1]

Royal Children's Hospital
Flemington Rd
Parkville VIC 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics and Research Committee, Royal Children's Hospital, Melbourne

Ethics committee address [1]

Flemington Rd
Parkville, VIC, 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/05/2010

Approval date [1]

29/09/2010

Ethics approval number [1]

30104

Summary

Brief summary

Learning difficulties are common and can cause school failure and poor self-esteem. They are associated with specific problems with temporarily remembering and using information (‘working memory’). Research suggests that improving working memory might improve academic achievement. We will study this intervention in a large group of primary school children who have poor working memory. If successful, the intervention will provide a way to improve the learning skills of these high-risk children.

Trial website

http://www.rch.org.au/ccch/for_researchers/Memory_Maestros_Study/

Trial related presentations / publications

Roberts G, Quach J, Spencer-Smith M, et al. Academic Outcomes 2 Years After Working Memory Training for Children With Low Working Memory: A Randomized Clinical Trial. JAMA Pediatr. 2016;170(5):e154568. doi:10.1001/jamapediatrics.2015.4568

Public notes

Contacts

Principal investigator

Name

A/Prof A/Prof Gehan Roberts

Address

Centre for Community Child Health Royal Children's Hospital Flemington Rd. Parkville VIC 3052

Country

Australia

Phone

61 3 9345 5356

Fax

gehan.roberts@rch.org.au

Contact person for public queries

Name

A/Prof Gehan Roberts

Address

Centre for Community Child Health
Royal Children's Hospital
Flemington Rd.
Parkville
VIC 3052

Country

Australia

Phone

61 3 9345 5356

Fax

61 3 9345 5900

gehan.roberts@rch.org.au

Contact person for scientific queries

Name

A/Prof Gehan Roberts

Address

Centre for Community Child Health
Royal Children's Hospital
Flemington Rd.
Parkville
VIC 3052

Country

Australia

Phone

61 3 9345 5356

Fax

61 3 9345 5900

gehan.roberts@rch.org.au

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

Source	Title	Year of Publication	DOI
Embase	Can working memory training improve children's sleep?.	2018	https://dx.doi.org/10.1016/j.sleep.2017.11.1143
Embase	Influence of Gestational Age and Working Memory on Math Skills in Children Aged 8 to 9 Years.	2019	https://dx.doi.org/10.1097/DBP.0000000000000614
Embase	The Effectiveness of Working Memory Training for Children With Low Working Memory.	2020	https://dx.doi.org/10.1542/peds.2019-4028

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically