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Trial registered on ANZCTR


Registration number
ACTRN12616001612404
Ethics application status
Approved
Date submitted
17/11/2016
Date registered
22/11/2016
Date last updated
17/09/2020
Date data sharing statement initially provided
17/09/2020
Date results provided
17/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of the QuickSmart Numeracy program on the mathematics outcomes of year 4 and 8 students.
Scientific title
QuickSmart Numeracy: A randomized control trial investigating the efficacy of the 30 week QuickSmart numeracy program on Progressive Achievement Test (Mathematics) results among year 4 and 8 students demonstrating low numeracy abilities.
Secondary ID [1] 290566 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Numeracy ability 301015 0
Mathematics efficacy 301016 0
Condition category
Condition code
Other 300811 300811 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants (school students in year 4 and 8) are asked to undertake additional mathematics tuition (3 x 30 minute sessions / week within school hours) across 3 school terms (30 weeks). QuickSmart tuition is focused on improving the speed and accuracy of basic arithmetic computation. Sessions are undertaken by teacher's aids who have undertaken the QuickSmart instructor training (3 day workshop). Sessions are undertaken with two students at a time, with the CAAS system (see below) recording session attendance and progress.

QuickSmart tuition involves:
1- Flash cards and number recall games using numerical operations: number naming, addition number facts, subtraction number facts, multiplication number facts, division number facts, and triple addition tasks (for example, 7 + 4 + 3).
2- Cognitive Aptitude Assessment System (CAAS)
The CAAS system provides measures of how rapidly students complete tasks by speaking into a microphone once a number fact is displayed on the computer screen. An instructor scores each response for accuracy.
3- Students graphing of CAAS results.
Intervention code [1] 296434 0
Treatment: Other
Comparator / control treatment
The control group undertake standard mathematics tuition offered during their schools regular programming.
Control group
Active

Outcomes
Primary outcome [1] 300233 0
Progressive Achievement Test - Mathematics (PAT-M)
Timepoint [1] 300233 0
March 2018 - 16 months post commencement of the 30 week intervention.
Secondary outcome [1] 329439 0
This composite measure includes: i) student self-efficacy, and ii) engagement in mathematics (Programme for International Student Assessment scales).
Timepoint [1] 329439 0
March 2018 - 16 months post commencement of the 30 week intervention.

Eligibility
Key inclusion criteria
1- Participants are in Year 4 or 8 in 2017
2- Bottom 30% nationally in the most recent National Assessment Programme - Literacy and Numeracy (NAPLAN) - Numeracy outcome.
Minimum age
7 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1- NAPLAN - numeracy above bottom 30% nationally
2- Previous participation in QuickSmart Numeracy
3- Not in year 4 or 8 in 2017

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by independent third party via a coin toss after baseline assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss allocation of matched pairs
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be completed using PASW Statistics 21 (SPSS Inc. Chicago, IL) software. Alpha levels are set at p < 0.05. Independent samples t-tests will be used to compare differences between groups at baseline. Linear mixed models will be fitted to compare intervention and control groups for continuous variables. Group (intervention or control), time (baseline and follow-up) and group-by-time interaction will be assessed as fixed effects within the model. Potential gender effects will be explored using a group-by-time-by-gender interaction term in the mixed model. Differences of means and 95% confidence intervals (CIs) are determined using the linear mixed models. Analyses include all randomized participants. Hedges g is used to determine effect sizes of the change in mean for each group relative to the baseline value (effect of intervention on the change score).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/12/2016
Actual
23/01/2017
Date of last participant enrolment
Anticipated
28/02/2017
Actual
10/03/2017
Date of last data collection
Anticipated
11/07/2018
Actual
11/07/2018
Sample size
Target
315
Accrual to date
Final
313
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295003 0
Charities/Societies/Foundations
Name [1] 295003 0
Social Ventures Australia - Evidence for Learning Fund
Country [1] 295003 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 293821 0
University
Name [1] 293821 0
University of New ENgland
Address [1] 293821 0
Armidale, NSW, 2351
Country [1] 293821 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296356 0
University of Newcastle - Human Research Ethics Committee
Ethics committee address [1] 296356 0
Ethics committee country [1] 296356 0
Australia
Date submitted for ethics approval [1] 296356 0
15/09/2016
Approval date [1] 296356 0
09/11/2016
Ethics approval number [1] 296356 0
H-2016-0338

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

Contacts
Principal investigator
Name 70570 0
Dr Andrew Miller
Address 70570 0
University of Newcastle
EN2.05, Chittaway Rd, OURIMBAH, NSW, 2258
Country 70570 0
Australia
Phone 70570 0
+61 2 434 84214
Fax 70570 0
Email 70570 0
andrew.miller@newcastle.edu.au
Contact person for public queries
Name 70571 0
Andrew Miller
Address 70571 0
University of Newcastle
EN2.05, Chittaway Rd, OURIMBAH, NSW, 2258
Country 70571 0
Australia
Phone 70571 0
+61 2 434 84214
Fax 70571 0
Email 70571 0
andrew.miller@newcastle.edu.au
Contact person for scientific queries
Name 70572 0
Andrew Miller
Address 70572 0
University of Newcastle
EN2.05, Chittaway Rd, OURIMBAH, NSW, 2258
Country 70572 0
Australia
Phone 70572 0
+61 2 434 84214
Fax 70572 0
Email 70572 0
andrew.miller@newcastle.edu.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
No additional documents have been identified.