ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623001331628

Ethics application status

Approved

Date submitted

9/11/2023

Date registered

19/12/2023

Date last updated

19/12/2023

Date data sharing statement initially provided

19/12/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluating the impact of a self regulated learning program in primary schools

Scientific title

Pragmatic clustered randomised control trial to evaluate a self-regulated learning intervention to be implemented in South Australian primary school students.

Secondary ID [1]

Nill

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

metacognition

wellbeing

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention consists of a set of lessons introducing the process of Mental Contrasting with Implementation Intentions (MCII). MCII is a self-regulation technique that combines cognitive strategies to help individuals achieve their goals. The intervention will be implemented by teachers over 5 hours (1 hour per week). As a pragmatic trial, adherence will be monitored by teacher report post intervention (i.e. did they achieve the 5 hours within the 5 weeks) and student attendance records will provide exposure at the student level.

Intervention code [1]

Behaviour

Comparator / control treatment

Control group will be exposed to their normal school program (standard care). This would entail students attending classes just as normal and teachers delivering their classes as normal.

Control group

Active

Outcomes

Primary outcome [1]

Self Regulated Learning

Timepoint [1]

Baseline, 6 weeks post implementation, 6 months post implementation, and 12 months post implementation

Secondary outcome [1]

Wellbeing

Timepoint [1]

Measured at baseline and 12 months post implementation

Secondary outcome [2]

Academic outcome will be as assessed by the student meeting the national minimum proficiency standard (or not) on the Australian National Assessment Program in Literacy and Numeracy (NAPLAN) test.

Timepoint [2]

Undertaken in years 3, 5, and 7 (so 12 months post intervention for year 2, 4 and 6 students).

Eligibility

Key inclusion criteria

Schools that have at least 15 students within one class in grade 2, grade 4, and grade 6 will be included. Those South Australian Government Primary Schools who meet these criteria, will be invited to participate by the Department for Education. The intervention will be delivered in grades 2, 4, and 6. All students within the selected classes will participate in the study.

Minimum age

6 Years

Maximum age

14 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

There will be no exclusion to the trial at class or individual child level.

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)

Allocation will be concealed. Department for Education staff will be recruiting schools prior to allocation. After recruitment, allocation will be conducted by University staff blinded to school name utilising a project specific school ID provided by the Department. The allocation will then be provided back to the Department who will then match the project ID back to school name. The Department will then inform the already recruited schools of their allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Schools will be the level of randomisation and class the level of implementation. Randomisation will be stratified by socio-economic status blocks (using the Socio-Economic Indexes for Areas - SEIFA indicator) and metropolitan vs. non-metropolitan area. The advantage of numerous classes within the one school grade level has limited advantage for sample power due to the design effect associated with clustering. As such, at least one class per eligible grade level will be randomly selected for the intervention. Teachers will implement the intervention at the class level. The trial will be powered to assess the impact of the SRL intervention on three grades independently: Grade 2 (early primary), Grade 4 (mid primary), and Grade 6 (late primary). The intervention will be implemented in literacy/reading lessons. Class lists will be provided by each of the participating schools for the process of randomisation. Note that schools in the treatment group may decide to implement the SRL intervention in more than one class within the school, however only selected classes will be enlisted for the study

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

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

The primary analysis will use the intent-to-treat principle. Baseline balance will be checked between trial arms to see whether randomisation was successful. Estimation of treatment effects will be obtained from a generalised linear mixed model (GLMM) to produce the mean difference in scores for SRL intervention versus control. The GLMM will include a random effect for cluster, and a random effect for the child taking account of the repeated measure design, a fixed effect for time, and use an exchangeable correlation structure of the appropriate variance-covariance matrix. The same analytical approach will be applied for secondary outcomes of interest. Longitudinal data collected for school cohort participants will be linked using student Education IDs. Student household characteristics may serve as predictors of interest in adjusted analyses.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2024

Actual

Date of last participant enrolment

Anticipated

1/04/2024

Actual

Date of last data collection

Anticipated

31/08/2026

Actual

Sample size

Target

3192

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department for Education

Address [1]

31 Flinders Street, Adelaide, South Australia, 5000

Country [1]

Australia

Primary sponsor type

University

Name

University of South Australia

Address

City West Campus, 61-68 North Terrace, Adelaide, 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia HREC

Ethics committee address [1]

University of South Australia, 61-68 North Terrace, Adelaide, South Australia, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/07/2023

Approval date [1]

11/09/2023

Ethics approval number [1]

205699

Summary

Brief summary

Self-Regulated Learning (SRL) is described as a process whereby learners actively take control of their learning by setting goals, planning, monitoring, evaluating, and adjusting their learning strategies to improve performance and achieve desired outcomes. SRL proficiency has been shown to predict educational success and lifelong outcomes, such as income and health. While SRL is recognized as a key lifelong competency, there remain questions regarding how educators can best develop and promote SRL in school settings. A scalable, low-cost intervention targeted at grade 1 students (6-7 years old) in Germany was found to have substantial effects on impulse control and self-regulated learning, with sustained impacts on long term academic success. This study seeks to adapt the Schunk et al (2022) randomised trial to the Australian content and extend it to grades levels 2, 4 and 6

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sally Brinkman

Address

University of South Australia, City West Campus, 61-68 North Terrace, Adelaide, South Australia, 5000

Country

Australia

Phone

+61419814800

Fax

sally.brinkman@unisa.edu.au

Contact person for public queries

Name

Sally Brinkman

Address

University of South Australia, City West Campus, 61-68 North Terrace, Adelaide, South Australia, 5000

Country

Australia

Phone

+61 419814800

Fax

sally.brinkman@unisa.edu.au

Contact person for scientific queries

Name

Sally Brinkman

Address

University of South Australia, City West Campus, 61-68 North Terrace, Adelaide, South Australia, 5000

Country

Australia

Phone

+61 419814800

Fax

sally.brinkman@unisa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Not currently. This will depend on the Department for Education's agreement as the custodian of student level data.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
20862	Study protocol				Protocol paper currently under review. Assuming ... [More Details]
20863	Ethical approval			sally.brinkman@unisa.edu.au

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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