Trial Review

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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] 310930 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metacognition 331990 0
wellbeing 331991 0
Condition category
Condition code
Mental Health 328732 328732 0 0
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] 327356 0
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] 336541 0
Self Regulated Learning
Timepoint [1] 336541 0
Baseline, 6 weeks post implementation, 6 months post implementation, and 12 months post implementation
Secondary outcome [1] 428741 0
Wellbeing
Timepoint [1] 428741 0
Measured at baseline and 12 months post implementation
Secondary outcome [2] 428742 0
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] 428742 0
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?
No
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)
SA

Funding & Sponsors
Funding source category [1] 315189 0
Government body
Name [1] 315189 0
Department for Education
Country [1] 315189 0
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] 317215 0
None
Name [1] 317215 0
Address [1] 317215 0
Country [1] 317215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314120 0
University of South Australia HREC
Ethics committee address [1] 314120 0
Ethics committee country [1] 314120 0
Australia
Date submitted for ethics approval [1] 314120 0
18/07/2023
Approval date [1] 314120 0
11/09/2023
Ethics approval number [1] 314120 0
205699

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

Contacts
Principal investigator
Name 130478 0
Prof Sally Brinkman
Address 130478 0
University of South Australia, City West Campus, 61-68 North Terrace, Adelaide, South Australia, 5000
Country 130478 0
Australia
Phone 130478 0
+61419814800
Fax 130478 0
Email 130478 0
[email protected]
Contact person for public queries
Name 130479 0
Sally Brinkman
Address 130479 0
University of South Australia, City West Campus, 61-68 North Terrace, Adelaide, South Australia, 5000
Country 130479 0
Australia
Phone 130479 0
+61 419814800
Fax 130479 0
Email 130479 0
[email protected]
Contact person for scientific queries
Name 130480 0
Sally Brinkman
Address 130480 0
University of South Australia, City West Campus, 61-68 North Terrace, Adelaide, South Australia, 5000
Country 130480 0
Australia
Phone 130480 0
+61 419814800
Fax 130480 0
Email 130480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
20862Study protocol    Protocol paper currently under review. Assuming ... [More Details]
20863Ethical approval  [email protected]



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.