Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000858594p
Ethics application status
Submitted, not yet approved
Date submitted
29/05/2024
Date registered
11/07/2024
Date last updated
11/07/2024
Date data sharing statement initially provided
11/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the Teaching Personal and Social Responsibility (TPSR) model on social behaviours of high school students in Physical Education (PE)
Scientific title
The effect of the TPSR model on social behaviours of high school students in PE
Secondary ID [1] 312239 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social behaviours 333946 0
Condition category
Condition code
Public Health 330620 330620 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be on Grade 8 students in NSW Independent Schools. One class from each of the 6 schools will take part. The intervention will consist of regularly scheduled PE classes for all participants. The addition of the TPSR framework will be subtle additions to their communication and interactions incorporating TPSR principles with emphasis on leadership, problem solving and conflict resolution, self awareness and empathy strategies. For example, when playing hockey, when students find themselves disputing who hit the ball out, they will be instructed to resolve conflict through scissors/paper/rock. This will ensure students solve conflicts without adult interference and get back to the game quickly, limiting 'standing around time' and improving engagement.

Teachers will be provided with professional development pre intervention. The TPSR refresher course will provide information on the TPSR framework and how to integrate it into lessons. This will be up to 3 hours, face to face or online. The professional development session will be delivered by the research team.

The intervention will be delivered face to face during students' PE lessons. They will be delivered to 30-33 students, as per NESA student-teacher ratios in NSW.

The students will be involved in 45-60 minute PE lessons weekly, as per NESA requirements in PE.

The intervention will take place in various NSW Independent schools, yet to be confirmed.

Students will be involved with surveys and focus groups for fidelity reasons.

The Stepped wedge approach will be applied to the project whereby schools will take part in the intervention at different times. For example, school A and B will be involved in the intervention in Term 1 2025, then go into post intervention for 2 weeks. School C and D will be involved in the intervention in Term 2 2025 then go into post intervention for 2 weeks, etc.
Intervention code [1] 328690 0
Lifestyle
Comparator / control treatment
When in pre-post intervention students will be involved in their regularly scheduled PE lessons or completing surveys/ focus groups.
Control group
Active

Outcomes
Primary outcome [1] 338364 0
Social behaviours like leadership, conflict resolution, problem solving, efficacy.
This is a composite primary outcome.
Timepoint [1] 338364 0
At the post test phase 2 weeks after the intervention has concluded.
Secondary outcome [1] 436716 0
Behaviour
Timepoint [1] 436716 0
Post intervention- 2-4 weeks after the intervention concludes. One time interview will take place.

Eligibility
Key inclusion criteria
Students are included in the study if they are 13-14 years old, physically and mentally fit, speak English, have consent, enrolled in participating Independent schools in NSW, are participating face to face.
Minimum age
13 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation- schools volunteer to be a part of the study and principals allocate the classes. Gender and age will be factors in the stratification process.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316617 0
University
Name [1] 316617 0
University of Sydney
Country [1] 316617 0
Australia
Primary sponsor type
Individual
Name
Sonja Maric, University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318803 0
Individual
Name [1] 318803 0
Wayne Cotton, University of Sydney
Address [1] 318803 0
Country [1] 318803 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315402 0
The University of Sydney HREC 2
Ethics committee address [1] 315402 0
Ethics committee country [1] 315402 0
Australia
Date submitted for ethics approval [1] 315402 0
22/05/2024
Approval date [1] 315402 0
Ethics approval number [1] 315402 0

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

Contacts
Principal investigator
Name 134590 0
Dr Wayne Cotton
Address 134590 0
University of Sydney, Camperdown NSW 2050
Country 134590 0
Australia
Phone 134590 0
+61 439408036
Fax 134590 0
Email 134590 0
wayne.cotton@sydney.edu.au
Contact person for public queries
Name 134591 0
Sonja Maric
Address 134591 0
University of Sydney, Camperdown NSW 2050
Country 134591 0
Australia
Phone 134591 0
+61 421459309
Fax 134591 0
Email 134591 0
sonja.maric@mq.edu.au
Contact person for scientific queries
Name 134592 0
Sonja Maric
Address 134592 0
University of Sydney, Camperdown NSW 2050
Country 134592 0
Australia
Phone 134592 0
+61 421459309
Fax 134592 0
Email 134592 0
sonja.maric@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.