Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000402549
Ethics application status
Approved
Date submitted
15/03/2024
Date registered
3/04/2024
Date last updated
23/07/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Breaking Barriers: Transforming Teen Behaviours with Kai Fella Workshops
Scientific title
An interventional study of the impact of the Kai Fella 'Challenging Stereotypes' workshops on transforming behaviours in young adolescent males.
Secondary ID [1] 311729 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Help-seeking behaviours 333212 0
Condition category
Condition code
Mental Health 329900 329900 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Schools partaking in a Kai Fella 'Challenging Stereotypes' workshop will be approached to take part in this study. After obtaining informed consent from schools and parents, and informed assent from the young boys participating in the workshops, boys will complete a series of surveys before and after participating the workshop. The workshop itself discusses themes of masculine stereotypes, men's mental health and suicide statistics, and strategies to improve conversation between peers on the topic of mental health. The workshops are organised and run independently from the research team and this study is purely analysing the behaviours and perceptions of boys before and after taking part in this workshop.
The workshops are designed as an interactive learning and peer-discussion session in which students are asked to share and practice in the learning material. Each student attends only one (1) Challenging Workshop workshop that runs for a maximum of 2-hours. A class roll will be obtained by teachers overseeing the session and will allow the research team to monitor the attendance of those students eligible for participation in the questionnaires.
Intervention code [1] 328190 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337664 0
Help-seeking behaviours - assessed as a composite outcome.
Timepoint [1] 337664 0
Baseline, 1 week post-intervention (primary endpoint), 3 month follow up
Primary outcome [2] 337665 0
Conformity to Masculine Norms - This is an additional primary outcome.
Timepoint [2] 337665 0
Baseline, 1 week post-intervention (primary endpoint), 3 month follow up
Primary outcome [3] 337666 0
Perceived Social Support - This is an additional primary outcome.
Timepoint [3] 337666 0
Baseline, 1 week post-intervention (primary endpoint), 3 month follow up
Secondary outcome [1] 432749 0
Comfort in Difficult Conversations
Timepoint [1] 432749 0
Baseline, 1 week post-intervention, 3 month follow up
Secondary outcome [2] 432750 0
Workshop Satisfaction
Timepoint [2] 432750 0
1-week post-intervention

Eligibility
Key inclusion criteria
School Inclusion Criteria:
1. Partaking in a Kai Fella "Challenging Stereotypes' workshops for their years 10, 11, or 12 male students in 2024 and 2025.
2. Agree to distribute study information to parents of young males enrolled in the workshops, and to allocate three class times for students to complete the baseline, post-intervention, and follow-up surveys.

Student Inclusion Criteria:
1. Student is enrolled in either year 10, 11, or 12 in a participating school of a Kai Fella "Challenging Stereotypes" workshop.
2. Student self-identifies as male.
3. Student is enrolled to take part in a Kai Fella "Challenging Stereotypes" workshop.

Teacher Inclusion Criteria:
1. Enrolled to observe and supervise students taking part in a Kai Fella "Challenging Stereotypes" workshop.
Minimum age
14 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
ANOVA and subsequent t-tests will determine changes to mean questionnaire scores across the three questionnaires. Differences between sub-groups such as school type, region, and social economic status may be analysed. No interim analyses will be conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
17/04/2024
Date of last participant enrolment
Anticipated
4/07/2025
Actual
Date of last data collection
Anticipated
4/10/2025
Actual
Sample size
Target
545
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316060 0
Government body
Name [1] 316060 0
Australian Government Department of Education Research Training Program
Country [1] 316060 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Perron Institute for Neurological and Translational Science
Address
Country
Australia
Secondary sponsor category [1] 318223 0
University
Name [1] 318223 0
The University of Western Australia
Address [1] 318223 0
Country [1] 318223 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314879 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 314879 0
Ethics committee country [1] 314879 0
Australia
Date submitted for ethics approval [1] 314879 0
29/02/2024
Approval date [1] 314879 0
06/03/2024
Ethics approval number [1] 314879 0
2023/ET000993

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

Contacts
Principal investigator
Name 133034 0
A/Prof Jennifer Rodger
Address 133034 0
Perron Institute for Neurological and Translational Science, Level 1 RR Block QE II Medical Centre Ralph & Patricia Sarich Neuroscience Building, 8 Verdun St, Nedlands WA 6009
Country 133034 0
Australia
Phone 133034 0
+61 459261957
Fax 133034 0
Email 133034 0
[email protected]
Contact person for public queries
Name 133035 0
Bradley Roberts
Address 133035 0
Perron Institute for Neurological and Translational Science, Level 1 RR Block QE II Medical Centre Ralph & Patricia Sarich Neuroscience Building, 8 Verdun St, Nedlands WA 6009
Country 133035 0
Australia
Phone 133035 0
+61 401179395
Fax 133035 0
Email 133035 0
[email protected]
Contact person for scientific queries
Name 133036 0
Bradley Roberts
Address 133036 0
Perron Institute for Neurological and Translational Science, Level 1 RR Block QE II Medical Centre Ralph & Patricia Sarich Neuroscience Building, 8 Verdun St, Nedlands WA 6009
Country 133036 0
Australia
Phone 133036 0
+61 401179395
Fax 133036 0
Email 133036 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


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.