Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000409471p
Ethics application status
Submitted, not yet approved
Date submitted
4/04/2025
Date registered
6/05/2025
Date last updated
6/05/2025
Date data sharing statement initially provided
6/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Schools Education Program: a cluster-randomised controlled trial investigating the efficacy of a sexual violence primary prevention program in Australian secondary schools
Scientific title
A parallel, two-arm cluster randomised controlled study of Year 9 students at 12 Australian secondary schools to evaluate the effectiveness of a sexual violence primary prevention program on students’ knowledge, attitudes and behavioural intentions.
Secondary ID [1] 314121 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual violence 336937 0
Condition category
Condition code
Public Health 333405 333405 0 0
Health promotion/education
Mental Health 333520 333520 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Schools Education Program (SEP) educational intervention aims to educate students on healthy sexual relationships and prevent sexual violence by enhancing student knowledge, attitudes and behavioural intentions.

Year 9 students in the intervention arm will receive three in-person 90-minute sessions of SEP across a seven-week period. The sessions will be delivered by trained facilitators from Laurel House, in partnership with the Tasmanian Women’s Legal Service. The sessions will be delivered during class time with two-week intervals between sessions.

Session One:
In the first session, facilitators will use small-group activities and open discussion to explore the following topics: 1) healthy relationships, including communication, boundaries, mutual respect and consent, 2) defining sexual violence, common misconceptions about sexual violence, and recognising its impact on victim-survivors, 3) gender equality and harmful stereotypes, law changes over time that have affected women’s roles, gendered societal expectations, and how these influence perceptions of sexual violence.

Session Two:
This session delves into legal aspects of consent and emerging forms of sexual violence. With expert insights from a women’s legal service lawyer, the session will explore: 1) legal definitions of consent, 2) image-based abuse, 3) non-fatal strangulation (sexual choking), stealthing and the law, 4) and guidance on accessing legal support and counselling.

Session Three:
The final session for students will focus on navigating consent, digital safety, and active bystander strategies. Using discussion and small-group scenarios, facilitators will focus on 1) building skills for clear, respectful dialogue about boundaries and mutual agreement in relationships, 2) how pornography shapes perceptions of sex, relationships, and unrealistic expectations. 3) reinforcing the serious legal consequences of accessing, sharing, or producing Child Sexual Abuse Material, and its lifelong harms to victim-survivors. 4) early warning signs and strategies to address harmful sexual behaviours, and 5) practical bystander strategies to safely challenge harmful behaviours, support potential victims, and disrupt unsafe situations.

In addition to educational sessions, there will be ‘School Student Champions’ (SSC) recruited at each school to help accelerate the diffusion of messages in the school population. Key points about the SSCs:
- Expressions of interest will be invited from students at each school to become SSCs – up to 7 SSCs per school
- Laurel House will consult with SSCs regarding any specific issues or concerns at the school
-SSCs will be given leaflets and posters of support services to display in areas of the school
-Laurel House will check-in with SSCs between sessions to gain feedback and a sense of how the sessions have been received.

Additionally, members of the school staff and parents/caregivers will be invited to attend a 2-hour educational session on consent and healthy relationships prior to the commencement of the student sessions.

The SEP intervention includes the use of available resources such as The Consent Continuum (Body Safety Australia), the Healthy Relationship Wheel (Reproductive Health National Training Center), Duluth Equality Wheel (Domestic Abuse Intervention Project), Commonwealth Consent Policy Framework (Department of Social Services), and resources adapted from The Line (Our Watch), eSafety Commissioner (Australian Government), and the It’s Time We Talked program designed by Maree Crabbe and David Corlett. Other resources and activities have been developed for SEP by Laurel House, including scenario cards, and a range of interactive, small-group activities focused on gender stereotypes, timeline of laws, identifying trusted people, and communication skills.

Adherence to the intervention will be assessed using fidelity sheets completed by facilitators delivering the sessions.

Year 9 students in the control arm will not receive the program and will instead receive their usual school curriculum.
Intervention code [1] 330717 0
Prevention
Intervention code [2] 330812 0
Behaviour
Comparator / control treatment
Control comparator – Waitlist of Secondary School students (receiving usual school curriculum) with no receipt of a sexual violence primary prevention program. The control group will be offered the intervention after the intervention period has concluded, in 2026.
Control group
Active

Outcomes
Primary outcome [1] 340983 0
Knowledge about sexual violence including gender equality, consent, healthy relationships, and rape myths (composite primary outcome)
Timepoint [1] 340983 0
Baseline, immediate-post and 6-month follow-up
Secondary outcome [1] 445673 0
Attitudes toward gender equality, rape myths, and empathy (composite secondary outcome)
Timepoint [1] 445673 0
Baseline, immediate-post, 6-month follow-up
Secondary outcome [2] 445674 0
Behavioural intentions associated with consent and bystander intervention (composite secondary outcome)
Timepoint [2] 445674 0
Baseline, immediate-post, 6-month follow-up

Eligibility
Key inclusion criteria
1) students attending public secondary schools in Northern Tasmania, Australia
2) students in Year 9-aged 13-15 in these schools who consent to participate in the study and
3) whose parents or caregivers of students in these schools' consent to their participation.
Minimum age
13 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) students attending private schools
2) students who do not consent to participate, and
3) students whose parents do not consent to their participation
4) students outside Year 9.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools (clusters) will be randomised using a remote system set up by the LTU Statistics Platform. The allocation sequence will be stored on a secure server and concealed from all personnel involved in the trial. It will be created, using computer-generated random numbers, by a statistician with no link to, or contact with, any of the participating schools.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using computer-generated random numbers, randomisation will be stratified by the following five variables:
1) Year 9 student population (size)
2) Region of Tasmania
3) Index of Relative Socio-Economic Disadvantage, by suburb and locality (IRSD)
4) Indigenous enrolment, percentage
5) Index of Community, Socio-Educational Advantage (ICSEA)
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 study results will be reported using the CONSORT guidelines for cluster RCTs. The proportion of students completing baseline, immediate-post and six-month follow-up surveys will be reported. A descriptive analysis will be used to summarise and describe the baseline characteristics (categorical or continuous variables) of the student participants, such as age, gender, sexual orientation, Indigeneity, country of birth, language spoken at home, and autism, ADHD or learning disabilities. For the quantitative outcome measures, a comparison of the intervention and control will be undertaken using SPSS or STATA to determine whether the Group 1 (treatment) mean (µ1) is greater than the Group 2 (control) mean (µ2) (H0: d = 0 versus H1: d > 0, d = µ1 - µ2) on the primary outcome of knowledge. This will be repeated for secondary outcomes e.g. attitudes and behavioural intentions. Mean differences on outcomes will be assessed across trial arm and between baseline and post, baseline and follow up and post and follow up. The comparison will be made using a one-sided t-test (alpha 0.025) with the degrees of freedom based on the total number of subjects. Estimates for differences between intervention and control (odds ratios and least squares mean differences) will be adjusted for clustering (students nested within schools) and presented alongside 95% CIs. Intention to treat analysis will be completed and any missing data will be reported and managed using listwise deletion.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 318630 0
Government body
Name [1] 318630 0
Department of Social Services
Country [1] 318630 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 321056 0
None
Name [1] 321056 0
Address [1] 321056 0
Country [1] 321056 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317235 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 317235 0
Ethics committee country [1] 317235 0
Australia
Date submitted for ethics approval [1] 317235 0
10/01/2025
Approval date [1] 317235 0
Ethics approval number [1] 317235 0
Ethics committee name [2] 317248 0
Research Application Advisory Committee, Department for Education, Children and Young People, Tasmania
Ethics committee address [2] 317248 0
Ethics committee country [2] 317248 0
Australia
Date submitted for ethics approval [2] 317248 0
20/02/2025
Approval date [2] 317248 0
Ethics approval number [2] 317248 0
2025 -06

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

Contacts
Principal investigator
Name 140426 0
Prof Leesa Hooker
Address 140426 0
La Trobe University, Edwards Road, Flora Hill, Victoria 3552
Country 140426 0
Australia
Phone 140426 0
+613 5444 7984
Fax 140426 0
Email 140426 0
[email protected]
Contact person for public queries
Name 140427 0
Vivienne Moyle
Address 140427 0
Level 2, David Myers Building (East), La Trobe University, Plenty Road, Bundoora, Victoria 3086
Country 140427 0
Australia
Phone 140427 0
+613 9479 1443
Fax 140427 0
Email 140427 0
[email protected]
Contact person for scientific queries
Name 140428 0
Leesa Hooker
Address 140428 0
La Trobe University, Edwards Road, Flora Hill, Victoria 3552
Country 140428 0
Australia
Phone 140428 0
+613 5444 7984
Fax 140428 0
Email 140428 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24596Study protocol  [email protected]
24597Ethical 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.