Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000602426p
Ethics application status
Submitted, not yet approved
Date submitted
1/05/2025
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a consent and relationship education program to improve sexual violence knowledge, attitudes and behaviors among university students living in accommodation: a Non-randomized Controlled Trial
Scientific title
A quasi-experimental, cluster-assigned evaluation of the Consent and Relationship Education (CaRE) program to improve sexual violence knowledge, attitudes, and behaviors among university students living in accommodation at the University of Tasmania, Australia.
Secondary ID [1] 314315 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CaRE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual violence 337267 0
Mental health 337268 0
Condition category
Condition code
Mental Health 333668 333668 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 334041 334041 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical/Informational Materials:

Participants will engage in 2-hour long, facilitator-led, in person educational sessions. The sessions will be delivered by facilitators from the Sexual Assault Support Service (SASS). Facilitators will be sexual violence prevention specialists, with experience delivering primary prevention programs and specific training on the CaRE curriculum provided by SASS. The CaRE program (https://www.sass.org.au/education-and-training/education-in-schools) was originally created by the SASS Primary Prevention team in 2008 as “Consent is a Conversation” and delivered to approximately 18 Tasmanian primary and high schools each year under funding from the Department of Education, Children and Young People: DECYP (previously Department of Education) and a further 7-10 schools as a fee for service program.

In 2023-2024, Consent is a Conversation was updated and renamed “CaRE (Consent and Relationship Education). The CaRE training program was further adapted for University participants in consultation with partners within tertiary education settings. This study will be the first large scale implementation of the adapted CaRE program in a University setting. As such, the materials used to develop CaRE have been developed for this study using existing resources.

Facilitators of the CaRE program will use various materials to deliver the sessions including slides, handouts, and interactive digital tools such as quizzes. Sessions will be delivered in a group format at university residential accommodation venues. Sessions will be interactive, involving both facilitator-led discussions and participant-led group work.

The CaRE intervention broadly covers four topics which are delivered in four individual sessions in this order;

Session 1: rights and responsibilities,
Session 2: power and social norms,
Session 3: pro-social behaviors and
Session 4: practicing consenting conversations.

CaRE will be delivered in two formats. The first format delivered to the treatment arm (CaRE+) will consist of four sessions, as outlined above.

The second format will be delivered to participants in the Exploratory arm. In this format, participants will complete session 1 and session 4 and a third session that participants choose between session 2 and 3.

Participants in the Exploratory arm will self-select between sessions 2 and 3 based on their self-identified gender identity. These 2 sessions have been adapted to reflect the different ways people are socialized according to gender in order to capture how these differences shape both the risk and perpetration of sexual violence. Session 2 has been designed specifically for male-identifying participants, with a focus on challenging harmful norms, while Session 3 has been developed for participants who do not identify as male, centering on assertive communication.

Both formats will be delivered face-to-face in university accommodation settings with each session delivered weekly over three or four weeks depending on the format. The intervention is designed to be implemented in group settings (up to 30 participants per group) and apart from the adaptations in sessions 2 and 3 as described above, the content is not personalized or adapted for individual participants.

At this stage, participants in the standard CaRE group (who received three sessions) will not be offered the additional fourth session after the evaluation period. This decision reflects a combination of practical and resource-related considerations. The program is currently being delivered as part of a time-limited evaluation project, and there are no immediate plans or funding allocated for delivering additional standalone sessions once the evaluation concludes. However, findings from the evaluation will inform how CaRE may be delivered in the future, and we hope that all sessions or tailored versions of them will eventually be available more broadly, depending on institutional uptake and capacity.

Facilitator adherence to the program curriculum will be assessed using fidelity sheets completed after each session. La Trobe University researchers will review the fidelity sheets as well as assess program reach by reviewing aggregated attendance data. Facilitators will also participate in regular debriefs and support sessions offered by SASS to maintain consistency and adherence to program delivery standards.
Intervention code [1] 330927 0
Prevention
Intervention code [2] 330928 0
Behaviour
Comparator / control treatment
The control group in this study will receive standard care during the trial period. Standard care in the University will include online modules on sexual harassment and campus safety offered to all students. Participants in the control arm will not take part in the CaRE (Consent and Relationship Education) program while the intervention arms are running. However, they will be offered the opportunity to participate in the program after all trial data collection has concluded, to ensure equitable access.
Control group
Active

Outcomes
Primary outcome [1] 341268 0
Knowledge related to sexual violence
Timepoint [1] 341268 0
We will assess this outcome at baseline, immediate post intervention, 3 months post and 6 months post intervention.
Secondary outcome [1] 446977 0
Sexual violence victimization
Timepoint [1] 446977 0
We will assess this outcome at baseline, 3-months post and 6-months post intervention
Secondary outcome [2] 446979 0
Attitudes related to sexual violence
Timepoint [2] 446979 0
We will assess this outcome at baseline, immediate post intervention, 3 months and 6 months post intervention.
Secondary outcome [3] 446980 0
Sexual violence perpetration
Timepoint [3] 446980 0
We will assess this outcome at baseline, 3 months and 6 months post intervention.

Eligibility
Key inclusion criteria
The inclusion criteria are:
1) university students living in university accommodation at the University of Tasmania
2) students aged between 18 and 35 years of age.
3) students who consent to participation.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster randomisation will be conducted using a remote, computer-generated system set up by the La Trobe University Statistics Platform.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated by an independent statistician who will have no involvement in program delivery, data collection, or direct contact with any of the residential colleges.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study includes one primary intervention group (Group 1: CaRE+ 4-session), one control group (Group 2: no intervention during the trial period), and an exploratory arm (Group 3: CaRE 3-session). The primary comparison will assess whether the average knowledge scores in the CaRE 4-session group (µ1) are significantly greater than those in the control group (µ2), i.e. H0: d = 0 versus H1: d > 0, where d = µ1 - µ2. The exploratory analysis will assess how the 3-session group (µ3) compares to both the 4-session and control groups.

Based on the most recent meta-analysis of sexual violence prevention programs (Kettrey et al., 2023), we use a conservative standardised mean difference (SMD) of 0.07 for knowledge outcomes. We assume a Type I error rate (a) of 0.025, 80% power, and an intra-cluster correlation (ICC) of 0.026. The coefficient of variation (CV) in cluster size is estimated at 0.71. Sample size estimates were calculated using PASS 2024 (v24.0.1).

Residential colleges are the unit of selection, with nine clusters distributed across four campuses. This design is anticipated to yield a sample of approximately 1,690 students across the residential colleges. With an estimated 20% attrition rate, we expect to retain approximately 1,350 survey responses across all time points. Given the sample size and robust cluster design, the study is sufficiently powered to detect small but meaningful changes in the primary outcome of knowledge.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2025
Actual
Date of last participant enrolment
Anticipated
4/08/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 318837 0
Government body
Name [1] 318837 0
Department of Social Services
Country [1] 318837 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 321300 0
None
Name [1] 321300 0
Address [1] 321300 0
Country [1] 321300 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317454 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 317454 0
Ethics committee country [1] 317454 0
Australia
Date submitted for ethics approval [1] 317454 0
10/04/2025
Approval date [1] 317454 0
Ethics approval number [1] 317454 0

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

Contacts
Principal investigator
Name 141082 0
Prof Leesa Hooker
Address 141082 0
La Trobe University, Edwards Road, Flora Hill, Victoria, 3552
Country 141082 0
Australia
Phone 141082 0
+610354447984
Fax 141082 0
Email 141082 0
[email protected]
Contact person for public queries
Name 141083 0
Innocent Mwatsiya
Address 141083 0
La Trobe University, Plenty Road, Bundoora, Victoria, 3086
Country 141083 0
Australia
Phone 141083 0
+61415390941
Fax 141083 0
Email 141083 0
[email protected]
Contact person for scientific queries
Name 141084 0
Innocent Mwatsiya
Address 141084 0
La Trobe University, Plenty Road, Bundoora, Victoria, 3086
Country 141084 0
Australia
Phone 141084 0
+61415390941
Fax 141084 0
Email 141084 0
[email protected]

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


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.