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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
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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.
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Secondary ID [1]
314315
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
CaRE trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sexual violence
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Mental health
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Condition category
Condition code
Mental Health
333668
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0
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Studies of normal psychology, cognitive function and behaviour
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Mental Health
334041
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330927
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Prevention
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Intervention code [2]
330928
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Knowledge related to sexual violence
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Assessment method [1]
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To assess changes in knowledge, we will use the Recognise Violence Against Women scale; a validated subscale of the Understanding Violence Against Women scale in the National Community Attitudes towards Violence Against Women Survey (NCAS) (Coumarelos et al., 2023). The NCAS is a nationally representative survey conducted in Australia to measure changes in knowledge, attitudes, and beliefs about violence against women. We prefer to use this NCAS tool as it has been used and validated in Australia. The Recognise Violence Against Women measures respondents’ knowledge of violence against women using four questions on a 5-point Likert scale. Some of the questions include items such as "do you consider abusive messages or comments targeted at women on social media to be a form of violence against women". Whilst this scale does not ask respondents directly about their knowledge related to sexual violence, it allows us to capture outcomes that are linked to some of the drivers of violence against women and sexual violence (Our Watch, 2021). By capturing changes in these forms of knowledge, we will be able to capture changes in knowledge items that are linked to drivers of sexual violence.
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Timepoint [1]
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We will assess this outcome at baseline, immediate post intervention, 3 months post and 6 months post intervention.
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Secondary outcome [1]
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Sexual violence victimization
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Assessment method [1]
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We will measure victimization using the Contact module of the Revised Sexual Experiences Survey Victimization Version (SES-V) developed by Koss et al., (2024). The Contact module measures experiences of specific unwanted sexual behaviours involving physical contact. It has 11 items where the response options within each item are a = non-penetrative sexual contact, option b = oral penetration, option c = vaginal/genital opening penetration, option d = made to penetrate another person’s vagina/genital opening, option e = anal penetration, and f = made to penetrate another person’s anus. Example items from this scale include, "Someone misused their position of authority over me to penetrate my vagina/genital opening".
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Timepoint [1]
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We will assess this outcome at baseline, 3-months post and 6-months post intervention
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Secondary outcome [2]
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Attitudes related to sexual violence
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Assessment method [2]
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We will use the Objectifying Women and Disregarding Consent (OWDS) scale to measure changes in students’ attitudes (Coumarelos et al., 2023). The OWDS is a subscale of the NCAS. It measures changes in beliefs that objectify women and disregard the importance of consent. This scale has 15 items on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree).
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Timepoint [2]
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We will assess this outcome at baseline, immediate post intervention, 3 months and 6 months post intervention.
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Secondary outcome [3]
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Sexual violence perpetration
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Assessment method [3]
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We will measure perpetration using the Australian Institute of Criminology’s Perpetration of Sexual Violence in a Community Sample of Adult Australians survey (Doherty and Dowling, 2024). This is a survey that has been used with an Australian sample which gives it additional local relevance. It measures perpetration using behaviourally specific items. Example items include, Have you ever kissed someone when they didn’t want you to? The use of behavioral-specific questions is also a key feature of this scale and is part of why the scale is a good fit for our study.
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Timepoint [3]
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We will assess this outcome at baseline, 3 months and 6 months post intervention.
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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.
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
There are no exclusion criteria
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/07/2025
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Actual
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Date of last participant enrolment
Anticipated
4/08/2025
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
1600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Social Services
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321300
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Country [1]
321300
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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La Trobe University Human Ethics Committee
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Ethics committee address [1]
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https://www.latrobe.edu.au/researchers/research-office/ethics/human-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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10/04/2025
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Approval date [1]
317454
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Ethics approval number [1]
317454
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Summary
Brief summary
In this study, we are evaluating the effectiveness of a sexual violence prevention program called CaRE (Consent and Relationship Education), designed for university students living in student accommodation. The program aims to improve students’ knowledge, attitudes, and behaviours related to consent and sexual violence. There are three groups in the study: one group will receive four CaRE sessions, another group will do a shorter version with three sessions, and the third group will not receive the program during the study but will have the chance to do the program later. By comparing outcomes across these groups, we aim to understand the impact of the CaRE program and whether the full or shorter version produces stronger outcomes. We anticipate that students who participate in the program will show increased knowledge of sexual violence, improved confidence and skills in negotiating consent and respectful relationships, and reduced endorsement of harmful attitudes and behaviours.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Leesa Hooker
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Address
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La Trobe University, Edwards Road, Flora Hill, Victoria, 3552
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Country
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Australia
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Phone
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+610354447984
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Innocent Mwatsiya
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Address
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La Trobe University, Plenty Road, Bundoora, Victoria, 3086
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Country
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Australia
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Phone
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+61415390941
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Innocent Mwatsiya
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Address
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La Trobe University, Plenty Road, Bundoora, Victoria, 3086
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Country
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Australia
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Phone
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+61415390941
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Fax
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Email
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[email protected]
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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.
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