Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000483459p
Ethics application status
Submitted, not yet approved
Date submitted
30/04/2025
Date registered
20/05/2025
Date last updated
20/05/2025
Date data sharing statement initially provided
20/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The respectED Study: A cluster randomised controlled trial of a school-based intervention to prevent intimate partner and sexual violence among adolescents
Scientific title
The respectED Study: A cluster randomised controlled trial of a school-based intervention to prevent intimate partner and sexual violence among adolescents
Secondary ID [1] 314320 0
None
Universal Trial Number (UTN)
Trial acronym
respectED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intimate partner violence 337273 0
Sexual violence 337274 0
Condition category
Condition code
Public Health 333672 333672 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Schools assigned to the intervention group will implement the healthy relationships and consent program (respectED) in health education classes in Term 3 or Term 4 of 2025. The program involves five 40-minute lessons, delivered one week apart. Each lesson comprises an online cartoon component completed individually by students, followed by teacher-facilitated activities (e.g., class discussions, quizzes, role plays). There are also reflective activities and quizzes embedded in the cartoons to ensure student comprehension, critical thinking and engagement, and factsheets are provided at the end of each lesson that reinforce key content. All materials are developed/co-designed for this program and study specifically.

The program content covers key topics related to healthy relationships and consent, including respect, boundaries, emotional awareness, coercive control, bullying, gossip, digital abuse, and safe online behaviour. It aims to challenge harmful norms and attitudes, promote positive relationship skills, and increase emotional literacy. Through engaging cartoon storylines and interactive activities, students learn to recognise signs of unhealthy relationships, communicate effectively, and practice setting boundaries. The program also addresses common issues faced by adolescents, such as peer pressure, online coercion, and navigating romantic and platonic relationships.

Students and teachers access the intervention materials online via the respectED website. Teachers are provided with curriculum outlines, lesson summaries and implementation guides. No teacher training is required for the delivery of the program, teachers will be given an implementation plan and onboarding documents. They will also be able to seek support from trial staff and trial psychologist.

To track program fidelity, teachers will be asked to complete logbooks to document their implementation of the respectED program (i.e. timing, activities delivered, technical problems, other implementation details). Website analytics will provide objective data on the dose and timing of intervention delivery.
Intervention code [1] 330931 0
Prevention
Intervention code [2] 330932 0
Behaviour
Comparator / control treatment
Schools assigned to the control group will carry out health education as usual in their Health and Physical Education lessons. As consent education is mandatory in Australian schools, these schools serve as an ‘active control’. Teachers will complete a logbook documenting the amount and format of any relevant education delivered to their Year 9 students. Control schools will be offered access to the intervention at trial completion, so long as the program demonstrates efficacy and acceptability.
Control group
Active

Outcomes
Primary outcome [1] 341265 0
Attitudes toward intimate partner and sexual violence (composite measure)
Timepoint [1] 341265 0
Measured at baseline, post-intervention (5-weeks) and 6-month follow-up (primary end-point).
Primary outcome [2] 341507 0
Intimate partner violence victimisation
Timepoint [2] 341507 0
Measured at baseline, post-intervention (5-weeks) and 6-month follow-up (primary end-point).
Primary outcome [3] 341510 0
Cyber intimate partner violence victimisation
Timepoint [3] 341510 0
Measured at baseline, post-intervention (5-weeks) and 6-month follow-up (primary end-point).
Secondary outcome [1] 447805 0
Intimate partner violence perpetration (primary outcome)
Timepoint [1] 447805 0
Measured at baseline, post-intervention (5-weeks) and 6-month follow-up (primary end-point).
Secondary outcome [2] 447813 0
Cyber intimate partner violence perpetration (primary outcome)
Timepoint [2] 447813 0
Measured at baseline, post-intervention (5-weeks) and 6-month follow-up (primary end-point).
Secondary outcome [3] 447814 0
Positive relationship skills
Timepoint [3] 447814 0
Measured at baseline, post-intervention (5-weeks) and 6-month follow-up
Secondary outcome [4] 447815 0
Knowledge of intimate partner and sexual violence. This will be assessed as a composite outcome.
Timepoint [4] 447815 0
Measured at baseline, post-intervention (5-weeks) and 6-month follow-up
Secondary outcome [5] 447816 0
Program acceptability (student).
Timepoint [5] 447816 0
Post-intervention (5-weeks).
Secondary outcome [6] 447817 0
Program acceptability (teacher).
Timepoint [6] 447817 0
Post-intervention (5 weeks)

Eligibility
Key inclusion criteria
(i) Year 9 students (aged 14-16 years) attending participating schools in 2025/2026.
(ii) fluent in English.
(iii) provide informed active consent.
(iv) provide opt-out parental consent (non-government schools) or opt-in parent consent (government schools).
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) Schools with less than 70 enrolled Year 9 students in 2025/2026.
(ii) Students not fluent in English.
(iii) < 14 years of age.
(iv) Students unable to provide informed active consent.

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)
Allocation will be concealed. Schools will be randomly allocated to groups by an independent statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will generate an unpredictable, concealed random allocation sequence using the blockrand package in R (Snow & Snow, 2013). After schools’ consent and enrolment in the study, a biostatistician with no role in school recruitment will block randomise schools to study groups, with stratification by school gender mix (coeducational, predominately female [>60%], or predominately male [>60%]). The process of automatic randomisation removes researcher involvement, allows concealment from investigators and research personnel (blinded), except those with direct school involvement where blinding is not possible (e.g., Research Assistants who need to discuss intervention delivery with teachers). Twelve schools will be randomly allocated to the respectED intervention group and 12 schools to an active control group (health education as usual).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
The sample size calculations are based on a method to detect intervention-by-time interactions in longitudinal cluster randomized controlled trials (RCTs), as described by Heo & Leon (Heo & Leon, 2009). To detect differences between intervention and control groups across three measurement occasions, five schools and 350 students per group (control and intervention) are needed. This would provide 80% power to detect an effect size of 0.15, with an assumed correlation of 0.5 between measurements across time. This effect size is based on published effect sizes for the targeted behaviour with the lowest anticipated prevalence at baseline, specifically, IPV perpetration (33).To ensure sufficient power to detect these effects in subgroups of interest (e.g., boys and girls [~50%], and those who have dated romantically [~60%]), we would need 10 schools and 700 students per group, totalling 1,400 students at the final follow-up (12-months). Additionally, to account for potential school dropout (approx. 15%, or 3 schools) and student attrition (approx. 15%, or 210 students), we aim to recruit a minimum of 24 schools (12 schools per group) and 1,680 students at baseline. This recruitment strategy is based on our previous school-based prevention trials, where we observed high participation rates among students (e.g., 85% at 12 months)(Champion et al., 2023).
Statistical analyses:
Primary outcome analysis will be led by a biostatistician independent of the day-to-day running of the trial, and blind to the group randomisation. The evaluation of the intervention effects on primary outcomes will be conducted on an intention-to-treat basis, whereby all randomised students will be analysed in the groups to which they were originally assigned. Generalised mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes (e.g., logistic regression for dichotomous outcomes, Poisson regression for count outcomes, linear regression for continuous outcomes). Analyses will be conducted in R, using the lme4 package (Bates et al., 2015). To account for within-person and within-school dependency in the data, models will include participant and school as nested random intercepts, and participant and time as random slopes. We will also test different specifications of time (linear, quadradic & categorical) to determine the best fitting model for the data. Model fit will be compared using likelihood ratio tests, AIC, and BIC statistics. The effect of greatest interest will be the time × group interaction for the primary outcomes, which reflects the relative average 6-month change in the mean difference or log odds of the outcome for the intervention group compared to control, adjusting for baseline differences.
Due to loss to follow-up, we reasonably expect some outcome data to be missing. Mixed-effects models use maximum likelihood estimation (MLE), producing unbiased estimates when data is assumed to be missing at random. Missing data will be explored by examining baseline differences on the outcome and other potential confounding variables between those retained and those lost to follow-up.
To address our secondary objective of the spread of attitudes in peer groups, we will use stochastic actor-oriented models, implemented using the RSiena package in R (Ripley et al., 2013) to disentangle peer selection and peer influence effects of attitudes towards IPV and how these differ by intervention group. That is, we will examine if the intervention reduces clustering of harmful attitudes condoning violence attitudes among intervention schools, relative to control schools. This approach will allow us to gain a better understanding of the mechanisms driving intervention efficacy.

Analysis of any additional outcomes (e.g., moderators) will be reported in separate publications.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
14/11/2025
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
1680
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318746 0
Government body
Name [1] 318746 0
Department of Health and Aged Care - Medical Research Future Fund
Country [1] 318746 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321290 0
None
Name [1] 321290 0
Address [1] 321290 0
Country [1] 321290 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317361 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317361 0
Ethics committee country [1] 317361 0
Australia
Date submitted for ethics approval [1] 317361 0
30/03/2025
Approval date [1] 317361 0
Ethics approval number [1] 317361 0

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

Contacts
Principal investigator
Name 140802 0
Dr Siobhan O'Dean
Address 140802 0
The Matilda Centre for Research in Mental Health and Substance Use, Level 6 Jane Foss Russell Building, The University of Sydney, NSW, 2006
Country 140802 0
Australia
Phone 140802 0
+61423166563
Fax 140802 0
Email 140802 0
[email protected]
Contact person for public queries
Name 140803 0
Dr Amy-Leigh Rowe
Address 140803 0
The Matilda Centre for Research in Mental Health and Substance Use, Level 6 Jane Foss Russell Building, The University of Sydney, NSW, 2006
Country 140803 0
Australia
Phone 140803 0
+61 02 9036 4739
Fax 140803 0
Email 140803 0
[email protected]
Contact person for scientific queries
Name 140804 0
Siobhan O'Dean
Address 140804 0
The Matilda Centre for Research in Mental Health and Substance Use, Level 6 Jane Foss Russell Building, The University of Sydney, NSW, 2006
Country 140804 0
Australia
Phone 140804 0
+61423166563
Fax 140804 0
Email 140804 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.