Clinical trial NCT06887361: Evaluating the Efficacy of a New Sexual Violence Prevention Program with College Students
Official title: The Efficacy of a New Sexual Violence Prevention Program with College Students: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Violence
Keywords: Clinical trial
Sexual Violence
Prevention
College Students
Bystander Approach
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: University of Coimbra
name: Aveiro University
name: Foundation for Science and Technology, Portugal
name: Center for Psychology at the University of Porto, Portugal
First posted: 2025-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research project will develop, deliver, and assess the efficacy of a new sexual violence (SV) prevention program for college students. The MOON program (Moving ON against sexual violence) aims to prevent sexual violence amongst university students, who are known to be an at-risk population for this form of violence.

The MOON program follows a bystander approach, aiming to teach and capacitate young adults to be active agents of prevention within their communities. To do so, the program combines education on several SV-related topics with skills-training activities.

Throughout five online sessions, the participants will be educated on topics such as sexual violence and consent, gender stereotypes, SV myths and bystander attitudes and behaviors. The main goal is to promote discussion forums, increase the participants knowledge on these topics and deconstruct pre-conceived beliefs/ideas that promote societal tolerance and acceptance of SV The program follows a bystander approach to support young adults in the development of bystander attitudes and behaviors that will help them act in situations of risk of SV. To achieve this goal, the program sessions will also have a major focus on building bystander prevention skills through online practical exercises (e.g., training scenarios).

Finally, the program also focuses on promoting empathy towards others, specifically in the context of sexual violence prevention. This focus aims to deconstruct victim blaming narratives and to build victim-support skills, to enhance the students' sense of responsibility and their proclivity to act and help others in need. Being empathic towards others is perceived as a crucial component in the bystander decision-making to intervene.

This clinical trial will apply the MOON program with university students nationwide in the Portuguese context and compare the participants who will take part in the program (experimental group) with other students who will not (control group). Thus, the RCT will be conducted with the following goals:

1. To assess the treatment's efficacy, by evaluating the program's ability to significantly reduce gender stereotypes, sexism, and rape myths; and to significantly increase active bystander attitudes and behaviors and empathy towards other people.
2. To examine the extent to which any changes are maintained three, six and nine months after the program's completion.
3. To assess mechanisms of change, i.e., to test whether changes in cognitive outcomes, namely in rape myth endorsement, are associated with changes over time in behavioral outcomes, as bystander attitudes/behaviors.
4. To investigate the role of age and gender as moderators of change over time in SV perpetration, gender stereotypes, sexism, rape myths, bystander attitudes and behaviors and empathy.

Detailed description: Project Relevance:

Literature places evidence of consistently high rates of SV perpetration among university populations, highlighting the need to design prevention programs that target specifically this type of violence in this population. The delivery of the MOON program fits within the framework of human rights established internationally in the Istanbul Convention and aligns with the World Health Organization's recommendation of major focus on primary prevention for SV.

Design and Participants:

The present project consists of a randomized controlled trial (RCT). The study will be conducted following the guidelines by the CONSORT-SPI Group.

This project follows a longitudinal design. Participants will answer a set of self-report measures in five different time-points: one week before the beginning of the program (baseline), one week after the program's completion (post-test), and three, six and nine months after the post-test (follow-up assessments).

Power analysis showed that a sample of 179 participants will be necessary to detect medium effects with a significance level of .05 and a power of .95. The sample will include a minimum of 200 male and female participants. Inclusion criteria require participants to be 18 years old or older, to be fluent in the Portuguese language and to be attending college.

Inclusion criteria:

Participants must be 18 years old or older. All participants must be enrolled in a higher education institution in Portugal. Finally, participants will have to be fluent in written and spoken Portuguese.

Intervention:

MOON (MOving ON against sex violence) is a SV prevention program for college students. The MOON is an online program of five sessions which are meant to be completed autonomously on a weekly basis. To promote the development of active bystander attitudes and behaviors on the participants, they will be educated and complete different exercises on the following topics along the sessions: SV and consent, gender stereotypes, SV myths, empathy and bystander attitudes and behaviors.

The contents of each session are as follow:

1. Sexual Violence (Framing SV as a public health matter; informing about SV and its various forms and contexts it can occur in; and teaching about the importance of recognizing consented vs. non-consented sexual interactions.)
2. Pro-Social Attitudes (Defying myths and beliefs that promote tolerance to SV; understanding the barriers to the bystander intervention vs. learning strategies to overcome those barriers; and promoting the participants' pro-social attitudes.)
3. Empathy (Promoting empathy towards others; fostering the participants' sense responsibility to act; and introducing the role of the active bystander in the prevention of SV.)
4. Pro-Social Behaviors (Promoting pro-social bystander behaviors of the participants; and sharing and training practical examples of bystander intervention in SV incidents)
5. Bystander Skills (Training practical intervention skills and preparing the participants to be active agents of SV prevention).

Measures To assess the intended outcomes, several self-report measures will be combined into a survey: Bystander Attitudes and Behaviors Scales; three items to measure Empathy Social; Rape Myth Scale; Social Role Questionnaire; Inventory of Ambivalent Sexism and Desirability Scale.

Procedures According to the statistical power analysis, approximately 200 university students will be recruited. This study will be advertised through university mailing lists and on social media platforms. The program objectives and contents will be presented to the participants, and the research will follow upon informed consent. Students who voluntarily agree to participate in the study will start by completing the online self-report survey (evaluating gender stereotypes, sexism, SV myths endorsement, bystander attitudes and behaviors and empathy) on the week prior to the intervention (baseline). Due to the self-report nature of the measurements, a social desirability measure will also be included to control for potential bias of the participants responses. Afterwards, individual randomization of participants to each group (control and intervention) will be ensured using a randomization software (https://www.randomizer.org/). Each condition will include approximately 100 participants. This distribution accounts for possible and expected dropouts and ineligible participants. Students assigned to the intervention group will then complete the programs' sessions online during five weeks. Remaining participants will be assigned to the wait list control group. Students of both experimental conditions will also answer the survey at the post-test assessment (the week after the programs' completion) and at the three, six- and nine-months follow-ups. The moderator factors (age and gender) will be assessed exclusively at baseline. The programs' integrity will be ensured through: (a) specific intervention manual, (b) ongoing supervision of the process, and (c) direct assessment of the participants' adherence throughout the five weeks.

Data analysis:

All analysis will be carried out according to an intention-to-treat analysis. To assess treatment outcomes in the completers, a per-protocol analysis will also be carried out. Treatment and moderator effects will be analyzed Unconditional and Conditional Latent Growth Models. To examine mechanisms of change, two-wave latent change scores models will be performed. All analyses will be done through Mplus v.8.7.

Eligibility criteria: Inclusion Criteria:

18 years old or older Enrolled in a Portuguese university Fluent in Portuguese (written and spoken)

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Exclusion Criteria:

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Primary outcomes:
measure: Bystander Attitudes
timeFrame: Assessed at five different timepoints: (1) baseline - one week prior to the beginning of the program, (2) post-test - one week after the completion of the program and (3-5) follow-ups of three, six and nine months counting from the post-test assessment.
measure: Bystander Behaviors
timeFrame: Assessed at five different timepoints: (1) baseline - one week prior to the beginning of the program, (2) post-test - one week after the completion of the program and (3-5) follow-ups of three, six and nine months counting from the post-test assessment.
Secondary outcomes:
measure: Empathy
timeFrame: Assessed at five different timepoints: (1) baseline - one week prior to the beginning of the program, (2) post-test - one week after the completion of the program and (3-5) follow-ups of three, six and nine months counting from the post-test assessment.
measure: Myths about sexual violence
timeFrame: Assessed at five different timepoints: (1) baseline - one week prior to the beginning of the program, (2) post-test - one week after the completion of the program and (3-5) follow-ups of three, six and nine months counting from the post-test assessment.
measure: Attitudes about gender roles
timeFrame: Assessed at five different timepoints: (1) baseline - one week prior to the beginning of the program, (2) post-test - one week after the completion of the program and (3-5) follow-ups of three, six and nine months counting from the post-test assessment.
measure: Sexism
timeFrame: Assessed at five different timepoints: (1) baseline - one week prior to the beginning of the program, (2) post-test - one week after the completion of the program and (3-5) follow-ups of three, six and nine months counting from the post-test assessment.
measure: Social Desirability
timeFrame: Assessed at five different timepoints: (1) baseline - one week prior to the beginning of the program, (2) post-test - one week after the completion of the program and (3-5) follow-ups of three, six and nine months counting from the post-test assessment.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: University of Porto
Study officials:
affiliation: William James Research Center, Department of Education and Psychology, University of Aveiro
name: Joana Carvalho, PhD
role: STUDY_DIRECTOR
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