Evaluating the Efficacy of a New Sexual Violence Prevention Program with College Students (MOON Program)

March 13, 2025 updated by: Universidade do Porto

The Efficacy of a New Sexual Violence Prevention Program with College Students: a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Porto, Portugal
        • Recruiting
        • University of Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

-

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Participants allocated to this arm will receive intervention (i.e., will participate in the MOON sessions).
Behavioral: MOON Program
The MOON Program aims to contribute to the primary prevention of sexual violence among young university students. The program aims to achieve this goal by promoting bystander attitudes and behaviors through psychoeducation and skills training that enable participants to be active agents in this process. During the sessions, beliefs that legitimize violence will be deconstructed and skills such as communication about consent and empathy will be promoted. The MOON program consists of five online sessions, which are intended to be completed autonomously on a weekly basis. Throughout the sessions, participants will learn on the following topics: SV and consent, gender stereotypes, SV myths and bystander attitudes and behaviors.
No Intervention: Control Group
Participants allocated to this arm will be part of a control group, not receiving intervention and participating exclusively in the assessment time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bystander Attitudes
Time Frame: 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.
Bystander attitudes - Bystander Attitudes Scale - Revised (BAS-R) assesses bystander attitudes in SV scenarios (e.g., "Confront a friend if I hear rumors that they had forced someone to have sex"). For each scenario, participants are asked to indicate to what extent the described is acceptable according to a 5-point Likert scale that ranges from (1) = "Not acceptable" to (5) = "Extremely Acceptable". This instrument originally consisted of a 4-factor model categorizing items/scenarios by (1) High-risk Situations, (2) Post-assault Support for the Victim; (3) Post-assault Reporting of the Perpetrator; and (4) Proactive Opportunities. The Portuguese version of the measurement consists of 14 items organized into three similar subdimensions: (1) High-risk Situations, (2) Victims Support/Protection Behaviors, and (3) Proactive Opportunities.
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.
Bystander Behaviors
Time Frame: 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.
Bystander behaviors - Bystander Behaviors Scale - Revised (BBS-R) assesses bystander behaviors within SV scenarios through 16 self-report items (e.g. "Say something to a friend who is taking a drunk person back to their room at a party"). For each scenario participants are asked if they ever been in the described situation and the response varies across "Yes", "No" and "I haven't been in that situation". The original measurement instrument is organized by a 2-factor model contemplating (1) Intervention Opportunities and (2) Proactive Opportunities.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Empathy
Time Frame: 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.
Empathy - Empathy is to be measured with three items (see Milfont & Sibley, 2016). The items correspond to different affirmations (i.e., "I sympathize with others' feelings"; "I am not interested in other people's problems," reversed score; "I feel others' emotions"). Participants are asked to indicate their agreement with each statement accordingly to a seven-point Likert-type scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree).
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.
Myths about sexual violence
Time Frame: 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.
Myths about sexual violence will be assed with the sexual violence myths Scale. The scale assesses the subject's degree of tolerance/acceptance of the use of SV. The items are organized into five different factors that allow a better understanding of the specific beliefs underlying the tolerance to SV. The measurement includes items such as "Some people deserve to be raped" and "Some people get sexual pleasure when they are raped". Participants are asked to rate their agreement to each statement accordingly to a Likert scale ranging from 1 ("Completely Disagree") to 5 ("Completely Agree").
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.
Attitudes about gender roles
Time Frame: 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.
Gender role attitudes - Social Role Questionnaire (SRQ) assesses attitudes toward social roles. The scale includes items such as "People can be both aggressive and nurturing regardless of sex"; "Men are more sexual than women"; and "Mothers should work only if necessary." Respondents are asked to indicate how much they agree with each item by choosing a percentage range that varies between 0% and100%, with increments of 10%.
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.
Sexism
Time Frame: 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.
Sexism - Inventory of Ambivalent Sexism (IAS) allows the identification of beliefs related to sexist practices, including the sub scale of hostile sexism (i.e., more visible sexual discrimination - e.g. "Women are too easily offended") and the sub scale benevolent sexism (i.e., more subtle pejorative attitudes - e.g. "Women, compared to men, tend to have a superior moral sensibility"). The responses vary within in a Likert scale from 1 ("Completely Disagree") to 5 ("Completely Agree").
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.
Social Desirability
Time Frame: 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.
Social Desirability Scale - EDS-20 assesses behaviors and attitudes considered socially desirable, involving the denial of negative characteristics and the attribution of positive qualities through 20 dichotomous response items ("Yes" / "No").
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Aveiro University
Foundation for Science and Technology, Portugal
CINEICC - Center for Research in Neuropsychology and Cognitive Behavioral Intervention
Center for Psychology at the University of Porto, Portugal

Investigators

  • Study Director: Joana Carvalho, PhD, William James Research Center, Department of Education and Psychology, University of Aveiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MOONProgram
  • 2022.12638.BD (Other Grant/Funding Number: Foundation for Science and Technology)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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