NCT06830278

Brief Summary

This research project will develop, deliver, and evaluate a new school-based sexual violence prevention program for high-school adolescents. The SUN program (Stand Up Now against sexual violence) aims to prevent the occurrence of sexual violence among adolescents. The program approaches sexual violence as a complex phenomenon which occurs in many contexts throughout life. This program approaches specific concepts associated with sexual violence, such as sexual consent, while acknowledging the association between this form of violence and other violent phenomena. The program uses a bystander approach to support adolescents in the development of bystander attitudes and behaviors, which can be used in situations where the risk of sexual violence may be present. These may include behaviors such as confronting someone who is trying to take advantage of another person or reporting someone who committed sexual violence. The program aims to reduce myths associated with sexual violence, to increase empathy in this context and to improve bystander skills. Program sessions will combine group discussions with skills-building exercises. This study will apply the SUN program in school settings and compare the adolescents who will take part in the program with adolescents who will not. The study will evaluate changes in sexual violence myths, sexism, empathy, and bystander attitudes and behaviors. The authors hypothesize that by decreasing myths associated with sexual violence and sexism, and by increasing empathy in this context, the program will be able to increase the adolescents' capacity to intervene in real-world situations to prevent sexual violence (i.e., bystander attitudes and behaviors). Additionally, the programs' acceptability will be assessed through focus groups conducted with students. It is expected that this project will improve scientific knowledge regarding sexual violence prevention.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 28, 2025

Status Verified

October 1, 2025

Enrollment Period

1.5 years

First QC Date

December 23, 2024

Last Update Submit

November 21, 2025

Conditions

Keywords

AdolescentsBystandersPreventionPsychoeducationSexual ViolenceSchool settingsSkills training

Outcome Measures

Primary Outcomes (2)

  • Bystander attitudes

    Bystander attitudes - Bystander Attitude Scale-Revised (BAS-R) The Bystander Attitude Scale-Revised (modified version) is a self-report survey that measures bystander attitudes using 19 items (McMahon et al., 2014). This study uses a recent adaptation of this scale into Portuguese for adolescents, using only 13 items (in preparation for publication). The scale uses several items that capture a diverse range of bystander behaviors in terms of low and high risk of violence, timing of the intervention and proactive or reactive behaviors. An item example would be: "Report a friend to the police if I heard rumors that they had forced someone to have sex". In this survey, participants are asked to rate how acceptable a behavior is for them (i.e., whether they are favorable to that behavior) on a Likert scale from 1 (not acceptable) to 5 (extremely acceptable) (McMahon et al., 2014).

    All primary outcome measures will be assessed at baseline (1 week before the first session of the SUN), post-test (1 week after the last session of the SUN), and three, six and nine months after pos-test (follow-up assessments).

  • Bystander behaviours - Bystander Behavior Scale-Revised (BBS-R)

    The Bystander Behavior Scale-Revised (modified version) is a self-report survey similar to the BAS-R but which measures bystander behavior. Items are the same but participants are asked to report whether they have had those behaviors in the previous year (scale: "Yes", "No", "I wasn't in that situation") (McMahon et al., 2014).

    All primary outcome measures will be assessed at baseline (1 week before the first session of the SUN), post-test (1 week after the last session of the SUN), and three, six and nine months after pos-test (follow-up assessments).

Secondary Outcomes (4)

  • Empathy

    All secondary outcome measures will be assessed at baseline (1 week before the first session of the SUN), post-test (1 week after the last session of the SUN), and three, six and nine months after pos-test (follow-up assessments).

  • Sexual violence myths

    All secondary outcome measures will be assessed at baseline (1 week before the first session of the SUN), post-test (1 week after the last session of the SUN), and three, six and nine months after pos-test (follow-up assessments).

  • Sexism

    All secondary outcome measures will be assessed at baseline (1 week before the first session of the SUN), post-test (1 week after the last session of the SUN), and three, six and nine months after pos-test (follow-up assessments).

  • Social Desirability

    All secondary outcome measures will be assessed at baseline (1 week before the first session of the SUN), post-test (1 week after the last session of the SUN), and three, six and nine months after pos-t (follow-up assessments).

Study Arms (2)

Control Group

NO INTERVENTION

The students in the control cluster continue scheduled school activities as usual.

Experimental group

EXPERIMENTAL

Participants in the intervention cluster take part in the SUN Program.

Behavioral: The SUN Program

Interventions

The SUN ProgramBEHAVIORAL

The SUN Program is a manualized bystander program for high-school adolescents. The program includes ten 50-to-60 minute weekly sessions. The central contents of the program include sexual and reproductive rights, sexual violence throughout the lifespan in different contexts, bystander attitudes and behaviors, and empathy. Every session includes psychoeducation components as well as skills-training moments. The sessions must be delivered by two psychologists with supervision. Session contents are divided as following: Session 1: Introduction to sexual violence and sexual rights; Session 2: Sexual violence: behaviors and contexts, Session 3: Sexual consent; Session 4: Sexual violence myths; Session 5: Sexual violence in intimate relationships; Session 6: The role of the bystanders; Session 7: The bystander effect; Session 8: Bystander intervention; Session 9: Empathy; Session 10: Summary

Experimental group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adolescents
  • Enrolled in high schools in grades 10th and 11th
  • Enrolled in schools of the North or Center of Portugal
  • Fluent in Portuguese (spoken and written)

You may not qualify if:

  • Presence of a serious developmental disorder, physical or mental health issue that interferes with the participation in the sessions, as reported by the caregivers or by the school staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Four different schools in Porto and Aveiro districts

Porto, Portugal

Location

Related Publications (8)

  • Torazzi E, Merelli V, Barbara G, Kustermann A, Marasciuolo L, Collini F, Cattaneo C. Similarity and Differences in Sexual Violence Against Adolescents and Adult Women: The Need to Focus on Adolescent Victims. J Pediatr Adolesc Gynecol. 2021 Jun;34(3):302-310. doi: 10.1016/j.jpag.2020.11.018. Epub 2020 Nov 28.

    PMID: 33259887BACKGROUND
  • Piolanti A, Jouriles EN, Foran HM. Assessment of Psychosocial Programs to Prevent Sexual Violence During Adolescence: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Nov 1;5(11):e2240895. doi: 10.1001/jamanetworkopen.2022.40895.

    PMID: 36346627BACKGROUND
  • Panisch LS, Faulkner M, Fernandez SB, Fava NM. Exploring How Trauma Is Addressed in Sexual Education Interventions for Youth: A Scoping Review. Health Educ Behav. 2020 Dec;47(6):880-893. doi: 10.1177/1090198120954398. Epub 2020 Sep 8.

    PMID: 32900237BACKGROUND
  • McMahon S, Allen CT, Postmus JL, McMahon SM, Peterson NA, Lowe Hoffman M. Measuring bystander attitudes and behavior to prevent sexual violence. J Am Coll Health. 2014;62(1):58-66. doi: 10.1080/07448481.2013.849258.

    PMID: 24313697BACKGROUND
  • Gottfredson DC, Cook TD, Gardner FE, Gorman-Smith D, Howe GW, Sandler IN, Zafft KM. Standards of Evidence for Efficacy, Effectiveness, and Scale-up Research in Prevention Science: Next Generation. Prev Sci. 2015 Oct;16(7):893-926. doi: 10.1007/s11121-015-0555-x.

    PMID: 25846268BACKGROUND
  • Carmo E, Brazao N, Carvalho J. The Primary Prevention of Sexual Violence Against Adolescents in School and Community Settings: A Scoping Review. J Sex Res. 2025 May;62(4):656-672. doi: 10.1080/00224499.2024.2367562. Epub 2024 Jun 28.

    PMID: 38940424BACKGROUND
  • Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.

    PMID: 22951546BACKGROUND
  • Barbara G, Albertini V, Tagi VM, Maggioni L, Gorio MC, Cattaneo C, Parazzini F, Ricci E, Buggio L, Kustermann A. Characteristics of Sexual Violence Against Adolescent Girls: A 10 Years' Retrospective Study of 731 Sexually Abused Adolescents. Int J Womens Health. 2022 Mar 3;14:311-321. doi: 10.2147/IJWH.S343935. eCollection 2022.

    PMID: 35273451BACKGROUND

Study Officials

  • Joana Carvalho, PhD

    William James Center for Research, Department of Education and Psychology, University of Aveiro

    STUDY DIRECTOR
  • Eunice Carmo, MSc

    Center for Psychology at University of Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants in the control groups take part in the scheduled in-person school activities, as usual. Participants in the intervention group take part in the in-person sessions of the SUN Program. This is a parallel design, so participants are part of the same group for the duration of the entire study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2024

First Posted

February 17, 2025

Study Start

June 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 28, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations