Clinical Research Directory

Implementation Study With Embedded RCT of a Digital System of Parenting Support Within Government Services in South Africa

ParentText, a WhatsApp-based parenting support programme, is designed as a universal intervention to improve parent-child relationships (module 1) and promote child safety (module 2). The SWIFT study is an explanatory sequential time series design with an embedded randomised controlled trial. The time-series design aims to assess whether a digital parenting support programme, ParentText, can be embedded effectively into the regular services offered by the Department of Health and Wellness in the Western Cape, South Africa, and to explore factors affecting parent engagement. The embedded randomised controlled trial tests whether the second module affects sexual violence reduction against children. Participants include caregivers 18 years and older, living in South Africa, and caring for at least one child aged 2 to 17 years. The primary outcome measures of the study are both implementation 1): Assessing which of four approaches to advertising the ParentText programme leads to the highest rates of programme uptake, engagement, and completion; and programmatic: Testing the effectiveness of the additional Child Safety Module in 2) - reducing child sexual violence vulnerability, 3) - increasing child sexual violence risk planning and 4) - reducing child sexual violence exposure. The secondary outcomes assess changes in programme users' self-reported parenting behaviour in terms of 1) positive involvement, 2) positive parenting, 3) parent mental health, 4) parent support of education, 5) caregiver child/ adolescent communication, 6) online safety, 7) harsh parenting, 8) child or adolescent behavioural problems; and assessing users' experience of the 9) accessibility of the chatbot, 10) acceptability of the chatbot; and 11) adolescents' report of their sexual violence risk and safety planning communication.. In the first period of the time series design, participants will be recruited via posters, which provide a WhatsApp number for the programme, at their local clinic. Once they join, they will be provided with information on the study and be invited to consent to participate. If they consent, they will complete a baseline survey and then be able to move on to the first 5-day module. On consent to the study, participants will be placed randomly into either the group that receives the second module (intervention group) or a control group that will receive the module only after the study is completed. Both the intervention group and the control group receive the one-month and three-month surveys. In the second, third, and fourth time periods, everything remains the same except the encouragement method. In the first time period, only posters were used for recruitment. Within the second period, one month later, recruitment will be via both posters and additional encouragement from clinic staff. Clinic staff will encourage either verbally or by providing the caregiver with a flyer during their clinic visit. Throughout both these recruitment periods (1) and (2), caregivers who have completed the programme can share it on social media by posting predesigned tiles that include the joining information for the chatbot. Should our ideal sample size (4,000 participants) not be reached through these mechanisms, there will be an additional time period (3-4 weeks; time period three) during which the study team will advertise directly on Facebook. Finally, should our sample size not be reached in this third period, there will be a fourth time period of advertising that offers ZAR50 (approximately USD3) in airtime to those who sign up. This ZAR50 will be provided in sums of: ZAR15 for completing each of the baseline and one-month questionnaires, and ZAR20 for completing the three-month questionnaire. Once the three-month questionnaires are completed, participants will also be invited to a focus group discussion or telephonic interviews. Participants will be purposively selected from the group of participants who consent to the qualitative data collection phase. The focus groups will be conducted with participants residing in the Western Cape province, who completed one or both modules, and will discuss topics such as their experience of the ParentText programme, and the encouragement. For the telephonic interviews, participants will be purposely selected for interviews, looking at a) caregivers' experience of the child safety module, b) reasons for engaging/not engaging with the programme, and c) which referral services they accessed. Further, adolescents (over the age of 12 years) will be recruited via their caregivers - upon completion of the 3-month survey, parents or legal guardians will be asked to provide consent for the team to contact their adolescent to undertake a telephonic survey and, in some cases, a qualitative interview with them. Teens will complete informed assent.

Centering Gender Affirming Resources in Higher Education

Centering gender Affirming Resources in higher Education (CARE) project is nested within the parent study "Reducing Alcohol Involved Sexual violence in higher Education" (RAISE; R01 AA023260; NCT05185440). CARE is a pilot cluster-randomized trial that centers trans and gender diverse (TGD) students who are at elevated risk for SV and hazardous drinking. CARE tests a novel college health and counseling center (CHC) training program designed to improve provider knowledge about TGD individuals, increase their self-efficacy and use of trans-inclusive practices. This includes an evaluation of the feasibility, acceptability, appropriateness, and usability of CARE's training intervention for college health and counseling center providers. This research will produce the first rigorously evaluated TGD-focused CHC provider training which has the potential to increase the accessibility of CHC's for TGD university students- ultimately lowering rates of alcohol use and SV among this disproportionately impacted population.

Reducing Alcohol Involved Sexual Violence in Higher Education

This cluster-randomized controlled trial across 28+ college campuses focuses on undergraduate college students at elevated risk for sexual violence and hazardous drinking (i.e., students with prior history of sexual violence, students who are sexual or gender minority, and students with disabilities). "Reducing Alcohol Involved Sexual violence in higher Education (RAISE)" is a longitudinal study that will test research-informed strategies to improve implementation of a prevention intervention in college health and counseling centers, integrate a safety decision aid (via computer or mobile device) to more directly target harm reduction among students particularly vulnerable to hazardous drinking and SV, and evaluate campus policies that increase accessibility and uptake of confidential services for students. This is the first study to situate a sexual violence prevention intervention in college health and counseling centers to address two significant public health concerns -- alcohol-involved sexual violence and hazardous drinking on college campuses.

Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children

The overall goal of the five-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project (SMFP)'s READY to Stand (RTS)© curriculum with an eye toward widespread dissemination to other U.S. communities, if deemed effective. Broadly, the investigators seek to determine the effect participation has on students: reductions in commercial sexual exploitation of children (CSEC) perpetration (the primary outcome); reductions in CSEC victimization, teen dating violence (TDV), and sexual violence victimization and perpetration; as well as increases in bystander intervention in CSEC situations compared to participants in the control condition (secondary outcomes).

Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence

The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI/AN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and/or PTSD symptoms (primary outcomes). Previous research with non-AI/AN women finds that ESD reduces depression and PTSD symptoms, but no research has examined ESD among AI/AN survivors despite calls from our tribal partners to implement ESD with AI/AN adult women survivors. The investigators have assembled an interdisciplinary expert team and Elders/Traditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.

Evaluation of the Close to Home Program in California

Investigators propose to rigorously evaluate the Close to Home (C2H) model via a cluster-matched control trial across 18 diverse communities (9 C2H, 9 control) in California via collection and analyses of social network, school-based and social media data. Close to Home is a primary prevention community mobilization model implemented in 10 communities across California that engages community members across multiple sectors and social networks to strengthen community connections and shift social norms regarding sexual violence (SV), but has never been rigorously evaluated. C2H moves beyond criminal justice, lobbying, or school-based curricular approaches, taking a true community-level and community-led approach. This is a five-year project, funded by the Centers for Disease Control and Prevention (CDC) for 3 years with competitive awards for years 4 and 5, and is conducted in partnership with the California Department of Public Health (CDPH) and ValorUs (formerly CALCASA). The University of California, San Diego (UCSD) and CDPH partnership is uniquely poised to conduct the first rigorous evaluation of C2H in California at this time.

Evaluation of State-Level Sexual and Gender Minority Laws for the Primary Prevention of Sexual and Intimate Partner Violence Among Sexual and Gender Minority Youth in the U.S.

The goal of this observational study is to learn how state-level laws related to sexual and gender minority (SGM) youth affect the risk of sexual violence (SV) and intimate partner violence (IPV) among sexual minority (SM) youth in the United States. The study looks at both supportive laws (such as bans on conversion therapy and anti-bullying protections) and restrictive laws (such as limits on gender-affirming care) passed between 2017 and 2025. The main questions it aims to answer are: Part 1: * Do supportive SGM laws lower the risk of SV/IPV among SM youth? * Do restrictive SGM laws raise the risk of SV/IPV among SM youth? * Does the social climate in a state (such as levels of stigma toward SGM people) change how these laws affect SM youth? Part 2: -How do SGM youth themselves describe the ways that laws and social climates affect their safety and wellbeing? Part 1 - Quantitative analysis: Researchers will use existing, publicly available survey data from the Youth Risk Behavior Surveillance System (YRBSS) to compare changes in SV/IPV risk among SM youth across states that adopted different types of SGM laws over the period of 2017-2025. No participants are enrolled for this part. Part 2 - Qualitative interviews: Researchers will conduct one-on-one interviews with approximately 30 SGM youth ages 13-18 living across U.S. states with varying levels of adoption of supportive SGM laws. Each youth will take part in one 60-minute interview. Youth will be asked about their views on how laws and social climates affect safety, stigma, and access to resources. Youth will not be asked to share personal experiences of violence.

Evaluating the Efficacy of a New Sexual Violence Prevention Program With College Students

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.

PAIRS: Friend-Based AISA Intervention

This Phase 2 trial will to examine the efficacy of a brief dyad-based motivational interview (PAIRS MI) delivered to friend dyads with an active treatment-as-usual condition, and a 1-year follow-up.

Testing STAR and TextSTAR: A Randomized Controlled Trial

The goal of this clinical trial is to learn whether a video given for recent sexual assault survivors and/or a 3-week text messaging intervention with similar content is effective at reducing mental health problems and substance misuse following the assault.

Collaborative Opportunities for Reducing Alcohol and Sexual Violence Together

The goal of this clinical trial is to test if a modified peer-based motivational intervention (the Military PAIRS; MPAIRS) is reasonable and practical for military contexts. The main questions it aims to answer are: * Does it works to reduce SV? * Does it works to reduce risky drinking? To test this, participants will answer questions about their SV history and risky drinking. Then they will be given MPAIRS. After 1 month, they will be asked about their SV history and risky drinking again.

Motivations, Attitudes, and Perceptions Study

The goal of this clinical trial is to compare the impact of providing participants with 1. A recently developed protocol for motivating bystanders to intervene to help others who are in sexual risk situations (Motivate-the-Bystander) alone 2. Motivate-the-Bystander with an alcohol component focused on reducing drinking behaviors (Motivate-the-Bystander+Alcohol) 3. A control condition focused on reducing stress The main questions it aims to answer are: * Is Motivate-the-Bystander more effective than the attention control for increasing bystander behaviors? * Is Motivate-the-Bystander+Alcohol more effective than MTB alone for increasing bystander behaviors? * Is Motivate-the-Bystander+Alcohol more effective than Motivate-the-Bystander alone for decreasing alcohol use during bystander intervention opportunities? Participants will: * Complete online measures (e.g., self-reported bystander behaviors, past bystander training, history of bystander intervention attempts, sexual experiences, drinking behaviors, and other substance use behaviors) * Complete either MTB, MTB+ALC, or the attention control condition online * Complete the virtual reality simulation in the lab * Complete electronic daily diary follow-up surveys about alcohol use and bystander intervention

Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France

Women seeking asylum (WSA) are overexposed to sexual violence (SV) in their countries of origin, along migration routes, and within host countries. This overexposure does not cease upon arrival in host countries; on the contrary, the first months following arrival are characterised by heightened vulnerability, with an increased incidence of sexual violence, particularly among women with a prior history of victimisation. Sexual violence has major consequences on physical health, mental health, quality of life, and healthcare utilisation, and generates substantial individual and societal costs. International organisations, including the United Nations High Commissioner for Refugees, have identified the prevention of sexual violence and the improvement of care for survivors as public health priorities. Previous work suggests that addressing sexual violence within primary care, when embedded in a comprehensive, culturally informed, and coordinated approach integrating medical, psychological, social, and medico-legal dimensions, may contribute to preventing the occurrence or recurrence of sexual violence in host countries. However, no comparative study has yet evaluated the effectiveness of such a coordinated model of care on the prevention of sexual violence among women seeking asylum, nor assessed its efficiency or transferability. The primary objective of this study is to evaluate the effectiveness of a coordinated, transcultural, multidisciplinary outpatient care model on the prevention of sexual violence occurring in host European countries among women seeking asylum.

Evaluation of the Impact of Participation in a Psycho-education Program for Victims of Sexual Violence

Evaluation of the impact of a psycho-education program for victims of sexual violence, to determine the most efficient model to patients.

Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments

The goal of this project is to evaluate the effectiveness of Safe Night Out, a community-level primary violence prevention program offered in drinking establishments in the Sacramento region of California. The main questions this project aims to answer are: 1) Does the Safe Night Out program reduce incidents of sexual violence and intimate partner violence among patrons? 2) Does the Safe Night Out program increase incidents of safety checks of patrons by staff participants? To address these questions, we will enroll 150 staff participants and 500 patron participants from 25 drinking establishments that have implemented the Safe Night Out program (\~3 staff participants and 10 patron participants per drinking establishment) and 25 drinking establishments that have not implemented the Safe Night Out program (\~3 staff participants and 10 patron participants per drinking establishment). Participants will complete a baseline and three 6-month follow-up assessments, until 18 month-follow-up.

The Efficacy of the SUN Program in Adolescents

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.

Developing and Testing a Trauma-Informed Exercise Intervention for Women Veterans With Histories of Sexual Violence

Exposure to sexual violence disproportionally impacts women Veterans and can have profound negative impacts on daily functioning. Current treatments for sexual violence focus on psychiatric symptoms and ignore frequently co-occurring physical and psychosocial concerns. Exercise can improve trauma-related physical, mental, and psychosocial health conditions and may help women who have experienced sexual violence. Yet, women Veterans experience many barriers to participating in exercise and prefer interventions that are tailored to their preferences. This proposal will develop and test an exercise intervention tailored specifically to women Veterans who have experienced sexual violence. Treatment development will be informed by women Veterans with histories of sexual violence and their providers. Feasibility and acceptability will be tested, and outcomes will be explored to inform future research. This intervention is urgently needed to address gaps in integrative care and persistent trauma-related health concerns among women Veterans with histories of sexual violence.

The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).

TThe main objectives of this research project are twofold: (1) to conduct a narrative review of the scientific literature on the efficacy and effectiveness of psychological interventions for reducing acute post-traumatic stress symptoms in survivors of sexual violence, and to provide a solid theoretical framework on the consequences of sexual victimization and the use of EMDR interventions in this population; and (2) to develop and test an adapted version of the ASSYST protocol of Jarero´s team for survivors of sexual violence (ASSYST-SV), evaluating its effectiveness and feasibility in reducing acute stress symptoms in women who have experienced sexual violence. This is an exploratory quasi-experimental study with a single-group pre-post design and follow-up assessments. The intervention will be delivered to women receiving care in specialized services for survivors of gender-based violence in Catalonia and Madrid. Assessments will be conducted at three time points: pre-intervention, post-intervention, and three-month follow-up. Data will be collected through a combination of clinician-administered and self-report questionnaires. This trial is part of a larger research project (NCT05619822) that includes several related studies. Each study addresses a specific population and/or intervention, but all share the overarching aim of examining the efficacy of a comprehensive third-generation protocol for individuals with comorbid trauma and other mental health conditions.

How do Adults Sexual Offender Against Pre-pubescent Minors Perceive the Notion of Consent Based on the Account of Their Lived Experience ? (SOconsent)

In 2024, the police and gendarmerie recorded 12,260 victims of sexual violence, an increase of 7% compared with 2023. In 2019, 36,000 cases of sexual violence (rape or sexual assault) were handled by the public prosecutor's office. In 53.3% of cases, sexual violence was committed against minors. In 95% of cases, the perpetrators were male. The word is getting out about sexual violence, bringing the subject of consent to the forefront of media and scientific news. Even if the word is common, its definition is subtle, its understanding complex and many factors can influence its perception, including sex education, psychosocial skills and adherence to gender stereotypes. Research has shown that most people define sexual consent in the context of an oral conversation. However, studies show us that this is not what is done in practice: sexual consent or refusal is most often non-verbal and indirect. No studies have been carried out on consent in a population of perpetrators of sexual violence against minors. It is know that perpetrators of sexual violences exhibit alexythmias and cognitive distortions in the area of sexuality. The issue of consent is crucial, since perpetrators of sexual violences may believe that prepubescent children are capable of consenting to a sexual act. The aim of this study is to obtain a better analysis of the mechanisms, situations, facilitating factors, representations, sensitive perceptions and attitudes that lead perpetrators of sexual violences of minors to experiment with consent in their relationships. A better assessment of their understanding of consent and the factors that may have influenced it could have an impact on primary, secondary and tertiary prevention, as well as on treatment, and avoid potential new acts.