75 Clinical Trials for Various Conditions
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.
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.
This study is designed to pilot a text message (TM) delivered behavior change intervention to decrease binge drinking and to increase use of sexual violence (SV) harm reduction strategies among college students.
Study to provide evidence of efficacy for Rapid Resolution Therapy in symptoms of PTSD, Anxiety, and Depression in survivors of sexual violence.
This study evaluates the efficacy of a web-based program for female college freshmen ("RealConsent") in reducing their risk of sexual violence victimization. Half the participants will receive RealConsent-F and half will receive an attention-placebo control ("Stress and Mood Management").
Dating and sexual violence are significant public health concerns occurring on a continuum of severity across the lifespan, with serious consequences to victims and society. The present research advances the science of prevention by rigorously evaluating a comprehensive social norms marketing campaign to promote community-level change in dating and sexual violence in middle schools. Partnership between researchers and a CDC Rape Prevention and Education Program (RPE) funded agency is a core feature of this work, and aims to build community capacity to implement and evaluate violence prevention efforts, and promote the subsequent uptake of social norms marketing campaigns as a strategy for reducing dating and sexual violence among youth.
This research will examine if participation in a strengths-based curriculum, the Brothers as Allies program adapted from the Council for Boys and Young Men, reduces risk for future sexual violence perpetration among middle school-aged boys in New York State.
The purpose of this multiple baseline study is to evaluate the effectiveness of a comprehensive youth-led sexual violence (SV) prevention program, Youth Voices in Prevention (Youth VIP). The prevention program builds on youth-adult partnerships among middle and high school students in Rapid City, South Dakota. Consenting students will take part in a youth summit where they will be trained as popular opinion leaders to spread SV prevention messages among middle and high school youth and parents. Following the summit, youth will work in small groups focused on different aspects of evidence-based prevention strategies including bystander intervention, social marketing messaging, parent education, norms change, and social emotional learning. Multiple research methods will be used to examine implementation process and cost. In addition, consenting students will take six surveys across three years including several surveys before programming begins, and several to document Youth VIP outcomes after prevention programming takes place. Survey data from a demographically similar community will be used to assess changes over time among youth in Rapid City, SD. All phases of the project will be implemented with collaboration from a Research Programming Advisory Board of community members and professionals from Rapid City, SD.
The investigators have developed a game-based sexual violence prevention program that uses a bystander intervention approach. This program is called Bystander and was designed for use with high school students in grades 9-12. The goal of this research is to evaluate the efficacy and feasibility of Bystander when implemented in a school setting. The research will capture data on knowledge about sexual violence and harassment, as well as attitudes, self-efficacy, perceived social norms and behavioral intentions around bystander behaviors. This research will consist of a baseline survey, program participation, a immediate post-program survey, and a 3-month follow up survey with youth participants. It will also involve qualitative in-depth interviews with school staff and administration about the program.
The purpose of this randomized intervention pilot is to evaluate the relative efficacy of bystander training elements (delivery mode and integration of substance abuse prevention) among cohorts of incoming undergraduates at the University of Kentucky, a nationally recognized leader in addressing sexual violence through bystander intervention programming. Per university policy, all incoming undergraduates will participate in mandatory online training covering sexual violence awareness, bystander concepts, and alcohol use/abuse. Consenting students will be randomized to one of the following training conditions: 1. Green Dot Intensive Bystander Training (INT) or 2. Student Wellness Training (active control). Students in each condition will be followed for 9 months, one academic year.
Sexual violence (SV) and adolescent relationship abuse (ARA) are prevalent among adolescents and associated with poor health. Global health organizations highlight engaging men and boys in preventing violence against women as a potentially impactful public health strategy. This study aims to test, via a two arm cluster randomized controlled trial, a "gender transformative" SV/ARA perpetration prevention program among African American adolescent males ages 13-19 (target is high school age) implemented in a community-based setting. "Gender transformative" refers to a theory- and evidence-based approach to alter gender norms that foster SV/ARA while promoting bystander intervention (i.e., giving boys skills to interrupt abusive behaviors they witness among peers) to reduce SV/ARA perpetration. As the acceptance of SV and involvement in unhealthy sexual behaviors are associated with SV/ARA perpetration, this program integrates analysis of social norms that condone violence against women, sexual health promotion, and skills in bystander intervention -- an approach that has been implemented in multiple non-U.S. settings among young adult males with reductions in violence, development of more equitable gender attitudes, and less risky sexual behaviors. This will be the first test of such a gender transformative program among adolescent males in the U.S. Via a 2-arm cluster-randomized trial in youth-serving agencies (16 clusters, N=840 adolescent males ages 14-19), this study will assess the effectiveness of "Manhood 2.0" (proposed name for this gender transformative program) compared to a job skills curriculum. Three months after the end of the program (Time 2), compared to controls, youth will demonstrate increased positive bystander intervention behaviors (secondary outcome). Intermediate outcomes are: condom use self-efficacy; contraception use attitudes; recognition of abusive behaviors; gender-equitable attitudes; and intentions to intervene with peers. Nine months after intervention completion (Time 3), youth will report less perpetration of SV and ARA toward females (Primary Outcome) compared to controls. This study will provide urgently needed information about the effectiveness of a gender transformative program that combines healthy sexuality skills, gender norms change, and bystander skills to interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent males.
This study will offer the first formal assessment for sexual violence (SV) in the college student health center setting, developed for a high risk group of college students, and is designed to facilitate patient and provider comfort in discussing sexual violence and related abusive experiences (including the role of alcohol) via semi-scripted screening tools. The intervention specifically involves the training of all clinical staff (health educators, counselors, medical assistants, nurses, and clinicians) to deliver a universal education and brief counseling intervention titled GIFTSS (Giving Information for Trauma Support and Safety) to all clients seeking college health services integrated into usual clinical practice, provide universal education about SV regardless of disclosure, counsel clients on harm reduction strategies to reduce risk for SV, and provide supported referrals to sexual assault advocates, with the goal of reducing SV among college students.
This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R61 seeks to develop and test a brief video intervention to deliver during Sexual Assault Nurse Examiner (SANE) care and a brief text messaging intervention to deliver in the month after the assault to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.
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.
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.
This study utilizes implementation science principles to culturally adapt a pre-existing web-based application (WebApp) for use with college students. The ADAPT-ITT process will be utilized to adapt the WebApp to a diverse (race, ethnicity, gender/sexual identity) college population with a focus on life skills and holistic self-care as reinforcement to currently available primary prevention programming available to incoming students. The study hypothesis is that the adapted WebApp will be usable, acceptable, and students will be willing to use it as a reinforcement to current university primary prevention programming. The study team will also monitor retention of participants over the academic year. This is a repeat pilot test to evaluate changes implemented to the WebApp after the initial pilot during the 2017-2018 academic year.
This study utilizes implementation science principles to culturally adapt a pre-existing web-based application (WebApp) for use with college students. The ADAPT-ITT process will be utilized to adapt the WebApp to a diverse (race, ethnicity, gender/sexual identity) college population with a focus on life skills and holistic self-care as reinforcement to currently available primary prevention programming available to incoming students. The study hypothesis is that the adapted WebApp will be usable, acceptable, and students will be willing to use it as a reinforcement to current university primary prevention programming. The study team will also monitor retention of participants over the academic year.
The purpose of this randomized intervention pilot is to evaluate the relative efficacy of bystander training elements (delivery mode and integration of substance abuse prevention) among cohorts of incoming undergraduates at the University of Kentucky, a nationally recognized leader in addressing sexual violence through bystander intervention programming. Consenting students will be randomized to one of the following training conditions: 1. In-person Green Dot Intensive Bystander-based Sexual Violence Prevention Training (GreenDot); 2. In-person Green Dot Intensive Bystander Training combined with Substance Abuse Prevention Training; 3. Online Bystander-based Sexual Violence Prevention Training (Haven), and; 4. Online Substance Abuse Training (AlcoholEdu).
Bystander interventions, recognized as promising violence prevention strategies, are unique in their engagement of all community members to 1) recognize situations that may become violent and 2) learn to safely and effectively intervene to reduce violence risk. Based on their promise, the Campus Sexual Violence Elimination Act (SaVE) now requires all publicly-funded colleges to provide bystander intervention. With SaVE's policy intervention requiring bystander interventions, a "natural experiment" has arisen to determine the relative efficacy of students' bystander training across multiple colleges. Investigators propose a quasi-experimental design (using fractional factorials) to evaluate the relative efficacy of three bystander interventions to reduce violence in college communities. Green Dot will be one of three bystander interventions evaluated. A recent rigorous evaluation has found that Green Dot is associated with a 20-40% reduction in VAW in college and high school settings. In aim 1, investigators will compare the relative efficacy of bystander interventions to a) increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce interpersonal violence victimization and perpetration, and d) increase program cost effectiveness. The three main bystander groups compared will be: exclusively online training, Green Dot (speeches and intensive bystander training), and other skills-based bystander training. Program efficacy data will be obtained from student surveys, campus crime statistics, and surveys with college staff and administrators responsible for selecting and implementing bystander interventions. In aim 2, investigators seek to grow communities of VAW prevention researchers. Researcher communities will form through researchers' engagement with college recruitment, survey design, data collection and analyses. Specifically investigators will determine the efficacy of this program to increase VAW prevention research productivity defined as a) increasing research skills and b) increasing research communications measured as manuscript submissions, presentations, and publications. This natural experiment will generate new understanding into efficacy of how bystander programs work. This natural experiment will also provide the VAW research community an opportunity to increase our skill-sets and share our experiences with and help grow the next generation of VAW prevention researchers.
This is a study to determine whether a theoretically-driven web-based 3-hour intervention designed for male college students called RealConsent is effective in increasing prosocial intervening behaviors and in preventing sexual violence perpetration. Sexual violence programs for this population have been implemented for decades in the United States, but a program that is web-based and incorporates the bystander education model has never been implemented or tested. In this study, male college students will be recruited online, enrolled and randomly assigned to RealConsent or to a comparison condition. Prior to the intervention, investigators will ask questions about their intervening and sexually coercive behaviors and other theoretical and empirical factors related to the study outcomes. Investigators will survey the young men again at post-intervention, and at 6-months follow-up to determine whether young men in the RealConsent program intervened more often and engaged in less sexual violence compared to young men in the comparison condition. The main hypotheses are: (1) college men in the RealConsent program will report more instances of prosocial intervening; and (2) college men in the RealConsent program will report less sexual violence against women.
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).
The purpose of this project is to develop and evaluate an online mentoring and skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18, the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults (who are also mentors). TGMY will be paired with a TGM adult mentor, based on their shared interests. Mentors and mentees will participate together in each session along with other mentors and mentees. Mentors will direct activities and discussion to promote TGMY social-emotional skills. The TCP sessions will include one-on-one mentor-mentee break-out sessions.
The overall goal of the 5-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Projects (SMFP) READY to Stand (RTS) curriculum with an eye toward widespread dissemination to other U.S. communities, if deemed effective.
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
Communication and Recovery Enhancement (CARE) is a 2-session early intervention for survivors of recent sexual assault and their supporters that aims to improve supporters' ability to respond effectively. The goal of this pilot trial is to understand the acceptability and preliminary efficacy of two versions of CARE: a version in which survivors and supporters attend both sessions together (dyadic CARE) and a version in which supporters attend sessions alone (supporter-only CARE). Survivors aged 14+ with elevated posttraumatic stress symptoms will enroll with a supporter of their choosing. Dyads will be randomized to dyadic CARE, supporter-only CARE, or waitlist control, and will complete self-report assessments at baseline, post-session-1, and follow-ups (1, 2, and 3 months post-baseline). Results will be used to inform future changes to CARE and determine whether a fully-powered randomized controlled trial is warranted.
Sexual violence (SV) is a significant public health problem particularly among 18-24 year old populations. A major risk factor for SV is alcohol use, which via its negative impact on cognitive abilities and decision-making acts as a barrier to intervening in situations at-risk for a SV. This study has two main goals: (1) to determine the effects of proximal alcohol use on young (age 21 to 25) men's prosocial bystander behavior in situations considered at-risk for SV, and (2) to determine the efficacy of an evidence-based, web-based program called RealConsent, which has been augmented to include alcohol-specific content within the context of bystander SV ("RealConsent2.0"), on men's prosocial bystander behavior. The primary study endpoint is prosocial bystander behavior and will be assessed via two modes: (1) a virtual reality (VR) environment ("B-SAVE") and (2) a validated self-report measure of bystander behavior that has been modified to include assessment of proximal alcohol use and presence of alcohol within the context.
Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP). This project will expand the existing evidence base by evaluating Sources of Strength for sexual violence outcomes in a randomized controlled trial (RCT) in twenty-four high schools.
The purpose of this project is to implement a pilot study to investigate the feasibility and preliminary efficacy of a peer support specialist delivered violence prevention program for women in substance use treatment. The program entails a posttraumatic stress disorder (PTSD) screening, resource referral, and two session interpersonal violence prevention protocol for 60 participants. In this single arm trial, women are recruited from three substance use treatment facilities. Participants complete baseline, post-intervention, one-month, and three-month follow-up assessments. Self-report surveys assess trauma exposure, knowledge and behaviors related to interpersonal violence, and intervention engagement.
Given the public health and social relevance of sexual aggression and the gap in the extant literature regarding state anger, emotion regulation, alcohol, and sexual aggression, the present study will contribute to our understanding of emotion regulation's role in sexual aggression perpetration. The proposed 2-year research plan will examine the effects of alcohol intoxication, state anger, and emotion regulation on men's sexual aggression intentions. This study will recruit non-monogamous, men (individuals who identify their gender as male and whose biological sex is male) who have sex with women, ages 21-35. While more research on female perpetrators is needed, the proposed study will exclusively recruit males for the following reasons: 1) the scientific literature indicating the majority of sexually aggressive acts are perpetrated by men; and 2) the current sexual aggression analog has not been piloted with female participants and would require preliminary experiments to determine its appropriateness. The study will utilize a 2x2 design in which participants are randomized to beverage condition \[alcohol (target BAC= .08gm%) or control (no alcohol control)\] and an emotion induction (anger induction or control). The outcomes will be assessed using a sexual aggression analog which participants will complete on the descending limb of alcohol intoxication and indicate the likelihood that they would engage in various sexually aggressive acts. The study also includes self-report measurements of state anger and emotion regulation to explore emotion regulation as a moderator in the associations among alcohol intoxication, state anger, and sexual aggression intentions.
The present project integrates previous research on factors associated with alcohol-involved sexual assault, with research on how intoxication alters attention and social perceptions in ways that increase the risk of sexual aggression and victimization. Specifically, this project examines whether alcohol intoxication on the part of a male perpetrator impairs attentional capacity and leads to a narrowing of the perceptual field causing a dehumanizing perspective of women as sexual objects for men's pleasure rather than individuals with thoughts and feelings, thereby increasing the propensity for sexual aggression. The present research also examines whether women's responses to this sexual objectification from men interfere with risk perception in sexual situations, particularly when women are drinking, increasing the likelihood of sexual victimization.