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Sexual Assault clinical trials

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NCT ID: NCT05345405 Recruiting - Stress Clinical Trials

Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors

CARE
Start date: May 18, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05305235 Completed - Pain Clinical Trials

RCT for Innovating Stress-related eHealth

RISE
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

The Randomized Control Trial for Innovating Stress-related eHealth (RISE) Study tests the hypotheses that a highly promising digital therapeutic (RISE Guide) targeting anxiety sensitivity (AS) will be acceptable to women sexual assault survivors; reduce survivors' anxiety sensitivity, and, in turn, posttraumatic stress. If successful, RISE Guide could be provided at no cost to all women who present to US emergency departments for emergency care after sexual assault.

NCT ID: NCT05281874 Enrolling by invitation - Alcohol Drinking Clinical Trials

Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

+Change
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

Heavy episodic drinking and sexual assault are problematic on college campuses. This study includes a randomized controlled trial of Positive Change (+Change), an integrated alcohol and sexual assault prevention program, compared to an attention-matched control condition across two universities in reducing alcohol use, sexual assault victimization, sexual assault perpetration, and increasing sexual assault bystander intervention. This study will also test the efficacy of +Change plus Booster session, an identical version of +Change delivered 6 months after the baseline, compared to +Change alone in long-term reductions in alcohol use, sexual assault victimization, sexual assault perpetration, and increases in sexual assault bystander intervention. This research is the next step of a NIAAA-funded planning grant (R34AA025691).

NCT ID: NCT05257603 Completed - Sexual Assault Clinical Trials

Prevention of Alcohol-related Sexual Revictimization in College

RPCW
Start date: February 19, 2022
Phase: N/A
Study type: Interventional

This pilot randomized controlled trial (RCT) is designed to test a new intervention designed to reduce college women's risk for sexual revictimization (SRV). The intervention targets women with a history of sexual assault (SA) and recent hazardous drinking (HD), as these women are at highest risk for SRV. The primary goals of the intervention are to decrease women's HD, improve their ability to perceive cues that signal risk for SRV, and strengthen their behavioral skills in situations associated with an increased risk for SRV. The intervention, Revictimization Prevention for College Women (RPCW) is a multi-modal intervention that includes two on-line interactive education modules and two in-person group skills-based training sessions that focus on problem solving training and behavioral rehearsal. The pilot RCT of the RPCW intervention will include 96 college women with follow-up assessments at 3- and 6-months post intervention. Women will be randomly assigned to either the RPCW intervention or to a Health Education Control (HEC) condition. The pilot RCT will be used to establish the feasibility of recruitment, the acceptability and safety of the RPCW intervention, and provide initial efficacy data that will assist in power calculations for a Stage II efficacy trial. The investigators hypothesize that women in RPCW intervention will report fewer days of hazardous drinking and improved perception of sexual assault risk cues compared with participants in the HEC condition. In addition, women in the RPCW intervention will report increased knowledge of safe dating practices and protective behavioral (drinking) strategies compared with participants in the HEC condition. Finally, women in the RPCW intervention will report lower rates of SRV as compared with participants in the HEC condition at the 6-month post-intervention follow-up.

NCT ID: NCT05206994 Enrolling by invitation - Adolescent Behavior Clinical Trials

Evaluation of the Close to Home Program in California

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05065918 Completed - Clinical trials for Alcohol Use, Unspecified

Text Message Intervention for Alcohol Use and Sexual Violence in College Students

Start date: November 4, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04950686 Completed - Sexual Behavior Clinical Trials

Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-based Sexual and Relationship Health Promotion Program With Young Adult Community College Students

Start date: July 21, 2021
Phase: N/A
Study type: Interventional

Community college students are an underserved and at-risk population in terms of their sexual and relationship health. This is a three-arm randomized control trial to evaluate the long-term efficacy of a web-based sexual and relationship health promotion program among U.S. community college students (expected N = 2010) and explore the mechanisms underlying the program efficacy.

NCT ID: NCT04797741 Completed - Sexual Assault Clinical Trials

Adapting an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates for Online Delivery

Start date: June 14, 2021
Phase: N/A
Study type: Interventional

Sexual assault on college campuses is a prevalent public health problem, with 1 in 3 women experiencing sexual assault during her time in college. It is a major cause of injury, mental health concerns, sexually transmitted infections, and poor educational outcomes in youth and young adults. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance intervention is the only intervention that has been shown to reduce sexual assault victimization for college women in a randomized controlled trial. EAAA is a 12-hour, peer facilitator-led, in-person intervention proven to reduce attempted or completed rape victimization by over 50% among female undergraduates, with durable effects lasting more than two years. Despite its unique efficacy, uptake of EAAA has been limited, in large part because universities prefer less costly interventions that can be administered online; unfortunately, no online intervention has been proven to reduce victimization. This project seeks to adapt the existing EAAA intervention for online delivery to groups of students by live facilitators using a systematic adaptation process called ADAPT-ITT. After adapting and refining the intervention, the proposed work seeks to collect feasibility, acceptability, and efficacy-related outcome data. The project has three aims: 1. Aim 1: Following the ADAPT-ITT framework, pilot a minimally adapted internet-delivered EAAA (IDEA3) with undergraduate women (n=12), collecting data on acceptability immediately following the intervention. 2. Aim 2: Produce a fully adapted IDEA3 intervention that retains core elements of the in-person intervention crucial for efficacy, while capitalizing on unique strengths of the online modality. 3. Aim 3: Test the feasibility and acceptability of IDEA3 through a pilot trial and examine intermediary outcomes shown to be strong mediators of EAAA's effect on reducing victimization (n=64). The investigators hope this intervention may prevent as many as 50% of sexual assaults experienced by college women, comparable to the existing in-person intervention from which this online intervention is being adapted. Once the intervention has been finalized, the investigators plan to disseminate the intervention and make it widely available to institutions through the SARE Centre, a non-profit partner on the study that currently disseminates the in-person version of the intervention, EAAA.

NCT ID: NCT04724746 Completed - Clinical trials for Posttraumatic Stress Disorder

Integrated Intervention Post-Sexual Assault

Start date: February 20, 2020
Phase: N/A
Study type: Interventional

The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing SUD and PTSD symptoms among women who experienced a sexual assault within the past six weeks. The intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up.

NCT ID: NCT04691492 Completed - Sexual Assault Clinical Trials

Protecting Allies in Risky Situations

PAIRS
Start date: July 15, 2021
Phase: N/A
Study type: Interventional

The current project will provide testing of a friend-based motivational interview (FMI) designed to reduce sexual assault risk. The study will address if the intervention minimizes the impact of alcohol on helping behavior, test whether drinking reduces intervention efficacy, and examine potential iatrogenic effects of the intervention.