Treatment Trials

317 Clinical Trials for Various Conditions

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RECRUITING
A Virtual Reality Brief Violence Intervention: Preventing Gun Violence Among Violently Injured Adults
Description

The overall aim of the proposed project is to develop and evaluate the effectiveness of Brief Violence Intervention-Virtual Reality (BVI-VR) for reducing firearm-related violence, re-injury, and mortality among victims of violence. Outcome measures of firearm-related violence will come from multiple sources, including criminal background checks, hospital data, state-level data, semi-structured clinical assessments, and self-report assessments. In addition, the study aims to understand the impact of BVI-VR on psychosocial mediators resulting in a reduction of firearm-related violence. This will include self-report surveys, neurocognitive assessments, and clinical assessments. The economic efficiency of BVI-VR as a firearm-related violence intervention will also evaluated. To achieve these aims, a randomized control trial (RCT) in a large sample of violently injured adults (18+ years) from VCU Health will be conducted.

Conditions
ENROLLING_BY_INVITATION
Evaluation of Violence Prevention Strategies to Prevent and Reduce Community Levels of Youth Violence
Description

The goal of this research study is to implement and evaluate a comprehensive community-level approach, Healthy Communities for Youth, that includes both a selective hospital-based prevention strategy, Emerging Leaders, and universal prevention strategies that increase Positive Youth Development opportunities through participatory action research, stakeholder education, community mobilization, and an overall focus on increasing community capacity for prevention. Key project aims are to evaluate the impact of Healthy Communities for Youth on community rates of youth violence using surveillance data and evaluate the impact of each violence prevention strategy on proximal outcomes including their impact on risk factors and protective processes related to multiple forms of youth violence.

RECRUITING
Addressing Root Causes for Gun Violence Prevention (ARC-GVP)
Description

The goal of this study is to help build the evidence base for a locally-relevant youth firearm violence prevention program in Washington D.C., a city experiencing disparities in youth firearm violence outcomes. The main question it aims to answer is: How is youth participation in the summer youth employment program, the True Reasons I Grabbed the Gun Evolved from Risk (The T.R.I.G.G.E.R Project), which is designed to address root causes of gun violence, associated with individual youth behavioral outcomes, including pro-social involvement, aggression, and firearm-related attitudes and behaviors?

ENROLLING_BY_INVITATION
Perceptions and Prevalence of Workplace Violence in Healthcare
Description

Workplace violence includes physical and verbal aggression as well as threatening behavior. All types of workplace violence incidents in health care are often under-reported, especially if there is no lasting physical injury.

Conditions
RECRUITING
Nationwide Study of Firearm Violence Prevention Tactics and Policies in K-12 Schools
Description

This observational study will collect data and address the following three specific aims. Aim 1: To determine if the total number and specific types of safety tactics and policies are associated with the occurrence of intentional shootings in a sample of 650+ K-12 public schools. Primary Aim 1 hypothesis -- The total number of cumulative safety tactics and policies will be significantly associated with intentional school shootings. Secondary Aim 1 hypothesis -- When organized into three domains (physical target hardening, emergency response and technologies, and school security), the total number of safety tactics and policies within each domain will be significantly associated with intentional school shootings. Aim 2: To determine if the total number and specific types of safety tactics and policies are associated with suspension and expulsion rates in a sample of 650+ K-12 public schools. Primary Aim 2 hypothesis -- The total number of cumulative safety tactics and policies will be significantly associated with student discipline outcomes. Secondary Aim 2 hypothesis -- When organized into three domains (physical target hardening, emergency response and technologies, and school security), the total number of safety tactics and policies within each domain will be significantly associated with student discipline outcomes. Aim 3: To identify if urban/non-urban, economic, and racial disparities prior to and following the onset of the COVID-19 pandemic exist in effect modification analyses of the relationships between the implementation of safety tactics and policies, suspensions and expulsions, and intentional shootings in K-12 public schools. Aim 3 Hypothesis: Significant urban/non-urban, economic, and racial disparities prior to and following the onset of the COVID-19 pandemic will exist in effect modification analyses of the relationships between the implementation of safety tactics and policies, suspensions and expulsions, and intentional shootings in K-12 public schools.

Conditions
WITHDRAWN
Workplace Violence, Hostility & Safety
Description

Workplace violence has been documented as a global, epidemic healthcare- related problem. The American Nurses Association (ANA) describes customer/client violence as an assault from a member of the public with whom the nurse interacts during the course of their regular duties. According to the ANA's website, types of violence that contribute to unsafe work environments are varying. However the customer/client violence type is prevalently experienced in healthcare, and 1 in 4 nurses are abused and experience workplace violence.

Conditions
RECRUITING
Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement
Description

This study will use a randomized control trial (RCT) design to administer two versions of a multisession remote behavioral intervention for youth seeking Emergency Department care for a violent injury with the goal to reduce their violence involvement and associated negative behaviors and consequences. The study examines two versions of the remote therapy intervention - a standard RTI (S-RTI) and an Artificial Intelligence RTI (AI-RTI). The application of a just-in-time adaptive strategy to address youth violence is an important and novel direction for this research, particularly given the need to understand best practices for delivering behavioral interventions among lower-income populations.

RECRUITING
Preventing Retaliatory Gun Violence in Violently Injured Adults
Description

The purpose of this research study is to find out if a hospital-based violence intervention (Bridging the Gap) is effective for reducing violence. The researchers think that adults who receive Bridging the Gap will see greater improvements than those who do not receive the intervention. This study will allow them to learn more about the intervention's effectiveness. The study will also help them understand if the violence intervention affects other behaviors, such as firearm use, drug use, aggression, risky behaviors, and rates of violent re-injury.

Conditions
COMPLETED
An Outcome Evaluation of the Project CHANGE-MS Violence Intervention Program
Description

This is a prospective randomized control trial design to evaluate the effectiveness of a hospital based violence intervention program. Participants will be randomized into a "treatment as usual" group who will receive written referrals for services and an "enhanced services" group who will receive intensive case management over a one year period. Primary outcome will be rate of violent reinjury after enrollment. Follow-up will be for one year.

ACTIVE_NOT_RECRUITING
Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents
Description

The purpose of this investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.

COMPLETED
A Multi-level Approach to Violence Prevention Among African American Adolescents
Description

The overall goal of this study is to advance the science of youth violence prevention and the social determinants of health by using a community-driven approach to implement a comprehensive intervention. The objective of the proposed project is to assess the feasibility, acceptability, and preliminary efficacy of an innovative, multi-level intervention that promotes adolescent protective factors and reduces risk behaviors among African American youth residing in Birmingham. Alabama.

COMPLETED
Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools
Description

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.

Conditions
COMPLETED
Exposure to Gun Violence in Video Games Increases Interest in Real Guns
Description

More American children die by accidental gun use than children in other developed countries. One factor that can influence children's interest in guns is exposure to media containing guns. The objective of this study is to test whether children who play a video game containing guns will handle a real gun longer, will pull the trigger more times, and pull the trigger while pointing the gun at themselves or another than children who see the same movie without guns.

COMPLETED
Translation of an Intervention for Violence Among Adolescents in Emergency Departments
Description

The translation study aims to refine and package intervention and training materials essential to translating an efficacious Emergency Department (ED) based Brief Intervention (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist remotely. The study will take place in two phases. During the Effectiveness phase, we will determine the effectiveness of the interventions \[on-site therapist delivered BI + text messages (n=133); remote therapy delivered BI + text messages (n=133)\], as compared to a usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored text messages will be delivered daily for the first month post-discharge, and three times per week in the second month post-discharge to the BI groups. During the Implementation phase, components of the RE-AIM model will be assessed over a 4-month period.

Conditions
COMPLETED
School Based Program to Prevent Teen Dating Violence
Description

This study is a school-based cluster randomized trial of the 7th grade version of Fourth R, a promising teen dating violence prevention program, with 24 ethnically diverse middle schools (12 intervention schools, 12 control schools) in one of the nation's largest school districts. Students (N = 3,375) will be the unit of analysis and studied prospectively (baseline, \[post-intervention\], and annually for 3 years) to determine the impact of the program by comparing students in intervention schools with those in control schools.

Conditions
COMPLETED
Dating Violence Prevention for Juvenile Justice Girls
Description

Girls in the juvenile justice system are at high risk for dating violence exposure as well as co-occurring problems with delinquency and sexual risk taking. Despite the multitude of negative outcomes associated with dating violence, no evidence-based preventive interventions exist for juvenile justice girls. This study will advance scientific knowledge by testing the efficacy of a promising, skills-based intervention (Date SMART) on reducing dating violence, delinquency and sexual risk outcomes for a broad range of court-involved, non-incarcerated girls.

Conditions
COMPLETED
Using Media to Shift Social Norms of Violence Among Youth
Description

The project will utilize a quasi-experimental design to examine the effectiveness of a community-level, three-year social norming campaign aimed at changing norms of violence among youth 10-24, with West Louisville (WL) as the intervention community and East Nashville, Tennessee as the control community. The project will address the following research questions (RQs): RQ1: To what extent is a social norming campaign effective in changing the descriptive and injunctive norms of violence among youth in WL? RQ2: To what extent are the descriptive and injunctive norms of violence among youth in WL related to violent behavior (by type)? RQ3: To what extent is a social norming campaign effective in reducing population rates of youth violence in WL? RQ4: Which forms of media are most effective in reaching youth of different ages with campaign messages? RQ5: How is community readiness related to implementation of a community-level social norming campaign? RQ6: How is community capacity related to implementation of a community-level social norming campaign? RQ7: How does community capacity to address youth violence change over time with the implementation of a community-level social norming campaign? RQ8: To what extent is a social norming campaign cost-effective in reducing incidents of serious violence among youth?

Conditions
COMPLETED
Trauma Services Intervention to Prevent Violence
Description

Primary outcome: Research participants and their network contacts will be followed over 6 months to assess whether a social work case management protocol results in reduction of trauma services recidivism and criminal violence arrests.

COMPLETED
Engendering Healthy Masculinities to Prevent Sexual Violence
Description

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.

COMPLETED
Trial of a Middle School Coach Gender Violence Prevention Program
Description

This cluster-randomized school-based study will examine the effectiveness of a program for the primary prevention of perpetration of teen dating violence and sexual violence among middle school male athletes. Engaging men and boys in preventing violence against women and girls is recognized by major global health organizations as a critical public health strategy. "Coaching Boys into Men" is a theory- and evidence based program intended to alter gender norms that foster teen dating violence/sexual violence perpetration, promote bystander intervention, and reduce teen dating violence/sexual violence perpetration. Coaches receive a 60-minute training and biweekly check-in from a violence prevention advocate to administer the intervention to their athletes via 12 mini-lessons conducted weekly throughout a sport season. In a randomized trial of program effectiveness among high school athletes (Centers for Disease Control and Prevention CE001561-01, PI Miller), male athletes receiving the program demonstrated increased positive bystander intervention behaviors and less verbal abuse perpetration compared to controls. This project seeks to test the effectiveness of this program with younger male athletes in grades 6-8.The innovations are three-fold: (1) testing the efficacy of a novel teen dating violence/sexual violence prevention program for middle school male athletes; (2) training athletic coaches in Teen Dating Violence/Sexual Violence prevention thus implementing primary prevention that does not rely on teachers or classroom time; and (3) integrating the goal of changing gender norms with the technique of a bystander intervention approach to reduce teen dating violence/sexual violence prevention. The experimental design involves a 2-armed cluster randomized- controlled trial in 41 middle schools (38 clusters) in Pennsylvania. Schools will be randomly assigned to either intervention or control (standard coaching) condition. Coaches in intervention schools will receive Coaching Boys into Men training. Baseline surveys will be collected for all intervention and control site athletes entering grades 6-8 at the start of each sports seasons across Year 1 (Time 1; N= 973 athletes). Follow up surveys will be collected at the end of each sports season (Time 2). All participating athletes will be re-surveyed 12 months after baseline (Time 3).

Conditions
UNKNOWN
Lithium Water in Gun Violence Prevention
Description

The word lithium frequently conjures images of catatonic psychiatric patients and side effects so severe that premature death is commonplace. But naturally occurring lithium is a far cry from pharmaceutical grades. Found in the soil, water and certain foods, it is an essential mineral for maintaining physical and mental health. When exposure is low, suicide rates, mental illness and violent crime increase

COMPLETED
Enhanced Nurse Home Visitation to Prevent Intimate Partner Violence
Description

An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This randomized trial of an intervention to assess and prevent intimate partner violence during pregnancy and the post-partum builds upon the David Olds model of nurse home visitation (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be effective in multiple settings in preventing child abuse and enhancing maternal and child health and psychosocial outcomes. However, prior research has shown that the NFP intervention is not as effective in homes where there is intimate partner violence (IPV). Although the NFP by itself has reduced IPV in one setting, it has not in another. The proposed study will test the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice or empowerment model whereby women can choose among interventions related to her goal for her current intimate relationship. If IPV or emotional abuse or controlling behaviors are assessed, the intervention is based on two interventions shown to be effective in assessing for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker brochure driven intervention). For women desiring to enhance marital quality, the Markman and Stanley PREP model that has been shown to enhance relationship quality will be offered. The PREP model also has some preliminary evidence of preventing IPV. For women with other risk factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child abuse, substance abuse), community resource linkage (beyond referral) strategies as with the NFP model will be used to obtain community resources to address these risk factors. 250 women referred to the Multnomah County Health Department will be randomized to the experimental (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule during pregnancy and until the infant is 24 months old. The intervention will concentrate on the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome measurement (CTS2, WEB, TPMI, depression - Edinborough, \& parenting stress), will occur at 3 months before delivery, 9 months \& 21 months post-partum with multivariate MANOVA, SEM and growth curve analyses.

COMPLETED
A Multi-Center Randomized Controlled Trial of Mentoring to Prevent Youth Violence
Description

The purpose of this study is to test whether a violence prevention curriculum delivered by Big Brothers and Big Sisters staff and mentors can reduce violence involvement for assault-injured youth.

Conditions
COMPLETED
The Effect of Primary Care Interventions on Children's Media Viewing Habits and Exposure to Violence
Description

The American Academy of Pediatrics recommends that parents receive anticipatory guidance about violence prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is: Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids brochure, entitled, "Pulling the Plug on TV Violence", help parents develop plans to decreases their children's exposure to violence in the media (e.g. less media time, no TV in the bedroom)?

Conditions
COMPLETED
Preventing Violence Among Veterans in Substance Use Disorder Treatment
Description

The purpose of this study is to examine the impact on both clinical (violence and substance use) outcomes and health services use (substance use disorder and mental health treatment) compared to standard SUD treatment (enhanced treatment as usual) of 1. an integrated Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) violence prevention treatment intervention delivered during the 8-week early substance use disorder treatment phase; and 2. MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period following the early treatment phase MI-CBT+CC). The study will provide important new information regarding the role and relative impact of both early treatment and continuing care interventions designed to impact substance use and violence, and whether combining such interventions yields additional benefits.

COMPLETED
Treating Violence-Prone Substance Use Disorder Patients
Description

This project is intended to help substance use disorder patients who perpetrate interpersonal violence against other adults.

COMPLETED
Developing Violence Prevention Therapy for Substance Abusers
Description

The purpose of this project is to develop and pilot test a violence prevention intervention for men and women in treatment for substance use problems.

COMPLETED
Evaluation of SAFER Latinos' Program to Prevent Youth Violence
Description

This is an evaluation of a primary prevention program to prevent youth violence by improving family cohesion, networking among families, school bonding, and access to services for Latinos in Langley Park, MD.

Conditions
COMPLETED
A School Program for Children Exposed to Violence
Description

This study will develop a program to help school children deal with violence-related trauma.

COMPLETED
An Arts-Based Initiative for the Prevention of Violence Against Women and Girls
Description

this project will evaluate a community and school based program to promote healthy relationships and prevent violence (physical, emotional and sexual dating violence) among predominately African American middle school adolescents in an urban setting (Baltimore, MD).

Conditions