Treatment Trials

29 Clinical Trials for Various Conditions

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RECRUITING
Youth Participatory Action Research to Prevent Community Violence Among Black Youth
Description

This behavioral intervention study aims to evaluate the effectiveness of Youth Empowered Advocating for Health (YEAH) on youth prosocial behavior and aggressive behavior and assess racial identity and future orientation as mediators of prevention effects.

RECRUITING
Community Resiliency Collective Efficacy Intervention
Description

This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of a community-centered intervention that promotes thriving and resiliency to reduce community violence.

RECRUITING
Recovery Legal Care Clinical Trial
Description

Hospital-Based Violence Intervention Programs (HVIPs) affiliated with trauma centers in the US often focus on individual behavior modification for reduction in re-victimization. There is a lack of reproducible evidence that has demonstrated effectiveness, given the exclusion of addressing inequities in the Social and Structural Determinants of Health (SSDOH), often the root causes of violent injury and preventable homicide. The study investigators created a Medical Legal Partnership (MLP) to partner with an existing HVIP. This novel program offers beside legal assistance to address the SSDOH. The purpose of this study is to evaluate the effectiveness of the HVIP-MLP program in improving violence-related outcomes, legal needs, health-related quality of life, PTSD symptoms, and perceived stress.

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.

COMPLETED
National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
Description

Trauma-informed treatment will improve emotional regulation and behavior.

COMPLETED
Community-Based Violence Prevention for High-Risk Youth
Description

Study Aims: 1) Assess the receptiveness of youth and families to injury prevention interventions initiated from the emergency department; 2) In a sample of high risk youth presenting to the ED with interpersonal assault injuries, determine the effectiveness of a home-based family intervention with community linkage compared to a control group.

COMPLETED
Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2
Description

Phase 1.2: Open Trial N=15 women survivors of interpersonal violence will be enrolled into a single-arm pilot trial to test the adapted integrative hatha yoga and mindful self-compassion program.

Conditions
RECRUITING
Creating Peace: Community-based Youth Violence Prevention to Address Racism and Discrimination
Description

This cluster-randomized community-partnered study will examine the effectiveness of a trauma-sensitive, gender transformative youth violence prevention program called Creating Peace that integrates racism and discrimination prevention with youth ages 14-19.

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.

ENROLLING_BY_INVITATION
Preventing Youth Violence Through Building Equitable Communities
Description

Interpersonal or community violence is a long-standing health disparity that disproportionately affects African American youth, and suicide is disproportionately increasing among African American youth. This project evaluates the impact of a multisystemic prevention program designed to reduce health disparities in violence by promoting equity in African American youths' experiences in education systems. This intervention has the potential to reduce morbidity and mortality among African American youth, promote overall quality of life, and reduce the societal costs associated with both interpersonal violence and suicidality.

TERMINATED
Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative
Description

The purpose of this research study is to test if a hospital-based violence prevention strategy with a community-level initiative is effective for cross-cutting violence prevention in violently injured youth.

RECRUITING
Changing Youth Narratives on Firearm Violence ("Run It Up") Intervention
Description

The Run It Up project is an experimental, theory-driven effort to address a specific connection between structural factors, youth identity development, and violence, where structural factors in some communities may limit adolescent beliefs about potential life-trajectories ("possible selves"), and foreground potential trajectories that include violence as integral. The intervention seeks to counter that dynamic by: 1) identifying alternative, non-violent identity trajectories that have attributes meaningful for youth and actualizing those trajectories through a community support structure; and 2) developing and disseminating multiple media products featuring narratives about these alternative trajectories. The goal is to change the calculation of possible selves for adolescents in the identity development stage through the introduction, and actualization, of desirable, tangible trajectories that do not involve violence or pro-violence norms, resulting in a reduction of youth involvement in firearm violence. The intervention and research is being conducted through a partnership between the George Washington University Milken Institute School of Public Health and the Washington, DC community of Washington Highlands, and is funded through a grant from the National Institute on Minority Health and Health Disparities (NIMHD). In the first phase, formative research was completed to identify attributes and alternative non-violent trajectories, determine intervention elements, develop an intervention "brand" representing the attributes, develop a baseline-follow-up survey measuring theoretical mediators/moderators, outcomes, and other potential influencing factors, and identify community data to be used for a time-series analysis. Now in the second phase, the baseline data from a sample of community youth and parents/guardians are currently being collected prior to implementing the intervention. Evaluation is a two group, quasi-experimental community cohort design using survey and community-level data.

NOT_YET_RECRUITING
Mississippi Violence Injury Prevention (VIP) Program
Description

This clinical trial is designed to evaluate the effectiveness of three interventions aimed at preventing violence and supporting those affected by it. Over next three years, the impact of these interventions on key areas will be measured, including the incidence of firearm injuries, the recovery of victims, the occurrence of retaliation and re-injury, and health economics. The interventions are developed based on data collected from a comprehensive needs assessment, community summit, retrospective medical chart reviews, and focus group sessions. The defined interventions are as follows: Intervention A - Integration of an existing community-based intervention program with Hospital services intervention B - Unrestricted Cash Assistance Intervention C - Mobile Community Support Services Additionally, the investigators will implement a detailed violence-focused survey for firearm survivors at the time of study enrollment. Follow-up is planned at 3,6 and 12 months. The results of this trial (including analyses of firearm injury rates, recovery outcomes, retaliation/re-injury occurrences, and economic data) will be shared with the affected communities and stakeholders to promote ongoing improvement and support.

Conditions
RECRUITING
Community Park-Based Programs for Health Promotion: the Fit2Lead Prospective Cohort Study
Description

The Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth participant mental health, resilience, physical fitness, and violence prevention outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Lead prospective cohort study run by Miami-Dade County Parks and Recreation.

NOT_YET_RECRUITING
Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area
Description

The purpose of this study is to evaluate the effectiveness of Houston-HVIP in reducing the occurrence of repeat firearm violence among adults receiving care at Memorial Hermann Hospital in Houston,to determine the impact of the community-engaged Houston-HVIP program on violent victimization and mental and behavioral health, to assess the impact of the Houston-HVIP program on reducing racial and ethnic disparities among individuals impacted by firearm violence injury, to determine the impact of the community-engaged Houston-HVIP program on physical and behavioral health during the 12-month follow-up period and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists.

Conditions
RECRUITING
MISC-IPV: A Community-Based Intervention for Children Traumatized by Intimate Partner Violence
Description

This study adapts and evaluates preliminary outcomes of the Mediational Intervention for Sensitizing Caregivers (MISC) for women and children of color who have survived domestic violence.

ENROLLING_BY_INVITATION
A Randomized Controlled Trial of ACT-P Versus T4C for Community Reentry
Description

The purpose of the proposed study is to determine the efficacy of Acceptance and Commitment Therapy for prisons (ACT-P) and Thinking for a Change (T4C) as reentry programs in a randomized controlled trial (RCT).

RECRUITING
MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence
Description

The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed study will enroll pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 6 months after enrollment.

COMPLETED
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
Description

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.

COMPLETED
CRISOL Contigo: a Multi-level Intervention to Reduce the Disproportionate Toll of COVID-19 Among Latino Communities in Philadelphia.
Description

Latinos have been one of the racial/ethnic groups most impacted by the COVID-19 pandemic, and evidence of effective strategies to curb the pandemic, reduce disparities, and mitigate its impact is lacking and very urgent. The goal of this competitive revision is to expand an ongoing academic-community partnership to adapt, implement, and evaluate a multi-level intervention to mitigate the multi-dimensional toll of COVID19 among Latino immigrant communities in Philadelphia.

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
ePREP for Community Couples
Description

The purpose of the present study is to examine the impact of ePREP when it is administered to couples. More specifically, investigators will test whether--compared to placebo controls--participants who receive ePREP will experience better outcomes for relationship relevant variables.

ACTIVE_NOT_RECRUITING
The Community Youth Development Study: A Test of Communities That Care
Description

The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.

COMPLETED
Community Based Youth Injury Prevention Program
Description

America's greatest resource is its youth, but that resource is increasingly threatened by violence. Recommendations for violence prevention have highlighted the need to focus on youth and to explore targeted interventions Nowhere is the need greater than in our nation's capital where the intentional injury fatality rate for youth age 14-19 is higher than any of the 50 states. This study builds on the CDC-supported project Adolescent Violence: A Community-Based Strategy which instituted citywide surveillance on injuries, conducted by researchers at the Children's National Medical Center. In this study, the same researchers will extend that work by testing an individualized intervention to reduce violent behavior among a sample of assault-injured youth, age 9-15, who present at the Emergency department (ED). 196 youths and their families will be included in this randomized trial, with 98 families assigned to the individualized intervention condition and 98 families assigned to the control condition. Families will be followed for 18 months. To address issues of attrition over the 18 months that the study follows, approximately twice as many families, or 400 families, will be recruited to participate in the study.

COMPLETED
Reducing HIV & Domestic Violence Risk in Women Offenders
Description

The long-term goal of this work is to reduce the prevalence of HIV and domestic violence among women at risk by encouraging self-protective behaviors. To obtain this goal, Multnomah County Health Department and Oregon Department of Human Services have conducted a randomized trial of an intervention to prevent HIV and domestic violence among women who have recent criminal justice involvement and who are at risk for HIV infection. Women enrolled in the study were randomly assigned to one of three study conditions: * Group 1: these women received information on local resources addressing HIV prevention, domestic violence, and life stability issues; they did not receive any counseling sessions as part of the study itself. * Group 2: these women received up to ten supportive counseling sessions based on the techniques of motivational interviewing. These sessions aimed to reduce HIV risk and to improve life stability. * Group 3: these women received up to ten supportive counseling sessions based on motivational interviewing. These sessions aimed to reduce risk for HIV and domestic violence and to improve life stability. The primary hypotheses of this study were: * 1. Supportive counseling (motivational interviewing) addressing HIV prevention and increased life stability will lead to reductions of HIV risk behavior among women enrolled in the study. * 2. Supportive counseling (motivational interviewing) addressing domestic violence prevention, HIV prevention, and increased life stability, will bring about reductions in experiences of domestic violence and a reduction of HIV risk among these women. * 3. The supportive counseling received in this study will enhance these women's self-efficacy, self-esteem, and psychological well-being. Women in all three experimental groups were interviewed at the beginning of the study and again after 4, 7, and 10 months. These assessment interviews asked questions about: HIV risk; experiences of domestic violence; and life stability issues such as education, employment, and housing; and included biological testing for HIV and sexually transmitted diseases. Women in Group 2 and Group 3 participated in up to 10 sessions of supportive counseling (motivational interviewing) between the time of enrollment and the 4-month interviews.

COMPLETED
Youth Empowerment Solutions for Peaceful Communities
Description

This project is an evaluation of an intervention to involve youth in creating community change for peace promotion and violence prevention. The intervention, Youth Empowerment Solutions for Peaceful Communities (YES), includes three components: youth empowerment activities, neighborhood organization development, and community development projects that involve youth and organizations working together. Hypothesis 1: Efforts to engage youth in the community change process will enhance their attachment to their community, reduce their problem behaviors, and begin to change norms among their peers about community violence and interpersonal problem solving. Hypothesis 2: Efforts to make community-based organizations more youth-friendly and engaging will assist them to be more effective in reaching their community enhancement goals and will expand youth involvement in their mission. Hypothesis 3: Efforts to create more health-enhancing land use (e.g., beautification, community gardens, parks development) will improve social organization (e.g., social capital, social cohesion, and social support), and reduce the level of violent incidents and crime in the community.

COMPLETED
Youth Empowerment Solutions for Positive Youth Development
Description

The Youth Empowerment Solutions for Positive Youth Development (YES) Study , is a randomized controlled trial that compares youth in standard after school programs offering activity choice (e.g. sports, academic enrichment, arts) to youth assigned to an after school program that includes training in community development, formation of intergenerational partnerships and experience conducting community improvement projects. The study aims are to: 1) implement and evaluate an empirically developed intervention for empowering youth (YES) using a randomized controlled trial design in a high risk urban and suburban sample; 2) test a conceptual model that posits a causal relationship from youth empowerment processes to positive developmental outcomes; and 3) follow youth over time to assess sustainability of gains in healthy development. Developmental outcomes will be assessed at baseline, curriculum completion and at three and nine months post-intervention. This study will be referred to as the Genesee County Afterschool Study (GCAS) in recruitment, consents, assents and promotional materials. The study compares different types of after school programs, and we will be randomly assigning students into two groups, 1) the "regular" 21st Century Afterschool programs and 2) the "regular" 21st Century Afterschool programs with the YES supplement. We do not want to bias desirability of the random groups by naming one of the groups to be tested in the study name. Therefore, in documents we will refer to the study as the "Genesee County Afterschool Study (GCAS)." Study hypotheses: 1. Youth in the YES intervention arm will demonstrate increased intrapersonal, interactional, and behavioral empowerment than youth in the comparison group arm. 2. Youth in the YES intervention arm will demonstrate higher scores on the positive developmental outcome variables, and lower scores on the negative developmental outcome variables, than youth in the comparison group arm. 3. Behavioral empowerment will partially mediate the relations between intrapersonal and interactional empowerment and youth developmental outcomes, such that youth with greater intrapersonal and interactional empowerment skills will demonstrate increased behavioral empowerment, which in turn will result in higher scores on positive developmental outcome variables, and lower scores on negative developmental outcome variables.

COMPLETED
Randomized Trial of the Positive Action Program in Chicago Schools and Extension to Grade 8
Description

This project focuses on social and character development of elementary and middle school-aged children and responds to an urgent national need that schools improve their capacity to address a range of student outcomes, including social skills, character, behavior, academic achievement and health outcomes. This study is a school-based randomized trial to evaluate the Positive Action program. The Positive Action program was designed to promote social and character development and improve behavior and school performance.

COMPLETED
Preventing Anxiety Disorders in Urban Youth
Description

This study will determine the effectiveness of a cognitive-behavioral group therapy program in preventing anxiety disorders in at-risk children exposed to community violence.