17 Clinical Trials for Various Conditions
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.
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.
The purpose of the proposed work is to harness cutting-edge machine learning methods to optimize prediction of future firearm violence in youth ages 18-24 so that prevention resources can be allocated efficiently.
The goal of the study is to understand if hospital-based violence interventions are effective for reducing youth violence among violently injured youth. This study will allow researchers to learn more about the intervention's effectiveness. The researchers also want to understand if the violence intervention impacts other behaviors, such as firearm use, drug use, aggression, risky behaviors, and rates of violent re-injury.
The preclinical curriculum related to firearm violence and safety counseling at the UCLA David Geffen School of Medicine (DGSOM) has been expanded for the Class of 2027, informed by the results and conclusions of an initial study of firearm safety counseling by medical students (ClinicalTrials.gov ID: NCT05242627), which was conducted by the present study team. The 1-hour firearm safety counseling training session used in that study will be taught again to first-year medical students in the Class of 2027, but training will be augmented with additional instruction; the Class will receive additional comprehensive instruction on suicide risk assessment and will participate in small group breakout sessions, to facilitate the opportunity for students to discuss issues related to firearm violence as a public health issue and to practice firearm safety counseling with standardized patient actors (SPs). Assessment of access to firearms and firearm safety counseling will be added as a standard component of the Social History that students are taught to obtain from patients during clinical examinations. The goal of the expanded training is to increase the prevalence of medical student counseling when they are conducting a history and physical examination in a simulated patient encounter with an SP 6 months after the initial training session, when compared to results from the initial study. The scenario provided to the SP will be identical to that used in the initial study and is a situation in which firearm safety counseling is warranted. Students will participate in a survey to ascertain their knowledge of firearm violence and their attitudes about physician counseling about firearm safety, prior to formal instruction. Informed consent will be obtained from students to use their responses in educational research. Following the didactic and small group sessions, students will be asked to complete a post-training survey that is similar to the original survey, as a means of assessing knowledge gained and any change in attitudes about physician counseling. The simulated patient encounter will occur approximately 6 months later, after which students will complete another survey to determine retention of knowledge and their experience during the simulated patient encounter. Students will not be told before the encounter that they will be evaluated regarding firearm safety counseling. The SP will identify which students did and did not raise the issue of firearm safety. Videos recorded of each students' sessions (routinely obtained for grading purposes) will be viewed by investigators for those students who provide informed consent, to determine the quality of counseling, if it was conducted. Results from this follow-up study will be compared to the results of the initial study as a historical control, to determine whether augmentation of firearm safety counseling training above a 1-hour didactic session increases firearm safety counseling by medical students in a clinical setting and whether it improves retention of knowledge about firearm violence.
The present study is evaluating the efficacy of a behavioral intervention to reduce risky firearm carriage among a high risk sample of youth reporting recent firearm carriage and ownership of a smartphone.
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.
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.
This study is a quasi-experimental design, specifically a non-randomized controlled trial (NCT) designed to test the effects of gun violence reduction intervention including MI for youth ages 16-24 years old who present to the Emergency Department or ICU Spirit of Charity Trauma Center (SCTC) at University Medical Centers or another area hospital in New Orleans, Louisiana following a gunshot injury or stab wound. The study will utilize an enrollment strategy that involves alternating, across recruitment days, the assigned study condition. Thus, Day 1 participants would be enrolled into TAU, Day 2 participants would be enrolled in MI-case management condition, Day 3 participants would be enrolled in TAU, etc. This proposed design will minimize any confounds associated with self-selection while possibly increasing enrollment rate. Research questions include: 1. Will youth allocated to the MI prevention condition have safer firearm related behaviors and beliefs compared to the TAU control condition at 6 months post- enrollment? 2. Will youth allocated to the MI prevention condition have reduced gun violence recidivism compared to the TAU control condition at 18 months post-enrollment. 3. How do youth's social and normative environments influence their gun behaviors and attitudes? Researchers will compare intervention and TAU arms to see if there are any differences in outcome measures. Participants will: 1. complete study eligibility assessment, be assigned to one of two conditions depending on the date of assessment, consent, and enroll in the Emergency Department (ED) or inpatient unit of hospital by a study team member, 2. participate in one of two conditions: MI administered by a licensed clinical social worker, or treatment as usual control group (TAU) administered by a study team member (n=170 per condition) 3. complete three surveys (baseline, 3-month, and 6-month) conducted by a study team member 4. 18-month post examination of participant hospital records 5. have the option to complete a 1-1.5 hour interview, 1-3 months after the 6-month survey is completed (n=50)
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.
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?
Aim 2: Evaluate the preliminary efficacy of the SAFR intervention using a randomized controlled trial. An additional 100 practicing social workers (excluding participants from Aim 1) will be recruited, with n = 50 allocated to each arm of the study utilizing block randomization. Participants in the control arm will receive invitations to all surveys but not to the SAFR intervention itself. We will utilize the validated measures from Aim 1 to assess changes on study variables. Results will be analyzed using either mixed linear models or generalized estimating equations as appropriate. Analyses will be performed with a focus on estimation of parameters for use in the planning of a subsequent comparative trial designed to fully assess intervention efficacy with a national sample. Supportive analyses that adjust for participant covariates will also be considered. We will also ask participants for feedback on the intervention and will track indicators of feasibility and acceptability (recruitment rates, completion of intervention and measurement tools).
The overall objective of this study is to implement and test a strengths-based, community-driven intervention to reduce gun violence by (1) improving housing stability through providing financial assistance coupled with comprehensive financial education for the re-entry population as well as their family members, and (2) fostering greater support for mental health by training a trusted network of community members in trauma-informed counseling.
Modifiable risk factors for youth firearm injury and death include unsafe storage of a firearm in the home, prior victimization/aggression, substance use, and depressive symptoms, yet there are few partnerships with firearm owners and firearm safety training programs to implement effective, non-policy-based preventive interventions for youth firearm injury. This study will conduct a hybrid effectiveness-implementation trial to evaluate the effectiveness of Guardians 4 Health, a bystander intervention designed to promote changes in firearm injury prevention norms, attitudes, intentions, and behaviors among a sample up to 60 4-H Shooting Sports Club communities comprising both adults and youth. This project is designed to build the evidence base for interventions that promote safe behaviors related to youth firearm use and injury prevention and advance firearm injury prevention science by supporting a synergistic partnership between well-established firearm injury, suicide, and violence prevention researchers and the national 4-H Shooting Sports community.
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.
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.
The study's goal is to perform an evaluation of a Southeastern hospital violence intervention program (HVIP) that includes comprehensive patient outcomes, perceived benefits and opportunities for improvement of an HVIP from the perspectives of multiple stakeholders including patients, family members and healthcare providers.