83 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if this intervention (Social Skills, Problem Solving, emotion Regulation, and psycho-Education on Trauma: A Trauma-Informed Peer Aggression and Teen Dating Violence Prevention Program; SPARE) can treat peer aggression and prevent teen dating violence in preteens receiving intensive mental health services. The main questions it aims to answer are: * Does receiving SPARE reduce proactive and reactive aggression at post-intervention and 3- and 9-month follow-ups? * Does receiving SPARE reduce positive attitude about TDV, prevent TDV behaviors, and improve mental health outcomes at post-intervention and 3- and 9-month follow-ups? Researchers will compare youth receiving SPARE to youth receiving treatment as usual to see if SPARE results in improved proactive and reactive aggression, TDV attitudes and behaviors, and mental health outcomes. Participants will: * Receive SPARE via group therapy incorporated into their daily programing at an intensive mental health program * Complete study questionnaires at program intake and discharge as well as at 3-month and 9-month follow-up assessments
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.
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.
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?
The purpose of this study is to determine the preliminary efficacy (via a micro-randomized trial \[MRT\] design) of augmenting Enhanced-Replicating Effective Program (E-REP) with engagement strategies to increase and sustain reach by healthcare providers (e.g., nurses, social workers) during implementation of the SafERteens program across multiple healthcare settings.
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.
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.
This study will test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to decrease adolescent boys' risk for dating violence involvement as well as attitudes supporting relationship aggression.
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.
Heavy episodic drinking and sexual assault (SA) are problematic on college campuses. This project will adapt already developed interventions targeting alcohol use and SA to a mHealth format and involve content that incorporates federal guidelines and CDC recommendations to integrate both bystander intervention and risk reduction content with new innovative personalized content for each risk group (cis-gender heterosexual men, cis-gender heterosexual women, and sexual/gender minorities). Alpha testing with key stakeholders, an open pilot trial, and a randomized pilot trial will be conducted to establish acceptability and to estimate sample size for a larger randomized controlled trial.
The purpose of this study is to compare two versions of Mental Health Enhanced Positive Behavioral Interventions and Supports in reducing aggression in middle school students.
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.
This study will develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to decrease adolescent boys' risk for dating violence involvement as well as attitudes supporting relationship aggression.
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 the study is to adapt and test an evidence-based trauma treatment program for adolescent girls with histories of child maltreatment. The study adapts the CBITS (Cognitive Behavioral Intervention for Trauma in Schools) program for delivery within community-based settings for use with girls assessed and/or served by the child welfare system. The study utilizes a randomized clinical trial that evaluates the effectiveness of the adapted program entitled GAIN (Girls Aspiring toward Independence) compared with a usual care group. Primary outcomes of the intervention are mental health symptoms such as PTSD, depression, and internalizing and externalizing behaviors. Other outcomes include aggressive behaviors, revictimization, and aggression-related beliefs, self-efficacy, and behavioral intentions.
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.
This study will evaluate the effectiveness of a hospital-community based violence prevention pilot study designed to increase protective factors and reduce negative risk factors associated with violence of children aged 10-15. Behaviors and attitudes that relate to violence and behavior change will be assessed through a series of questionnaires administered in an interview format. Assessments will occur every nine weeks. Additionally, objective long term measures for violence related hospital visits, delinquency, and educational development will be obtained. The study will include the following interventions: 1. Brief violence prevention (BVP): a case manager administered psycho-educational intervention that will include an interactive discussion with youth regarding resources for remaining safe and preventing violence. The intervention will address the concerns and questions of youth and youth will be given information on how to access community based resources if needed. 2. Brief violence awareness (BVA): a packet of information about violence prevention and local community resources. 3. Emerging Leaders: East End: a semester (17 weeks) long curriculum based positive youth development education program held at the Boys and Girls Club of Metro Richmond, Martin Luther King Middle School site that includes case management to ensure continued engagement and participation. Specifically, it is hypothesized that: 1. Participants will report more positive youth behaviors as compared to their initial assessment. 2. Participants will report lower levels of risky youth behaviors compared to their initial assessment. 3. Participants will report increased interest in and knowledge of health professions. 4. Participants will report reduced levels of delinquency compared to their initial assessment. 5. Participants will report a reduction in the number of violence related hospital visits compared to the general 23223 population. 6. Hospital data will show a reduction in violence related activities that led to hospital visits, or delinquent behavioral involvement.
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).
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
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.
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.
A 16 session curriculum, developed for noncustodial African American and Latino fathers to improve knowledge, attitudes and skills and enable participants to remain non-violent towards their partners will be evaluated.
The purpose of the project is to examine the efficacy of a culturally-based intervention, compared to standard agency services, in enhancing self-care among Native Hawaiian women and decreasing IPV/SV perpetration and related factors among Native Hawaiian men.
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)
This study aims to enhance workplace safety by implementing a firearm safety program at Penn Medicine\'s Pennsylvania Hospital (PAH). The option to store firearms securely during visits is offered to firearm owners. The study focuses on understanding barriers and facilitators to this program and piloting methods to collect data on firearm storage device use. The approach prioritizes participant confidentiality and pragmatism. The study design involves iterative pilot testing of data collection methods and comparison of acceptance and usage rates between cable locks and lock boxes through randomization. The intended outcome is to provide evidence supporting the scalability and effectiveness of the program. The study population includes patients and visitors who accept firearm safety materials or express interest in receiving a firearm storage device. The primary outcome measure is survey response rate, with secondary outcomes including firearm storage behavior and likelihood of using a gun safety device. Additionally, the study explores variations in survey distribution methods.
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 American Academy of Pediatrics recommends that parents receive anticipatory guidance about how to discipline their children as part of the well child visit. However, physicians provide counseling only 25-40% of the time. In regard to the type of discipline, the AAP recommends that primary care providers encourage parent to use non-physical forms of discipline and discourage parents from using physical punishment. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents were exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents were invited to participate in a research study to assess their attitudes about physical punishment and other discipline strategies. The key research question of this study is: Can a brief multimedia program (i.e. Play Nicely program) affect parents' attitudes about the use of physical punishment? The time frame of the study was June through August of 2010. Data was collected immediately after the clinic visit and 2-4 weeks post clinic visit.
The purpose of this study is to determine the impact of vacant lot greening on perceptions of safety and violence for residents living around the lots. We hypothesize that people living around lots that are greened will have improved perception of safety.
Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Challenges for maintaining a healthy armed force include high rates of sexually transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other substances. The common thread through these negative health outcomes is volitional behavior. Such behaviors do not only result in illness or injury, but also negatively impact performance of military duties and threaten military readiness. Despite military leadership in setting standards and policies regarding professional behavior and universal health care for preventing and eliminating such negative health outcomes, many health problems remain. Building on our previous military research, we will evaluate the effectiveness a cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, and victimization due to IPV in male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in Fort Jackson, SC.
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.