292 Clinical Trials for Various Conditions
The goal of this study is to test the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in youth (aged 18-25 years) with elevated depressive symptoms who are overweight/obese and/or self-report parental history of overweight/obesity. Eligible participants will be randomly assigned to one of two groups: one group will use the Vira mobile app intervention with support from a health coach, and the other group will use the Vira mobile app intervention without coaching. Both groups will use the app for 12 weeks.
The purpose of this investigation is to conduct a feasibility study to evaluate the potential for implementing the developed decision support tool with Latina, Black, and non-Latina White women. The investigators will collect feasibility data and assess the use of the decision support tool with end-users. The aim is to determine if women using the decision support tool make more informed choices measured by knowledge, attitudes, and intentions.
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications
This pragmatic clinical trial is being conducted to test the effectiveness of I-SITE (Implementation for Sustained Impact in Teleophthalmology), an implementation program to sustain increased diabetic eye screening rates using teleophthalmology in rural, multi-payer health systems. Up to 10 rural health systems providing teleophthalmology to 10,000 patients with diabetes and 100 clinical care personnel participating in the I-SITE intervention will be enrolled for up to 48 months.
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
The goal of this clinical trial is to learn if a substance use prevention intervention decreases substance use, increases resistance skill use, and decreases substance use risk in intermediate school students. The main questions it aims to answer: Does the intervention decrease 30-day substance use? Does the intervention increase 30-day resistance skill use? Participants will be asked to participate in the intervention and provide their self-reported answers to behavioral questions before and after the intervention.
The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.
This project is designed to test the Coalition Check-Up (CCU)-a theory-based and data-driven technical assistance (TA) system that supports community coalitions' implementation of evidence-based programs (EBPs) for drug prevention. The primary aims of the project are to: 1) Estimate the impact of the CCU on coalition capacity. Coalitions will be randomly assigned to the CCU or a 'TA as usual' condition to evaluate whether the CCU improves coalition capacity as measured by coalition member reports of team processes, network composition, and collaborative structure. 2) Estimate the impact of the CCU on implementation of evidence-based programs. The study will test the hypothesis that coalitions receiving the CCU will implement EBPs with greater: a) quantity, b) quality, and c) sustainability. The study will also test coalition capacity as a mediator of CCU impact on EBP implementation. 3) Estimate the impact of the CCU on youth substance use. The study will test the hypothesis that communities receiving the CCU will reduce youth substance use relative to communities in the comparison condition. The study will also test EBP implementation as a mediator of CCU impact on youth substance use.
The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.
Primary Objective: To characterize the frequency of bleeding episodes (BE) while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor concentrate or bypassing agent (BPA) prophylaxis. Secondary Objectives: * To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis: * the frequency of spontaneous bleeding episodes * the frequency of joint bleeding episodes * health related quality of life (HRQOL) in participants greater than or equal to (\>=) 17 years of age * To characterize the frequency of bleeding episodes during the onset and treatment periods in participants receiving fitusiran. * To characterize the safety and tolerability of fitusiran. * To characterize the annualized weight-adjusted consumption of factor/BPA while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis.
This Phase II STTR will evaluate an interactive, self-paced, e-learning media literacy intervention, REAL media, to prevent youth substance use among youth in the 4-H organization. Participating 4-H clubs will be randomly assigned to use the curriculum or continue current practices with the option for delivery at the end of the study. 4-H members (ages 13-15) will complete a pretest, immediate posttest and follow-up posttests at 3 and 9 months to assess effects.
To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.
This study will determine the clinical effectiveness, moderators and mechanisms of change, and economic impact of an integrative, family-based intervention that concurrently targets change in HIV/Sexually Transmitted Disease (STD)-associated risk behaviors, drug abuse, delinquency, arrest and mental health outcomes for juvenile offenders committed to a juvenile justice day treatment program.
The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision. This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.
This study is a randomized controlled trial (RCT) that will rigorously evaluate the implementation, effectiveness and cost-effectiveness of a couple-based integrated human immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with drug-involved male offenders charged with misdemeanors and their primary female sexual partners, implemented by frontline providers in Criminal Court, Community Court or probation (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.
The study has the following primary aims: (1) to test whether participants assigned to CNU (a 7-session, manualized intervention entitled "Connect 'n Unite") engage in lower HIV/STI behavioral risk compared to participants assigned to WP (a wellness promotion attention control condition); (2) to test whether participants assigned to CNU have lower cumulative incidence of STIs-chlamydia and gonorrhea-confirmed via biological assay compared to participants assigned to WP; and (3) to test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.
This randomized controlled trial is designed to address gaps in couple-based HIV prevention research by focusing exclusively on HIV negative concordant couples where one or both partners are drug-involved. Building on prior couple-based HIV research that resulted in an evidence-based HIV prevention model for couples (Connect), intervention components were modified to address dyadic drug risk reduction and drug-related unsafe sex and a couple-based HIV risk reduction intervention (Connect II) was designed specifically for drug-involved, HIV negative concordant heterosexual couples at risk for HIV/STIs. For this RCT, couples are recruited primarily through street outreach in drug using locations and randomized into one of three arms: (1) couple-based HIV Risk Reduction condition; (2) individual-based HIV Risk Reduction, which delivered the same content as the couple-based condition but was provided to either the male or female drug-using partner alone; or (3) couple-based Wellness Promotion, which served as an attentional control arm. This RCT tests two major hypotheses: (1) whether the HIV risk reduction intervention provided to the couple or an individual partner would be more efficacious in decreasing number of unprotected acts of intercourse and having a lower cumulative incidence of biologically confirmed STIs over the 12-month follow-up period compared to the Wellness promotion control arm and (2) whether the couple-based HIV risk reduction intervention would be more likely to decrease the number of unprotected acts and have a lower cumulative STI incidence compared to the Individual HIV Risk reduction Arm.
The investigators are testing the efficacy of a family-based preventive intervention, which began when the children were age 2, with children at risk for developing significant conduct problems. Families who were originally recruited from Women, Infants and Children (WIC) were randomly assigned to a family-centered intervention developed by Dishion and colleagues (Dishion \& Kavanagh, 2003; Dishion \& Stormshak, 2006) referred to as an 'ecological approach to family intervention and treatment' (EcoFIT). The current study expands the Early Steps intervention into the elementary school years beyond what is currently available for a WIC service delivery venue, in which children are no longer eligible for services at age 6. The investigators are testing the hypothesis that periodic, tailored, and adaptive interventions delivered to caregivers at school entry will (a) reduce the probability of elevated risk associated with early-onset problem behavior, including the eventual use of drugs and other health-risking behaviors; (b) reduce the likelihood of mental health problems such as childhood depression, anxiety, conduct problems and co-morbidity; and (c) promote children's development of self-regulation, which underlies school readiness, early school literacy academic achievement, and positive peer relations.
In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. The Family Management Intervention is comprised of a parent-focused curriculum to foster parenting skills followed by brief family therapy to foster adaptive family communication and age-appropriate roles. The Teen Achievement Intervention is comprised of a clinician-delivered learning strategy curriculum to foster academic achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and prosocial peer networks. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of the Family Management and Teen Achievement components on post intervention drug use, problem behavior, psychological distress, and academic achievement of indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated pathways by which the interventions might reduce drug involvement and problem behavior by promoting changes in targeted skills and behavior change processes. The possibility of effect-modification also is considered, with a focus on neurocognitive, internalizing/externalizing, and demographic factors, in an effort to discern why interventions work for some youth but not others. This application revision has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. In response to a key limitation, this revision includes further specification of anticipated relationships between neurocognitive variables, skill acquisition levels, and prevention intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive effects are informed by empirical findings and the clinical experience of investigative team members specializing in neuropsychology. If successful, this project should improve prevention practices by identifying malleable behavior change processes fostered by effective interventions. Improving our understanding of how individual characteristics of indicated youth, such as neurocognitive deficits or externalizing problems, influence the development of skills during interventions and subsequent outcomes may also help to improve existing prevention interventions. The significance of the proposed study is underscored further by the substantial size of the targeted population of indicated youth, and the range of morbidities and mortality that often result when early warning signs of drug abuse are not addressed.
This study concerns the safety of blood transfusion. Prior to transfusion, staff should perform a number of essential safety checks to ensure that the correct patient is receiving the correct blood product. Evidence suggests that these safety checks are not always done. This study has been designed to assess the effect of a simple intervention on the performance of the bedside safety check. The hypothesis is that a simple intervention will improve the performance of the bedside check.
Parental involvement has been shown to be a robust predictor of child conduct problems (CP) and drug use risk in childhood and adolescence, but relatively little attention has been paid to the role of parental involvement in relation to child problem behavior during the transition to school-age, when children are spending more time in school, after-care settings, and in the neighborhood. Concomitantly, as children transition from preschool to school-age, there is evidence to suggest that the quality and organization of schools, after-school care, and neighborhoods play an increasingly important role in the emergence of children's CP and drug use risk. Specifically, we will address: 1) the extent to which the quality of school environments, after-school care, and neighborhoods are associated with the emergence of CP during the early school-age period; 2) how parental involvement in the toddler and preschool period may be associated with parental involvement and monitoring in extra-familial contexts in the early school-age years; 3) how parental involvement in schools, after-care, and the neighborhood, may moderate relationships between extra-familial factors and children's CP; and 4) whether a parenting intervention can increase parental involvement in school, after-care, and neighborhood contexts and decrease risk of children's subsequent CP. These issues will be tested with an existing sample of 731 ethnically-diverse children from urban, suburban, and rural sites. As all families in the study were recruited based on the presence of sociodemographic, family, and child risk factors, the cohort of children are at high risk for displaying a persistent trajectory of clinically-meaningful CP and drug use risk. Thus, the study has the potential to fill a much-needed void on associations between extra-familial contexts and risk for early-starting CP and later problem behavior during the early school-age years. Equally critical, the study can provide data on the potential moderating influence of involved parenting, its malleability for families facing multiple adversities, and whether family-based interventions can make a difference for children facing multiple adversities.
This five-year prevention services application is concerned with preventing substance abuse, comorbid mental and behavioral disorders, and school failure. We will direct an integrated set of first grade classroom based preventive interventions at two correlated and confirmed early antecedents: early aggressive, disruptive behavior and poor achievement. We will test a comprehensive Whole Day (WD) program directed at improving: 1) teacher's classroom behavior management; 2) family/classroom partnerships regarding homework and discipline; and 3) teacher's instructional practices regarding academic subjects, particularly reading. We will test WD effectiveness in a developmental epidemiological design in which children and teachers are randomly assigned to intervention and standard setting (control) classrooms in 2 classrooms in each of 12 schools. While following the first grade children to the end of third grade, we will follow their first grade teachers over two subsequent cohorts of first graders to test whether the support and training structure sustains high levels of WD practice. We will also test whether the support and training structure is successful in training non-WD teachers. This prevention services aim will be augmented by an economic analysis of the costs and cost-effectiveness of the WD program. This combined services and prevention research should increase the efficiency of developing evidence-based programs and extending their use system-wide in both the prevention and education fields. The aims of our proposed work are to: 1) Implement and evaluate the effectiveness of a whole-day preventive intervention program for first-grade (WD) directed at known antecedent risk factors for later substance abuse, school failure, and comorbid mental and behavioral disorders; 2) Measure the variation in impact of WD due to variation in the experimentally manipulated quality of teachers' specific WD practices around classroom behavior management, family/classroom partnership, and quality of instruction, regarding reading, taking into account family, peer, and community factors; 3) Test effective- ness of the support structure required to sustain, and extend to other teachers high quality implementa- tion of WD; 4) Carry out economic analyses of the costs of implementing WD and their cost-effectiveness.
This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. Participants for this study will include 200 patients diagnosed with opioid use disorder (OUD), that are enrolled in a 60-day residential addiction treatment program and prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.
Cesarean deliveries are the most common surgical procedure performed in the United States. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin, widely used before skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is cost-effective and reduces overall rates of endometritis, wound infection, readmission, use of antibiotics and serious maternal events. Azithromycin has effective coverage against Ureaplasma, associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients.
To examine the effects on participants who play the smokeSCREEN game in that the game will have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other outcomes related to smoking and tobacco products.
Objectives * Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. * Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
This project is a hybrid efficacy/effectiveness trial of a streamlined version of the Bridges program, an evidence-based intervention (EBI) to prevent substance abuse and mental health disorders. Bridges is an integrated parent-youth intervention evaluated in a randomized controlled trial (RCT) with Mexican Americans (immigrant and U.S. born) that showed long-term effects on multiple outcomes: substance use initiation and escalation, externalizing and internalizing symptoms, deviant peer association, and grade point average (GPA) in early adolescence; alcohol abuse disorder, binge drinking, marijuana use, risky sexual behavior, diagnosed mental disorder, and school dropout in late adolescence. Building on evidence of core intervention components and strategies for redesigning EBIs for the real-world, investigators will partner with low-income, multiethnic schools to adapt the program to a brief, 4-session format (Bridges short program, BSP), and optimize engagement, delivery, training, and implementation monitoring systems to facilitate dissemination and sustainability. The proposed RCT will also examine whether a parent-youth EBI can impact multiple channels of youth self-regulation (e.g., biological, behavioral, emotional) during adolescence when neurobiological systems are changing rapidly, and whether preexisting individual differences in self-regulation moderate program effects.
This pilot study conducts feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework that seeks to preempt the progression from early drug use to more chronic abuse and dependency. The study will explore moderators representing two frameworks, risk severity and differential sensitivity. Moderators will be explored in their ability to influence the differential efficacy of two adolescent drug abuse interventions.
The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse treatment clients to either the experimental intervention or to a wait list control group; and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based intervention. They study hypothesis are the following: 1. participants in the intervention condition will report greater reductions in sexual risk behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared to the control group; 2. participants will report greater reductions in drug risk behaviors (e.g., sharing injection equipment, drug use during sex) from baseline to 3 month follow-up compared to the control group; 3. participants who report more HIV prevention information, motivation, and behavioral skills will report fewer sexual risk behaviors.
The purpose of this study is to determine a computer- and family-based drug abuse prevention program is able to reduce drug use among early adolescent girls.