114 Clinical Trials for Various Conditions
The goal of this clinical trial is to evaluate an adapted version of the radKIDS® Personal Empowerment and Safety Education Program in randomly assigned 4th grade classrooms. The primary hypothesis is that students in the radKIDS study arm will have significantly higher growth in safety knowledge, safety skill self-efficacy, confidence in help-seeking and in maintaining personal safety, and self-esteem compared to classrooms in the business as usual condition. At the student level, researchers will compare 4th grade students in classrooms randomized to receive the radKIDS program to those in classrooms receiving their regular instruction. Student participants will complete two surveys a few months apart assessing safety knowledge, self-efficacy, and self-esteem. In the radKIDS2.0 arm, students will receive the radKIDS program between the two surveys. In the control arm, students will receive instruction as usual.
The goal of this clinical trial is to test the equivalence of two delivery modalities of a universal child sexual abuse prevention program, Safe Touches: usual vs. modified. The aims are to: 1. Determine the equivalence of effectiveness between usual and modified Safe Touches 2. Assess the maintenance of gains between usual and modified Safe Touches 3. Examine factors that may impact the future dissemination and implementation
The study will use focus group methodology in the formative evaluation phase. Focus group methodology provides a rich source of data and understanding of phenomena by allowing the researcher to examine the interaction among participants
The purpose of this study is to help individuals and their caregivers develop a plan on how to recognize, deal with and respond to abusive situations.
Sharp increases in substance use rates among youth in Mexico are a major concern, both in Mexico and the US. Although the Mexican government has elevated substance abuse prevention as a national priority, there are few school-based universal prevention programs to choose from that are culturally grounded, empirically tested, and shown to be efficacious. This study aims to address this gap by adapting, implementing, and testing the keepin' it REAL (kiR) prevention intervention in Mexico's three largest cities: Mexico City, Guadalajara, and Monterrey. kiR is a model program for middle school students on the US National Registry of Effective Programs and Practices, shown to be efficacious and cost-effective in reducing substance use among large multi-ethnic and Mexican American samples in the US. The proposed study will leverage the bi-national research team's expertise in developing and adapting kiR and build upon a series of feasibility studies across Mexico which showed that kiR's core elements are applicable there. However, evidence also suggested that further adaptation is needed to enhance the intervention's cultural fit. During the proposed study's Phase 1, students and teacher-implementers in three schools-one from each of the cities-will provide feedback about the original curriculum and identify culturally and contextually relevant scenarios and examples. The bi-national research team-including original kiR curriculum designers-will collaborate to ensure cultural applicability in Mexico and fidelity to core elements of kiR. In Phase 2, the efficacy of the culturally adapted Mexican version of kiR, relative to the original version of kiR and to a control condition, will be tested through an intent-to-treat analysis in a randomized controlled trial with 7,768 7th grade students in 36 middle schools, 12 from each city. The study will investigate and incorporate into the curriculum gender specific experiences with drug offers and appropriate drug resistance strategies in the Mexican context that may impact the youths' risk of substance use and their responsiveness to prevention programs. In light of rising violence in Mexico, a secondary aim of the study is to investigate how youths' perpetration, victimization, and witnessing of violence may moderate the efficacy of kiR in Mexico. The study will create knowledge relevant to efficacious prevention approaches for Mexican-heritage youth on both sides of the US-Mexico border. Prevention science will be advanced by understanding how culturally influenced gender norms affect substance use offers, attitudes, and behaviors, as well as the success of universal prevention programs. In addition, the study will add to knowledge on how to execute collaborative, cross-national, translational prevention intervention research.
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.
The investigators are developing an interactive, web-based program for youth ages 12-17 focused on the prevention of prescription opioid abuse because to the investigators knowledge, no science-based, interactive program focused on the prevention of prescription opioid abuse among youth exists. This program is grounded in a scientific understanding of risk factors for prescription opioid abuse among youth, employs informational technologies which are effective in promoting relevant knowledge and skills, and presents program content using strategies shown to be highly appealing to adolescents. In the completed Phase 1 of this project, the investigators developed and demonstrated the scientific, technical and commercial merit and feasibility of a prototype of a web-based, prescription opioid abuse prevention program for youth. In Phase 2, the investigators will complete the development of all components of the multimedia, prescription opioid abuse prevention program and conduct a randomized, controlled trial with youth to evaluate the effectiveness of the web-based prevention intervention in increasing knowledge about key issues relevant to prescription opioid abuse among youth, skills acquisition relevant to preventing their misuse, negative attitudes about prescription opioid misuse, and perceived risk associated with their misuse. The investigators will also assess the program's effectiveness in reducing intentions to misuse prescription opioids. If this tool is shown to be effective, the investigators plan to embed it in a suite of science-based, technology-delivered tools focused on the prevention and treatment of substance use disorders that have been developed and deployed in a wide array of settings by the investigative team.
The purpose of this study is to determine if a new substance use prevention curriculum for rural middle schools is effective in reducing substance use and to study how prevention curriculum get implemented by teachers.
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 primary goal of the study is to conduct a rigorous evaluation of the sexual abuse prevention program entitled, "Safe Touches: Personal Safety Training for Children (Safe Touches)." The main study hypothesis is that children who receive the Safe Touches intervention will show greater improvement on their knowledge of inappropriate touches compared to children who do not receive the intervention.
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.
This study will implement a school-based program to prevent depression, academic failure, and substance use in at-risk adolescents transitioning from middle school to high school.
This study is designed to develop and test a gender-specific, web-based drug abuse prevention program. Study participants will be adolescent girls aged 13 and 14 years who will complete all measures online. Randomly assigned girls will also interact online with a skills-based program and subsequent annual booster sessions. The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among girls assigned to receive the intervention.
If science is to inform effective substance misuse prevention policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence, yet our field lacks an evidence-based model designed for this purpose. Accordingly, a state-level randomized controlled trial (N = 30 states) of a formal, theory-based approach for appropriately supporting policymakers' use of scientific evidence--known as the Research-to-Policy Collaboration (RPC) Model is proposed. This work has the potential to reduce population-level substance misuse by improving the use of scientific information in policymaking, thus increasing the availability of evidence-based prevention programs and policies.
This study aims to understand what influences the adoption and implementation of an innovative approach to pediatric primary care by medical professionals and staff providing that care. The innovation concerns addressing common psychosocial problems such as parental depression and substance abuse. Different approaches to training medical professionals will be examined as well as the use of software versus traditional 'paper and pencil' to facilitate implementation.
An estimated 40% of patients in mental health treatment settings engage in hazardous alcohol and/or drug use. One model of intervention that has been shown effective in medical settings to reduce alcohol use and/or promote engagement in addiction treatment is screening, brief intervention, and referral to treatment (SBIRT). Despite the effectiveness of SBIRT for risky alcohol use in medical settings, there has been no research on the effectiveness of SBIRT in mental health treatment settings. Given the proportionately large number of mental health patients who also engage in hazardous substance use, research is needed to find an appropriate and effective substance use intervention for patients in these settings. The proposed study uses a randomized controlled trial to examine the extent to which the World Health Organization's SBIRT model, the ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test) and its associated brief behavioral intervention, leads to reductions in substances prevalent in mental health settings: alcohol, cannabis and stimulants (i.e., cocaine and methamphetamine). The study will also examine the effect of SBIRT on improvement in psychiatric symptoms, improved quality of life and for those whose level of substance misuse indicates a need for treatment, initiation and engagement into SUD treatment services. Eligible participants will be mental health patients who report any past year use of cannabis or stimulants or at least one heavy drinking day in the past year. Mental health patients (N=750) who meet eligibility criteria will be enrolled and randomly assigned to either the SBIRT intervention condition or to a health education attention control condition. Participants will be assessed at baseline on substance use, psychiatric symptoms and quality of life. Each participant will be assessed at 3-, 6- and 12- month follow up points for alcohol and drug use, involvement in SUD treatment services, severity of psychiatric symptoms and quality of life. If successful this study will yield valuable new knowledge about the effectiveness of SBIRT in mental health treatment settings and will promote improved well being of mental health patients. Further, the study will provide evidence on the effectiveness of SBIRT for reducing illicit drug use. Results from this research will be used as the basis for broader dissemination and of SBIRT in mental health settings.
The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
Our broad goal is to help prevent child maltreatment (CM) by modifying pediatric practice to be more responsive to prevalent psychosocial needs of many children and families.Training pediatricians to address key risk factors for CM, the Safe Environment for Every Kid (SEEK) model aims to support parenting and family functioning, reducing the risk for CM while helping promote children's health, development and safety. We are building upon the existing pediatric primary care system and strengthening the training of pediatricians. The project also builds on our extensive research and clinical expertise in CM and in prevention (Black \& Dubowitz, 1999, Dubowitz et al., 1998, 1999, in press; Dubowitz \& Guterman, 2005, Gaudin \& Dubowitz, 1997). We have developed and implemented an enhanced model of pediatric primary care, taking advantage of the enormous opportunities of the existing pediatric primary care system, with its regular contact with young children and parents (Dubowitz \& Newberger, 1989; Dubowitz, 1989, 1990; Green, 1994). Pediatricians typically devote over half their time to checkups, focusing on prevention. There is increasing recognition that pediatric care must incorporate aspects of parental and family functioning and collaborate with community resources (Academy of Pediatrics, 1998; Green, 1994b). The broad goal of this project is to implement concepts that have been embraced by the field of pediatrics, but have not been applied and tested.
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.
The purpose of this study is to determine whether an in-home, paraprofessional-delivered family strengthening curriculum entitled Family Spirit is effective at increasing parental competence, improving maternal outcomes and improving childhood outcomes in a sample of at-risk teen mothers living in four Native American reservation communities. The effectiveness of the Family Spirit curriculum will be determined by comparing outcomes of mothers who receive the intervention plus assisted transportation to prenatal and well baby visits (called Optimal Standardized Care) to mothers who receive only Optimal Standardized Care. Outcomes will be assessed at multiple intervals over the course of a 39-month study period.
The goals of this study are to evaluate the effects of an in-home parenting education program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and substance use compared to a breast-feeding education. In addition, we will assess aspects of mother/child interaction.
This study will evaluate how effective mood stabilizers are in the treatment of bipolar disorder with comorbid alcoholism
The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my Journey program for adolescents receiving treatment in an outpatient substance abuse center. The primary hypotheses are that, relative to the control condition, Navigating my Journey will be associated with significantly higher motivation, higher self-efficacy, improved relapse coping skills, and lower substance use. The secondary hypotheses are that, relative to the control condition, Navigating my Journey will be associated with increased therapeutic alliances with counselors.
The purpose of this study is to assess the safety and effectiveness of buprenorphine for treatment of concurrent intravenous heroin and cocaine dependence.
The purpose of this study is to assess the safety and effectiveness of buprenorphine for treatment of concurrent intravenous heroin and cocaine dependence.
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.
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 is a feasibility study designed to inform the development of a multinational study of the effectiveness of a tertiary prevention program for child sexual abuse. This study targets adult men who have engaged in child sexual abuse, and will be implemented within the Minnesota Department of Corrections. Data will include measures of the implementation process, short-terms changes in criminogenic factors, and staff and participant factors that could influence outcomes.
The goal of this clinical trial is to test the effectiveness of a parent-focused child sexual abuse prevention program (Smart Parents) delivered to parents enrolled in a parent education program (Parents as Teachers; PAT). The main questions the trial aims to answer are: 1. Does PAT + Smart Parents improve parents' CSA-related awareness and protective behaviors compared to PAT as usual? 2. Are potential gains maintained 12- and 24-months post intervention? 3. What parent-, provider-, and organizational-level factors hold promise for future dissemination and implementation efforts?