108 Clinical Trials for Various Conditions
Primary Objective: Conduct a rigorous evaluation of a prevention-based intervention designed to mitigate the harms of adverse childhood experiences (ACEs) exposure and prevent future ACEs, substance use, and overdose within 36 communities experiencing a disproportionate burden of substance use and ACEs. The study has three aims: (1) use a cluster randomized controlled trial to test effectiveness of the Strengthening Families Program (SFP) + Family Advocate (FA) intervention on substance use, overdose, and ACEs in 18 communities compared with SFP-only in 18 communities; (2) conduct a robust process evaluation informed by the Consolidated Framework for Implementation Research (CFIR) to explore implementation barriers and facilitators; and (3) conduct a cost evaluation to accurately estimate the costs required to implement SFP and SFP+FA and assess the cost-effectiveness of SFP+FA relative to SFP alone. Findings will provide a roadmap about the best ways to help disproportionately affected communities prevent substance use, overdose, and ACEs.
Risk for substance use disorder (SUD) begins early in the life course. Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority, there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting. The investigators propose a three-year plan to collect critical pilot data to pilot test and optimize a dyadic intervention that aims to increase family resilience, strengthen coping skills, help families plan for the future, and prevent youth SUD. The 'prototype' for the intervention approach is Family Talk, an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home. The investigators have made preliminary adaptations to the model in preparation for testing. To prepare for a subsequent efficacy study, a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted. The feasibility of the intervention will be evaluated. In addition, empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained.
The overall objective of this project is to develop and obtain preliminary data on acceptability, feasibility, and initial efficacy of Native PATHS. This work is guided by the stage model guidelines for treatment development and adaptation 25. Stage 1a will occur in two sequential steps. First, the investigators will recruit youth who are in 5th - 8th grade and their family members (N=24, 12 youth, 12 adults 18+) to participate in three talking circle sessions to obtain feedback on the cultural adaptation and implementation of the treatment. Next, the investigators will conduct an open label pilot (N=9). Youth and their family members, (up to 3 per youth) will provide qualitative and quantitative feedback after each session. In Stage 1b, 60 youth will participate in a pilot randomized controlled trial, testing the efficacy of the newly created program (n=30) against a wait list control (WLC) condition (n=30). Ultimately, this program of research is expected to result in a well-specified, efficacious prevention program that could be readily disseminated and generalizable to other Indigenous populations with minimal adaptation.
The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female adolescents and their female caregivers. Specifically, investigators aim to evaluate the impact of "Asdzaan Be'eena'" or Female Pathways in English (henceforth referred to as AB) on risk and protective factors for early substance use and sexual debut through a randomized controlled trial (RCT) in partnership with the Navajo Nation. The program was developed and pilot tested through an extensive formative phase conducted by our tribal-academic partnership (IRB protocols: #00006569 and #00009117). Investigators will examine the efficacy of the AB program for reducing risk factors and improving protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use.
Our goal is to conduct a large multi-site randomized controlled trial (RCT) of a promising computer-facilitated Screening and clinician Brief Intervention (cSBI) system designed for delivery by pediatric primary care clinicians and aimed at reducing unhealthy alcohol use and related riding/driving safety risk among adolescent patients. Our setting will be the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care research network, with \>600 U.S. primary care practices having participated in recent studies. This trial addresses the evidence gap identified in the latest U.S. Preventive Services Task Force review of alcohol screening and brief counseling interventions among adolescents, and, if shown effective, the cSBI system could be widely disseminated via AAP's existing education, teaching, and advocacy platforms to its 67,000 pediatrician members, thereby greatly increasing the potential for population-level impact of alcohol screening and brief intervention for U.S. adolescents.
Researchers at the Centers for American Indian and Alaska Native Health in the Colorado School of Public Health at the University of Colorado completed an intensive community-engaged process to rigorously adapt the Strengthening Families Program for Parents and Youth 10-14 for the cultural context of a Northern Plains reservation community, creating a program optimized for American Indian families, Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong). This study will test the effectiveness of TG for delaying the onset of substance use among young adolescents. In response to requests from participating families and community partners to help address suicide risk among their youth, and based on preliminary evidence that the program may impact risk behaviors beyond substance use, the study will also test suicide risk outcomes among youth. Finally, in recognition of the potential for reciprocal influence on the adults participating in the program with their children, capitalizing on their motivation to make concomitant positive changes in their own lives, the current study will also examine effects on adult substance use. In summary, this study will test the effectiveness of TG for reducing risk for: (1) substance use among youth; (2) suicide risk among youth; and (3) substance abuse among adults.
Students' cooperative and prosocial behavior is vital to their social and academic success and to the quality of a school's social environment. This project will evaluate an instructional technique that could benefit students and schools by encouraging higher levels of prosocial behavior among students and promoting social integration and inclusion, particularly for marginalized students. The instructional technique is called "cooperative learning" which involves students working in groups toward shared academic goals. Previous research indicates that cooperative learning promotes social acceptance and increases academic engagement and achievement. However, it has not been evaluated as a technique to reduce student behavioral problems and promote greater school safety. There is strong reason to believe that it will have these benefits, since cooperative learning brings together students from diverse social groups and provides them the opportunity to work together toward shared goals in a positive setting.
This study involves adaptation, implementation, and rigorous evaluation of a family-based program designed to prevent early initiation of substance use on a Northern Plains Indian reservation. The program, Thiwáhe Gluwáš'akapi, is a cultural adaptation of the Iowa Strengthening Families Program for Parents and Youth 10-14. Youth and their parents/caregivers will participate in weekly group sessions for 7 weeks and complete pre- and post-intervention surveys assessing a variety of risk and protective factors and youth outcomes. The evaluation design will allow the assessment of the effectiveness of different components within the program.
The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. At the same time, parent monitoring of youth behavior tends to decrease during the adolescent years, creating a source of risk for not only the early onset of AOD use but also escalation. Thus, programs are needed in parenting behaviors and family relationships that are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly true of children with psychiatric disorders who are at higher risk for developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of this study is to test the effectiveness of a family-centered intervention to reduce the risk of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been referred for mental health care due to psychiatric symptomatology, will be randomly assigned to receive either an individually tailored family program or standard care. The experimental intervention, which is based on the Family Check-Up model (Dishion \& Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes principles of motivational interviewing to encourage families to change. Follow-up interviews will be conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and other risky behaviors.
Our primary goal is to conduct a pilot study of the effects of a new potential strategy for youth substance abuse prevention - science-based drug education integrated into the high school science curriculum. Through this pilot study we propose to: (1) demonstrate that this new strategy shows promise, and (2) estimate the effect size for the intervention.
This study evaluates the efficacy of a self-directed parenting program called Connecting in reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15). Half of the participants will receive services as usual from the foster system, while half will participate in the Connecting program. Connecting is a 10-week, self-directed parenting workbook with two digital video discs (DVDs). Families receive weekly telephone support as they complete the program.
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 goal of this 2-arm randomized control trial is to determine the impact of a community health worker delivered coaching intervention, GRIT, on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at baseline. The specific aims include: * Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time. * Aim 2. Examine the role of youth and caregiver self-regulation in mediating the effect of GRIT on adolescent rates of alcohol and cannabis use. Researchers will compare participants who are randomized to the GRIT intervention to an active control group, receiving a Digital Citizenship Curriculum, to see if those who participate in GRIT experience greater improvements in self-regulation and lower cardiometabolic risks. Participants will: * Be randomized to either receive the GRIT intervention (experimental group) or the Digital Citizenship Curriculum (active control group) * Complete 3 in-person visits at baseline, post-intervention, and 12-month post intervention * Complete HRV assessments using emWave Pro Plus and survey assessments on REDCap during in-person visits. * Participate in six 60-minute sessions conducted over 8 weeks via Zoom with an assigned community-health worker * Be invited to complete a booster session at 6-months post-intervention * Complete online measures at baseline, post-intervention, 6-month, and 12-month post-intervention
The primary goal of this study is to test the effectiveness of the iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) curriculum, a novel drug education and diversion program, in approximately 300 middle and high school students, who have violated their school substance use policies in the past month, as an alternative to punitive school responses for school-based substance use infractions. This randomized controlled trial will test the hypothesis that adolescents randomized to the iDECIDE curriculum will have improved substance use outcomes (i.e., knowledge, attitudes, and behavior) compared to adolescents in a waitlist control group. The outcomes of this study will measure knowledge of drug effects and brain development, perceptions of harm from substance use, willingness to quit or reduce use, and substance use behavior.
This study's goal is to partner with public libraries to prevent substance use and sexual risk-taking among urban African American adolescents (ages 13-16) affected by parental drug use. An existing universal evidence-based intervention (Focus on Youth with Informed Parents and Children Together, abbreviated as FOY+ImPACT) will be adapted for adolescents affected by parental drug use and delivered in libraries. FOY+ImPACT is a skill-building intervention aimed at preventing substance use and sexual risk-taking among high-risk African American youth. The investigative team will conduct a pilot study to assess the feasibility and initial efficacy of a library-based prevention intervention for adolescents affected by drug use. Participants will be Black adolescents (13-16 years old) affected by parental drug use (N=120). Adolescents will be randomized by partner organization to receive the intervention virtually. Pre, Post and 3-month follow-up data will be collected using computerized surveys. Primary outcomes will be substance use (i.e., marijuana and alcohol use, two of the most common drugs for this age group) and sexual risk behaviors (i.e., initiation of sex and frequency of unprotected sex).
The purpose of this research study is to determine the usefulness of the TIPS iPad app in the treatment of adolescent patients who qualify for Trauma Focused-Cognitive Behavioral Therapy (TF-CBT).
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 study is to test the effectiveness of integrating and adapting two National Institute on Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving low-income youth: 1)the Youth Risk Index (YRI) and Transmissible Liability Index-Parent (TLI-P) nurse and/or research assistant-administered screening tools for high risk of substance use (SU) prior to high school and thus also for SUD and 2) the Family Check-Up (FCU) - a brief, family-based program to prevent SU/SUD with replicated efficacy.
The purpose of this study was to determine whether a media literacy education program taught be teacher to late elementary school students (grades 3-5) positively affected students' critical thinking skills and substance use-related health outcomes.
The purpose of this study is to determine whether Motivating Youth to Reduce Infections, Disconnections, and Emotion dysregulation (MY-RIDE) decreases substance use , to determine whether MY-RIDE increases human immunodeficiency virus (HIV) prevention strategies and to evaluate MY-RIDE effects on willingness to take Pre-Exposure Prophylaxis (PrEP), stress, substance use urge, and use of mental health and substance use services when compared to attention control youth
This is a community-engaged research project that aims to identify and pilot test interventions that may reduce substance use stigma among professionals at primary care sites serving patients who might be exposed to HIV or are living with HIV. Our goal is to develop a multi-level substance use stigma intervention that leverages 1) education and 2) organizational policy to address structural drivers of stigma and the stigmatizing professional attitudes and behaviors that affect patients. Hypothesis: the results of the trial pilot research and are expected to provide scientific evidence demonstrating feasible and potentially effective substance use stigma reduction interventions that go beyond simple individual-level professional training. We plan to build on the data from this pilot trial study to then further test the multi-level intervention in another larger trial study with primary care organizations to determine whether the intervention addresses multiple complex drivers of substance use stigma that influence HIV prevention and care outcomes among people who use drugs.
The purpose of this study is to develop and evaluate the effectiveness of a web-based version of the Family Check-up (FCU). The FCU is a school-based family-centered intervention that has been developed over the past 20 years and tested across the United States with diverse populations. It focuses on enhancing parenting skills and family management in early adolescence. The FCU has been shown to be highly effective at reducing adolescent problem behavior, achievement problems, depression, and substance use over an extended period of time. In the original FCU, parents complete an assessment that evaluates family strengths and challenges. They then receive feedback from a family consultant about how their data compare to other families with children of the same age. As part of this feedback session, the consultant helps motivate parents to make changes at home that will positively impact their child and family overall. Parents and consultants decide together which child behaviors they most want to see change. The consultant then works with parents to enhance relevant parenting and family management skills. Despite the demonstrated effectiveness of this intervention, few schools have the resources and staffing to implement it without substantial support. It seems, then, that schools would benefit from an online package that requires fewer school resources to implement. The FCU-Online is designed to incorporate the successful components of the original FCU while reducing the burden on schools. And, because it is accessed online, parents can utilize this resource at a time and location convenient to them. In this study, 300 families will be randomly assigned to one of three conditions: a web/ mobile-only version of the FCU, a web/mobile + coach version, or middle school as usual. Research on mental health interventions delivered over the internet suggests that a coach or "in-person" contact enhances outcomes. However, programs that require no coaching or in-person contact are cheaper and easier for schools to deliver. Therefore, a web/ mobile-only version may allow more schools to deliver the intervention to a greater number of families and children. Thus, investigators will test the relative effectiveness of a coach version versus an online-only version at improving key parenting skills. It is predicted that changes in parenting will lead to reductions in risk behavior, such as problem behavior at school and substance use.
The objective of this study is to explore the efficacy of brief motivational interventions (BMIs) for treatment of youth with alcohol and other drug problems after at least 3 months. The results of previous studies indicate that brief interventions for unhealthy alcohol use have been shown to be effective in primary care settings, with most studies focusing on adults and few studies focusing on youth. To date, no BMI studies have been conducted in the Ukraine among youth with alcohol or other drug use. Of particular concern are emerging adults ages 18-25 who may be at particularly high risk for alcohol problems given historical events related to the fall of the Soviet Union and the subsequent economic down turn. This study will evaluate the efficacy of BMI by comparing BMI and no BMI conditions among two samples of youth screening positive on the prescreen survey for risky drinking. The subject pool will come from the Psychoneurological Department: the first location is located in the Railway Clinical Hospital, its clinical base, and the second in classes in the department at Kiev National Medical University. The total sample of 120 will be broken down to 1.) 60 patients from Railway Clinical Hospital; and 2.) 60 students from Kiev National Medical University. Participants will be stratified by recruitment site and randomized to condition: BMI and control, with follow-up assessment at 3 months. In addition to being the first of study to evaluate the efficacy of BMI on substance use problems among youth in Ukraine, this study will examine BMI intervention processes in relation to alcohol and other drug outcomes. Findings will inform research and clinical practice to enhance early identification and prevention of problematic alcohol use trajectories among emerging adults
Relapse contributes significantly to the chronicity of substance use disorders, one of the most costly medical/mental health problems facing our nation. The incorporation of exercise into relapse prevention efforts will address stress, a critical factor in relapse, provide other health benefits, and improve overall quality of life. Combined, these changes will reduce the risk of relapse to substance use while also lessening the burden of this psychiatric disorder upon society
Oregon's decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use services and mitigate the growing opioid and methamphetamine epidemics in their state. Consistent with the HEAL Data2Action call for Innovation projects that drive action with data in real-world settings, this study will refine and test the impact of a novel implementation strategy to engage cross- sector decision makers and make data that they identify as relevant to their decisions available to them in easy- to-use products. The proposed study aims to not only address critical knowledge gaps regarding how and when data can inform impactful, transparent decision-making, but to provide decision makers with the data that they need to achieve community-wide substance use prevention and treatment goals, including the increased delivery of high-quality, evidence-informed, services and the prevention of overdoses.
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.
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.
More than 90% of women in substance use treatment report history of physical and/or sexual trauma, and up to 60% meet criteria for both substance use disorder (SUD) and Post Traumatic Stress Disorder (PTSD). PTSD typically precedes onset of SUD, with substances used as a means to cope with physiological, psychological, and emotional symptoms resulting from the trauma. Women with PTSD experience greater severity of addiction symptoms, readmit into treatment more frequently than women without PTSD, and tend to have poorer treatment outcomes. Due to increased risk for exacerbation of PTSD on SUD severity and treatment success, and the specific vulnerabilities and needs of women with this comorbidity, SUD treatments that target both substance use and trauma recovery are needed. However, few interventions target both SUD and PTSD concurrently, and fewer still are specific to women. Mindfulness-Based Relapse Prevention (MBRP) has been shown to decrease craving, relapse rates, and quantity/frequency of use across several substances, and has shown acceptability in diverse populations. MBRP integrates mindfulness practices with cognitive behavioral and exposure-based approaches to increase self-regulatory skills while experiencing triggers previously associated with substance use, including challenging affective states such as those common to experienced trauma. Adapting MBRP to incorporate trauma education and treatment approaches has the potential to effectively treat women with the dual vulnerabilities of trauma history and SUD. The current study is thus designed to determine feasibility, acceptability, and initial efficacy of an adapted Trauma-Informed Mindfulness-Based Relapse Prevention (TI-MBRP) intervention for women in substance use treatment settings who have PTSD. TI-MBRP integrates trauma education and treatment approaches drawn from Cognitive Processing Therapy (CPT) into the standard MBRP protocol to provide a trauma-informed approach to treating women in substance use treatment settings. The current proposal will evaluate TI-MBRP, using a randomized, pre-post design, with 100 women in residential substance abuse treatment. Participants will be randomly assigned to participate in a 4-week TI-MBRP intervention or to continue with treatment as usual (TAU). Assessments will be collected pretest, posttest, and at one-month follow-up. Data from this study will lay the groundwork for a larger scale clinical trial to determine the efficacy of TI-MBRP.
Adolescents with substance use disorders (SUD) are at substantial risk for contracting HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction interventions have been developed to meet their unique needs, and none use a family-based intervention approach, which the literature recommends as the focus for intervention for youth. Current state policies neither require providers in clinics delivering substance use treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for HIV/STI prevention. There is clear public health need to develop innovative methods of service delivery and effective strategies of HIV/STI sexual risk reduction that address multiple contexts of risk (i.e. family) for this high risk population. The current proposal addresses this need by developing a provider-delivered HIV sexual risk reduction intervention to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help families under their care to more comfortably address the adolescent's sexuality; 2) promotes youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in care.
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.