74 Clinical Trials for Various Conditions
Early alcohol socialization occurs within the family. This multi-level, high-reach, low-intensity intervention to prevent early alcohol use capitalizes on the influence of providers, immunization timing, and pediatric guidelines that advise healthcare providers to give anticipatory guidance about early alcohol use. In conjunction, the intervention capitalizes on the power of technology to reinforce and expand upon pediatrician messages. The study seeks to understand the feasibility and effectiveness of a pilot intervention designed to prevent alcohol socialization through education of parents of rising 6th grade students.
Heavy episodic drinking (HED) among college students remains a concern within the U.S., as rates of HED are still high in this population. Though a variety of brief motivational interventions for alcohol use in college students have demonstrated significant effects, these effects are often small and not consistently maintained over time. Personalized feedback interventions (PFIs) are a particularly promising approach, as these are often acceptable to college students, as well as low-cost, and easy to disseminate. Though presentation of interperson discrepancy via descriptive and injunctive norms has shown consistent effects within PFIs and received much attention in the literature, intraperson, or ideal-actual self discrepancies, has largely been ignored. Drawing from cognitive dissonance theory, self-regulation theory, and motivational interviewing, the current study aims to evaluate the efficacy of an alcohol PFI with a values component to incorporate ideal-self discrepancy into a typical intervention.
MB-College (MBC) is an 9-week, 9 session program (i.e., the study intervention being tested in the RCT) providing systematic and intensive training in mindfulness meditation practices, applied to health behaviors relevant to college students and young adults. The MBC intervention will be administered live, online via the free video conferencing platform, Zoom, to all eligible study participants enrolled in the active arms of the study. In addition to the 9-week, 9 session MBC class, referred to as "standard dose MBC" from here on out, investigators will also be testing a "low-dose MBC" version of the intervention, where each weekly session will run 1.5 hours in length rather than 2.5 hours. This is a 3-arm randomized controlled trial. The standard-dose and low-dose versions of the MBC intervention will be compared to a third arm of the study, a health education active control group. Members of the control group will be offered the MBC class upon completion of the research study. The Study Aims are to: (1) Evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). (2) Evaluate impacts of MBC standard-dose vs. MBC low-dose vs. health education control group on health conditions relevant for emerging adults, demonstrated to be influenced by MBC in a prior study, specifically depressive symptoms, loneliness, and sedentary activity. (3) Explore mechanisms by which MBC may exert effects on aforementioned health conditions, including interoceptive awareness, decentering, and perceived stress. Participant Population: young adults aged 18-29 years of age, residing in the United States who screen eligible will be invited to enroll. Students will be screened using a two-part process taking place online. Research assessments at baseline and 3-month will take place digitally using Qualtrics, LLC (Provo, UT, USA) survey management tool. Participants will be sent secure links via email that can be accessed with their participant identification number. Enrolled participants will be randomly assigned to one of three groups: (1) standard MBC; (2) low-dose MBC or (3) health education control group. The control group will be given the opportunity to participate in the intervention after the study MBC course is completed and follow-up assessments have been administered.
Mindfulness interventions are increasingly offered to undergraduate students at universities world-wide, however the evidence base is very limited. The objective is to evaluate effects of a customized mindfulness intervention (called Mindfulness-Based College) on undergraduate student health. A superiority randomized controlled trial with parallel groups will be performed with 30 participants in each arm. Participants will be randomly assigned to Mindfulness-Based College or health education waitlist control. Investigators will be blinded to treatment allocation. Participants will be assessed at baseline, 10 weeks, and six months. The primary outcome is a college health summary score, including seven evidence-based determinants of health particularly relevant to college student well-being: body mass index, physical activity, diet, alcohol consumption, sleep quantity, perceived stress, and loneliness. Primary intention-to-treat analyses will evaluate whether MB-College vs. control is associated with the summary score, utilizing generalized linear models. Secondary analyses will evaluate which, if any, of the seven determinants of health are driving associations.
The objective of this study is to adapt and test the feasibility of a 4-week motivational interviewing mHealth intervention, Tracking and Reducing Alcohol Consumption (TRAC), to reduce alcohol use among adolescent and young adult (AYA) cancer survivors during post-treatment survivorship. At the end of this study, the feasibility data gathered will inform a definitive randomized controlled trial of TRAC-AYA to test the efficacy of the adapted intervention.
The purpose of this research is to examine the effectiveness of the Computerized Alcohol Screening and Brief Intervention (CASI) in adolescent patients in the Emergency Department at the UC Irvine Medical Center. This research study will evaluate the effectiveness of the brief intervention compared to standard of care (no intervention). Brief interventions have a high potential impact in ED. Computerized alcohol screening and brief intervention (CASI) is a fast and easy to use tool for patients and healthcare providers. CASI provides the Alcohol Use Disorders Identification Test (AUDIT-C)4, from the World Health Organization and CRAFFT3, followed by a brief intervention and customized alcohol intake recommendations for the patient. This study will also determine the effectiveness of the brief intervention in reducing alcohol use/abuse in adolescents between 12-17 years of age. The overall goal of this study is to identify at risk alcohol use/abuse in adolescents and provide an intervention at an early stage. The current data to support alcohol and screening and brief intervention in adolescents is limited. The researchers hope that this research study will add to the overall body of knowledge in support of using the emergency department as a tool in public health, as it relates to the individual patients morbidity and mortality (pancreatitis, cirrhosis) and to the societal costs of alcohol use (lost days of work, motor vehicle collisions).
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study the effects (both good and bad) of combining quetiapine and topiramate for reducing use of alcohol.
The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages. Parents/caregivers of youth are encouraged to use a freely available app to guide conversations with their child about drinking. This study will have significant impact by evaluating response to these scalable interventions which can be deployed widely in clinical care settings.
This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant supplement, on brains of youth (ages 15-19) using magnetic resonance imaging (MRI).
The proposed research will be the first study to focus on experimentally manipulating both injunctive and descriptive norms on social networking sites in order to elucidate the relationship between alcohol and abstainer displays on social networking sites and subsequent alcohol cognitions, use, and related negative consequences. Based on literature focusing on developmentally appropriate health models for adolescents, the Prototype Willingness Model (PWM) assumes that health-risk behaviors occur either when individuals have developed intentions to engage in a risk behavior (and these intentions vary as a function of attitudes and perceived injunctive norms) or through willingness to engage in risks (which varies as a function of perceived vulnerability to negative consequences, perceived descriptive norms , and prototypes). To fully understand the relationships between alcohol abstaining displays on social networking sites, we will examine 1) the role of descriptive and injunctive abstainer and user norms, when experimentally manipulated with SNS profiles, on willingness and intentions, subsequent alcohol use and related negative consequences among adolescents (age 1 5-20) 2) whether intentions and willingness mediate the relation between our experimental manipulation and subsequent alcohol use and negative consequences and whether 3) individual differences in social influence moderate the effect of the experimental manipulation on intentions, willingness, alcohol use, and negative consequences. We will test these aims by recruiting a community sample of adolescents (N = 300), living in the greater Seattle metropolitan area. Participants will complete a web-based baseline assessment and participate in an in-person experimental manipulation in which they are either assigned to see same-sex social networking site profiles of alcohol abstainers, abstainers +users, or a control condition where neither user or abstainer information will be provided. Immediately after the manipulation, participants will answer a series of questions about the profiles they just viewed and their alcohol-related cognitions. Participants will also complete a one-month in person follow up assessment to test for impacts on intentions, willingness, alcohol use, and related negative consequences. Additionally, individual differences in social influence will be examined as possible moderators o f the relationship between SNS-portrayed norms and our primary outcomes. This study is both significant and innovative in that it uses a theoretical perspective to experimentally test the impact of alcohol content, in particular abstainer norms, on Facebook on adolescent alcohol use and related cognitions. The results have the potential to inform preventative interventions while addressing NIH priorities.
The objective of this trial is to test feasibility and acceptability of an e-parenting skills intervention with parents of injured adolescent alcohol users (12-17 years old) as compared to standard care at three pediatric trauma centers. To examine these questions, the investigators will randomly assign adolescent and parent dyads (up to 75) to one of two groups. One group will continue to receive the institutional standard care of a brief alcohol intervention delivered by clinical staff to the adolescent with no parenting skills intervention. The second group will continue to receive the same institutional standard care plus the parent will receive an e-parenting skills intervention consisting of: the online parent training program, Parenting Wisely(PW), plus text messaging and a web-based message board. Study participants will be injured adolescents, 12-17 years old, admitted to the inpatient service of the trauma center, and with a positive CRAFFT (mnemonic acronym of first letters of key words in the screening tool) screen for alcohol use. Adolescents' alcohol use will be measured at study enrollment and at 3 and 6 months after discharge. Adolescents' alcohol related negative consequences will be measured at study enrollment for the 6 months prior to hospitalization and again at 6 months after hospital discharge. Parenting skills will also be assessed at 3 and 6 months.
This study will help to determine whether the medication, topiramate, reduces alcohol use among adolescents with alcohol dependence. It will also help answer the question, "How does topiramate reduce drinking in teenagers?" Understanding how topiramate may reduce drinking in adolescents would allow for a more targeted pharmacotherapeutic approach to treatment and help to identify additional medications that may hold promise for improving treatment outcomes for youth.
Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use among adolescents with mild AUD in primary care settings. The study also explores the impact of these interventions on other outcomes such as substance use and psychosocial functioning, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use disorders.
The goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol.
The goal of this study is to test cannabidiol (CBD) as a potentially effective candidate medication for youth alcohol use disorder (AUD). To accomplish this goal, this study will use a randomized, double-blind, within-subjects crossover design. In counterbalanced order, 50 youth (ages 16-22) will receive 600 mg of CBD or placebo three hours before a neuroimaging and behavioral assessment paradigm. The total amount of time the participant will be in the study is approximately one month.
This is a 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). The primary efficacy endpoint is reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.
The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients.
The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).
Adolescent alcohol and other drug (AOD) use is a significant public health problem which contributes to high levels of mortality, morbidity and healthcare costs in young people, and identification and early intervention for these problems is critical to improving outcomes. Screening, Brief Intervention and Referral to Treatment (SBIRT) in pediatric primary care is an evidence-based strategy for addressing these problems, but has not been widely and systematically implemented, for a variety of reasons, including lack of training and staffing resources to support its implementation. This pragmatic, Type 1 Hybrid Comparative Effectiveness Implementation study will examine whether a centralized, virtually-delivered modality of SBIRT, rapidly accessible by multiple pediatric primary care clinics, can be cost-effectively implemented to improve early identification and treatment for AOD use and comorbid mental health problems among adolescents identified as being at high or severe risk of AOD use disorder during adolescent Well Visits.
The goal of this research study is to develop the AR-based alcohol use prevention and harm reduction intervention, "No Time Wasted", with the further aim of conducting a pre-post pilot study to assess whether the game reduce risk behaviors associated with alcohol use, whilst also increasing knowledge about some of the following topics: BAC, standard drink sizes, signs of alcohol poisoning. The intervention will also seek to encourage bystander intervention to assist fictional characters in need of help due to overdrinking.
The purpose of this project is to develop and evaluate an online mentoring and skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18, the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults (who are also mentors). TGMY will be paired with a TGM adult mentor, based on their shared interests. Mentors and mentees will participate together in each session along with other mentors and mentees. Mentors will direct activities and discussion to promote TGMY social-emotional skills. The TCP sessions will include one-on-one mentor-mentee break-out sessions.
The investigators will conduct a waitlist control trial to test the efficacy of the Journey of Transformation-Native Youth Health Leadership Program (JOT) in terms of delaying or reducing tobacco and other substance use and improving sexual health.
The overarching goal of the proposed project is to develop an innovative, online synchronous DV and AU prevention curriculum created specifically for SGMY (ages 15 to 18); conduct a pilot randomized controlled trial to assess its feasibility and acceptability of the intervention and study procedures; identify preliminary outcomes of the intervention; and ensure that the intervention is working equally well for SGMY of color.
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.
There are currently no interventions aimed at preventing both alcohol and other drug (AOD) use and interpersonal violence that have been adapted for Latino adolescents. This study hypothesizes that a cultural adaptation of a validated AOD use prevention program (Keepin' it REAL) that also integrates violence prevention content will both amplify the AOD use effects of that intervention for Latino adolescents and lead to reductions in youth violence. The purpose of this study is to conduct a pilot-test randomized controlled trial (RCT) of a youth AOD use prevention intervention that has been adapted to integrate interpersonal violence content and has been culturally adapted for a specific Latino population (Venezuelan migrant youth). The goals of the pilot test are to determine feasibility, acceptability, and preliminary effects of the intervention for future testing.
This study will be the first to explore mindfulness as a prevention intervention among transition age youth and those with previous involvement in the juvenile or criminal justice system with substance use problems and history of exposure to violence/trauma. The study will focus on preventing escalation of substance use (e.g., alcohol and marijuana), trauma symptoms, and recidivism by using an intervention to target self-regulation and executive functioning. Justice involved youth have higher rates of alcohol use and related consequences and higher rates of exposure to violence (Post Traumatic Stress Disorder) compared to their non-justice involved peers. Prior research has found aspects of self-regulation (emotion regulation, impulse control), stress, and craving to be important putative targets in reducing alcohol use. With high rates of recidivism and increased risk of long term problems associated with substance use, it is imperative to test interventions that can reach at risk youth and target both alcohol use and important psychological and neurocognitive self-regulation mechanisms. This study tests whether the use of Mindfulness-Based Relapse Prevention (MBRP) for at risk young adults results in changes in important self-regulation mechanisms and improved alcohol use outcomes. Individuals assigned to the experimental group will receive interventions normally provided at a community clinic and eight 1.5-hour group sessions of MBRP. Sessions will occur once per week. Each session will target a specific theme such as being aware of personal triggers, maintaining present focus, allowing or letting things be, responding to emotional and physical experiences in skillful ways, and recognizing intrusive thoughts. Further, each session will incorporate a mindfulness meditation technique. The central hypothesis will be tested through a focus on three specific aims: (1) Beta pilot testing and refining MBRP based on feedback from focus groups, (2) testing the efficacy of MBRP on substance use outcomes compared to an active control, and (3) assessing mechanisms of change for MBRP including self-regulation and neurocognitive facets such as working memory and inhibition.
As most adolescents visit a healthcare provider once a year, health behavior change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). Recognizing the potential to leverage recent advances in machine learning and interactive narrative environments, the investigators are now well positioned to design health behavior change systems that extend the reach of clinicians to realize significant impacts on behavior change for adolescent preventive health. The proposed project centers on the design, development, and evaluation of a clinically-integrated health behavior change system for adolescents. CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change interactive narratives that are dynamically personalized and realized in a rich narrative-centered virtual environment. CHANGEGRADIENTS will iteratively improve its behavior change models using policy gradient methods for Reinforcement Learning (RL) designed to optimize adolescents' achieved behavior change outcomes. This in turn will enable CHANGEGRADIENTS to generate more effective behavior change narratives, which will then lead to further improved behavior change outcomes. With a focus on risky behaviors and an emphasis on alcohol use, adolescents will interact with CHANGEGRADIENTS to develop an experiential understanding of the dynamics and consequences of their alcohol use decisions. The proposed project holds significant transformative potential for (1) producing theoretical and practical advances in how to realize significant impacts on adolescent health behavior change through novel interactive narrative technologies integrated with policy-based reinforcement learning, (2) devising sample-efficient policy gradient methods for RL that produce personalized behavior change experiences by integrating theoretically based models of health behavior change with data-driven models of interactive narrative generation, and (3) promoting new models for integrating personalized health behavior change technologies into clinical care that extend the effective reach of clinicians.
The primary goal of this study is to test the acceptability and feasibility of iASIST (integrated Alcohol and Suicide Intervention for Suicidal Teens), a novel adjunctive intervention for alcohol use and alcohol-related suicidal thoughts and behaviors for suicidal adolescent inpatients. The investigators will first conduct an open trial with 10 adolescents and their parents to test iASIST and make subsequent changes to the booster. Next, the investigators will conduct a randomized trial with 50 adolescents and their parents to test the feasibility and acceptability of iASIST as well as associations with alcohol- and suicide-related outcomes at 3 months post-discharge, relative to participants who receive an attention-matched comparison condition focused on the role of a healthy lifestyle in mental health that includes a post-discharge mHealth control targeting the maintenance of a healthy lifestyle.
An online, interactive web-based program for older teens and their parents is designed to address teen alcohol use and teen relationships. The parent-teen dyad both participate in the web-based program and engage in off-line discussion activities. This intervention promotes communication skills, refusal skills, and helps teens consider how to make healthy choices. A total of 411 family dyads (one parent, one teen) were recruited.
This study tests the feasibility of an intervention to prevent risky alcohol or marijuana use that adds a 4-week course of tailored text messaging to a brief motivational intervention for 13-18-year-old adolescents.