26 Clinical Trials for Various Conditions
The investigators aim to identify the frequency with which an elective brain MRI yields and etiologic diagnosis to explain its indication. The protocol includes children undergoing elective brain MRI with anesthesia prior to their third birthday.
Project MADD was designed to attempt to curb the alarming trends related to drunk driving and to move the field forward by testing a brief parent-intervention's ability to change adolescents' drinking, impaired driving, and riding with impaired driver behaviors. The aim of this project is to provide an easy-to-implement and low-cost alternative parent-based intervention that can be widely disseminated to address this important public health problem.
This project evaluates a combination of policy and social influence interventions to reduce adolescent alcohol use and its sequelae.
The purpose of the project is to assess the initial efficacy of Stepping Stones Triple P-Positive Parenting Program (SSTP) with parents of children below age two with developmental disabilities to strengthen families and prevent child maltreatment.
The Emergency Department (ED) setting is a unique point of access for reaching underage drinkers (age 14-20). With the aid of computer technology, this study will screen underage drinkers in the ED and fully test promising ED-based brief intervention and 3-month follow-up brief treatment approaches for alcohol misuse. Developing methods to efficiently and effectively optimize these approaches has powerful public health implications for improving outcomes for underage drinkers.
A randomized controlled trial (RCT) will be conducted to evaluate both the short-term and long-term efficacy of innovative, incentive-free parent-based interventions (PBIs) designed to reduce underage drinking on college campuses. Although the current NIAAA-recommended Parent Handbook has shown modest effects, our preliminary work suggests that combining personalized normative feedback (PNF) delivered through a social media-inspired app with psychoeducational content can effectively decrease alcohol-related risk. In this large, multi-site trial with 2,040 first-year students, we will examine the short- and long-term effects of the experimental app-based PNF program (PNF+ PBI) compared to an email-based social norms marketing campaign (SNMC+ PBI), the Parent Handbook (PH+ PBI), and an assessment-only control on alcohol use and consequences (primary outcomes). Parent alcohol approval and communication will also be assessed as potential mediators of intervention effects (secondary outcomes). The researchers hypothesize that students whose parents receive PNF+ and SNMC+ PBIs will report lower levels of alcohol use and fewer alcohol-related consequences compared to those whose parents receive PH+ PBI or no intervention. It is also expected that parental approval will be lower and alcohol-related communication will be higher in these two experimental conditions, relative to PH+ PBI and no intervention.
This pilot randomized controlled trial (RCT) will evaluate both the feasibility and efficacy of Digitally Prompted Parenting (DPP), a text-message based parent intervention (tm-PBI) designed to prevent and reduce alcohol use among first-year college students. In this study, parents of incoming first-year students will receive risk-reducing text messages during the first 10 weeks of the Fall semester, which they can forward to their students. The trial uses a longitudinal design to compare drinking outcomes between students whose parents receive the DPP messages and those whose parents receive an established alcohol PBI (the active control condition). The investigators hypothesize that students in the DPP group will report lower levels of alcohol use and fewer alcohol-related consequences after the intervention compared to those in the active control group.
This pilot randomized control trial (RCT) aims to assess the feasibility and efficacy of 2 College Truths \& 1 Lie (2T1L), a gamified social norms marketing campaign (SNMC) aimed at preventing and reducing first-year college student drinking. This program is designed to correct overestimations of peers' alcohol use behaviors, which, as shown in previous research, influence one's own future drinking behaviors. To examine the efficacy of 2T1L, this pilot trial will use a longitudinal design to determine whether playing 2T1L during the first few weeks of college will prevent increases in drinking or reduce subsequent alcohol use among first-year students during the same year, relative to exposure to a static social media-delivered SNMC or an assessment-only control condition. The investigators hypothesize that students randomized to receive the interactive 2T1L SNMC game will report less state psychological reactance in response to normative campus drinking statistics than students randomized to the non-gamified SNMC condition. Further, students in the 2T1L game condition will report greater accuracy in their perceptions of campus drinking norms and consume less alcohol following the six-week SNMC (short-term follow-up) and toward the end of the first year (long-term follow-up) compared to those randomized to both the active non-gamified SNMC and assessment-only control conditions.
The current project uses a web-based program called the Expectancy Challenge Alcohol Literacy Curriculum (ECALC) to reduce alcohol use and associated harms among college students. Participants complete the interactive program in 50 minutes, and then provide daily, real-time data on expectancies and alcohol use for 3 weeks after intervention, and again for one week at 13 and 25 weeks after intervention. One group will also receive biweekly boosters delivered via smart phone to assess their impact on intervention decay over time. It is hypothesized that ECALC effects may decay over time, and that biweekly boosters will prevent this decay. Access to the ECALC is available on request from the principal investigator.
College students' risky drinking and cannabis use are major public health problems. The harms associated with risky drinking have been well-documented (such as deaths, blackouts, injuries, assaults, arrests, sexual consequences, academic consequences). Both college health administrators and parents have requested electronic parent-based interventions (e-PBIs) with additional content on cannabis. Parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective e-PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the e-PBI that includes updated content including the most up-to-date scientific information from cannabis studies (e-PBI+).
The prevalence of underage alcohol use continues to be a public health concern. Numerous studies have reported associations between teen drinking tendencies and parental attitudes and beliefs, parental awareness of teen drinking, parental monitoring and the quality of the parent-teen relationship and communication. The extensive work in this area has resulted in parent-based intervention (PBI) efforts to prevent or reduce adolescent alcohol use. Several independent studies have indicated that teens whose parents received a PBI reported less alcohol use and fewer alcohol-related consequences. Despite these strengths, one major limitation of PBI is that they do not currently take into account the large role that social networking sites (SNS) use plays in adolescents' lives and in relation to their alcohol use. Most (90%) adolescents are on SNS, and their Facebook, Instagram, and Twitter profiles include alcohol content. Thus, adolescents are making and exposed to SNS alcohol displays and these displays are associated with high-risk drinking cognitions and alcohol use. As such, the investigators propose to develop and refine an interactive PBI designed to reduce high-risk SNS cognitions (i.e. attitudes and norms), alcohol use, and negative consequences among adolescents. To achieve study aims, the investigators propose an iterative process of focus groups in order to develop and refine the interactive PBI to be delivered in the pilot study with 1 and 6-month follow-up among 100 parent/teen dyads. The objective of this R34 application is to establish feasibility and acceptability of the newly developed interactive PBI that focuses on the role of SNS in adolescent alcohol use as well as to determine preliminary effect sizes for future studies. Determining an efficacious way to reduce alcohol use and high-risk alcohol display cognitions affords future research the opportunity to make use of social network-based interventions, thus the proposed research has great potential to serve as a catalyst for future research.
College students' alcohol use continues to be a major public health problem. Among the many consequences of this risky behavior are impaired driving and impaired passenger fatalities. Both college health administrators and parents have requested parent-based interventions (PBIs), and parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the PBI that includes additional content for parents to establish clear lines of communication around the important topic of permissiveness (referred to as P-Chat).
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.
The purpose of this study is to compare two versions of an intervention focused on teaching 10-14-year-old Latina/o adolescent's skills that will decrease the likelihood that they will use tobacco, alcohol, and other drugs. We are also interested in determining how cultural context is related to substance use and whether additional information about other tobacco products should be added to the GMIT intervention.
High school students' alcohol, nicotine, and marijuana use are major public health problems. Among the many consequences of these risky behaviors are impaired driving and impaired passenger fatalities as well as increased health risks. Both school administrators and parents have requested parent-based interventions (PBIs)for the general high school population that include content on alcohol, nicotine and marijuana use. In addition, digital materials are needed for the "on-the-go" parent. The proposed research will address this omission, curb the alarming trends noted above, and move the field forward by conducting a randomized controlled trial testing a modified, digital version of the Parent Handbook for the all high school students that includes additional content for parents to have broader discussions about combined alcohol nicotine and marijuana use alone (referred to as REAL Parenting). Parent-teen dyads will be invited to participate and complete baseline assessment and parents will receive the REAL Parenting or active control materials shortly afterwards. This will allow an examination of the impact of the RP on alcohol use, and associated consequences and sustained effects across the follow-up period.
While a large focus of research on U.S. college drinking has focused on the prevalence of and problems related to heavy-episodic drinking, less has focused on college students who are either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or fewer drinks per week). Over 40% percent of college students ages 18-22 do not report drinking in the past month with only half of those engaging in regular heavy-episodic drinking. Research suggests that a significant proportion of students who were abstinent or light drinkers prior to and upon entering college initiate drinking and progress to becoming heavy-episodic drinkers. This provides evidence that the first few months of college is a high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced harms throughout the college years and young adulthood. Mobile phone-based interventions are an innovative method for reaching young people and have been established as an empirical approach towards addressing health issues, including alcohol use. The ultimate goal of this proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and lighter drinking first year college students with the ultimate goal of delaying alcohol initiation and/or reducing alcohol use escalation. An iterative process of focus groups, intervention content development, and user feedback focused on the unique experiences of abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and lighter drinker college students. Given that reducing young adults' and college students' engagement in excessive alcohol use has been listed as a major objective of Healthy People 2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make important strides to achieving this goal.
This study evaluates the efficacy of the eCHECKUP TO GO as an intervention to reduce underage drinking and the associated negative consequences among high school seniors. The aim of this project is to provide a brief, low cost intervention that can be easily disseminated as a school-based intervention to address this important public health problem.
The goal of this research program is to implement and evaluate complementary interventions designed to address underage alcohol, marijuana, tobacco and other drug use and abuse among Native American youth residing in and around nine contiguous Indian reservations in rural portions of a Southern California county. Component 1. Motivational Interviewing (MI) Evaluations (Identified PHI). Approximately 150 participants between 13 and 20 years of age will participate in the Motivational Interviewing (MI) intervention and one follow-up assessment over an 18 month period. Questionnaires of youth substance use and access patterns will be by phone or self-administered using paper, iPad, and web-based surveys. Formal informed consent from participants 18 and older and assent and parental/legal guardian consent will be obtained from those participants under 18. Component 2. Psychoeducation (PE) Evaluations (Identified PHI). Approximately 150 participants between 13 and 20 years of age will participate in the Psychoeducation (PE) intervention and one follow-up assessment over an 18 month period. Questionnaires of youth substance use and access patterns will be by phone or self-administered using paper, iPad, and web-based surveys. Formal informed consent from participants 18 and older and assent and parental/legal guardian consent will be obtained from those participants under 18.
This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.
This present multi-site investigation compares a voluntary brief intervention for adolescent alcohol problems to an educational comparison condition. Measures are taken at intake and at 4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal change efforts and arrest progression of alcohol problems. This study tests cognitive mechanisms of change and treatment characteristics and processes associated with youth self-regulation to reduce or stop hazardous drinking.
A multi-center human factors validation study to demonstrate the function of the IKE Bluetooth system on a chip (SoC) and mobile applications ability to age-gate a device, accurately identify an individuals age, race/ethnicity, and gender, and asses the usability of the IKE System.
Personalized Normative Feedback (PNF), the most widely-used college alcohol intervention approach, suffers from several limitations innovatively remedied in the current proposal through CampusGANDR, a smartphone-based app for college students that delivers alcohol-related PNF within a weekly game centered around testing first-year students' perceptions about the attitudes and behaviors of their peers in a variety of campus-relevant domains. Five pilot studies suggest that CampusGANDR will be significantly more effective at correcting students' normative misperceptions and reducing their alcohol use than standard PNF, especially among heavier-drinking students and those with greater exposure to alcohol on social media, and that these larger effects are driven by the significantly decreased psychological reactance experienced by students when viewing feedback as part of a game about college life rather than as part of an alcohol-focused program. The current project seeks to 1) evaluate the efficacy of CampusGANDR in a large-scale multi-site trial, 2) identify the optimal dosage of alcohol feedback to deliver within CampusGANDR for correcting norms and reducing alcohol use across 12 weeks of gameplay among non-drinking, moderate-drinking, and heavy-drinking students, 3) examine person-level moderators of these effects, and 4) evaluate CampusGANDR engagement and sustainability among students who play voluntarily but are not involved in the randomized controlled trial.
The current study aims to test the efficacy of a family communication-based, novel, adaptable, and resource-efficient substance misuse preventive intervention for parents/guardians of pre/early adolescents (grades 5-7). The short-term goal of this study is to increase the quality time that parents spend with their children through eating meals together, and in so doing, talking about the harms associated with substance use (intermediate endpoint), which will in turn, lead to the long-term goal of preventing the initiation and misuse of substances among their children as they enter adolescence.
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.
This randomized controlled trial (RCT) study is a small scale test of the feasibility and preliminary efficacy of a brief motivational interview-style intervention. The intervention took place in the pediatric emergency departments by a trained interventionist and will followed an intervention algorithm developed by a team of dating abuse and brief intervention experts. The research design is as follows: the investigators will randomize youth ages 12-19 years old to one of two groups: one group who receives the intervention (N=\~18), and the other which does not (N=\~18). The investigators compared changes in outcomes from baseline to 1-month follow-up for those in both groups. The investigators looked at outcomes including dating abuse-related knowledge, attitudes about the use of violence to resolve conflict, and dating abuse behavior (perpetration and/or victimization). Statement of study hypothesis: Youth who receive the intervention will show improvements in dating abuse-related knowledge, attitudes and behavior that are maintained for 1 month, while those in the comparison group will show no similar change.
The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).