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71 Risky Behaviors Trials Near You

Power is an online platform that helps thousands of Risky Behaviors patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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No Placebo
Highly Paid
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Pivotal Trials (Near Approval)
Breakthrough Medication
This study evaluates knowledge, feelings and thoughts regarding nicotine products among young adults who are susceptible to but do not use tobacco/nicotine and adults who use tobacco/nicotine.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65

450 Participants Needed

Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 24

300 Participants Needed

The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

144 Participants Needed

Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use. A mobile app has been developed that uses GPS tracking to determine when individuals visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location. The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("TRAC-ER") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 35

405 Participants Needed

The opioid epidemic has become one of America's deadliest crises, surpassing car crashes, firearms, and HIV/AIDS as a leading cause of death for Americans under fifty years of age. People trying to recover from opioid-use disorder face many obstacles. Obstacles such as minor legal problems (e.g., arrest warrants for failure to pay a fine, failure to appear in court, or late child support payments) can undermine the stability needed to overcome opioid dependence. Outstanding legal obligations make it difficult to find jobs and to secure housing. They can result in removal from treatment programs as well as incarceration. Resolving these legal problems requires coordination, organization, preparation, travel, and time-expectations that may be problematic for many people in the early stages of recovery. Technology has the potential to make resolving these legal problems much easier. Online platform technology is now available that can guide people in recovery through the resolution of many legal problems at no cost and without an attorney, potentially doing so quickly, remotely, and at any time of day. This study of individuals in treatment in Michigan tests whether resolving outstanding legal issues improves drug treatment outcomes. The research also examines whether and to what extent resolving legal issues supports family reunification, reduces future criminal behavior, and improves access to jobs and housing for clients in treatment for opioid use disorder. A randomized controlled trial (RCT) is used to determine the effects of resolving legal issues on these outcomes. For identification, the investigators leverage the random assignment of legal services to treatment center clients, along with the random assignment of clients to treatment centers by birth month. We assemble a novel longitudinal dataset of hundreds of clients in treatment for substance use disorder and link these clients to several administrative datasets and qualitative data, which allows for measurement of: (1) substance use behaviors and (2) justice-system involvement, including civil and criminal legal system encounters. This study also uses linked client and administrative data to research the population in opioid treatment centers, follow-up behaviors, and whether the consequences of providing no-cost legal services differ by client background. Findings from this research will improve America's understanding of the acute socio-legal needs faced by those experiencing opioid use disorder and provide recommendations to help target resources toward the areas that best support long-term abstinence from opioids and other drugs.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

800 Participants Needed

This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are: 1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence. 2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users. 3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

120 Participants Needed

Floreciendo is a sexual and reproductive health workshop for Latina teens (ages 14-18 years) and their female caregivers (e.g., mothers, sisters, grandmothers). This study involves conducting a pilot optimization trial of Floreciendo using the multiphase optimization strategy (MOST) framework. The feasibility of using a 2 x 2 x 2 factorial trial design and the acceptability of the intervention components of Floreciendo will be examined. Effectiveness and implementation outcomes will be explored. This work will be conducted in partnership with community-based organizations in the Chicagoland area.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:14+

184 Participants Needed

This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:12+

1440 Participants Needed

This study will test the effectiveness of different types of driver training interventions for reducing young new driver crash risk early after licensure.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 17

1300 Participants Needed

The current study proposes to develop, refine, and conduct a preliminary randomized controlled trial (RCT) of an innovative prevention program that is the first to (a) simultaneously target heavy episodic drinking (HED), sexually aggressive behavior (SAB), and risky sexual behavior (RSB) among college men; (b) integrate personalized feedback and cognitive training strategies; and (c) target the five major modifiable risk factors for SAB: HED, impersonal sex, misperceptions of sexual interest, rape-supportive attitudes, and peer influence. The program will be computer-delivered as this approach is well received by college students.
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:18 - 19
Sex:Male

190 Participants Needed

The purpose of this study is to evaluate a Female-Specific Cognitive Behavioral Therapy (CBT) Group as treatment for Alcohol Use Disorder among Veteran women.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

162 Participants Needed

Women in the criminal legal system are more likely to experience substance use disorders and unintended pregnancy than women in the general public. However, they often face barriers to accessing substance use treatment and sexual and reproductive health services. This study tests the feasibility and acceptability of Women on the Road to Health (WORTH) Promoting Access to Treatment, Health, and Support (Paths), a digital intervention adapted from the evidence-based CDC Best Practice HIV prevention intervention, Women on the Road to Health (WORTH), originally developed at Columbia University School of Social Work. WORTH Paths is designed to help reproductive-aged women in the criminal legal system with substance use disorders and unmet need for contraception reduce drug use and improve contraceptive use. Participants (N=50) will be randomly assigned to one of two groups: WORTH Paths Intervention Group - Participants will attend three virtual group sessions with facilitated videoconference sessions and self-paced digital activities focused on reducing drug use and increasing contraceptive use. They will also receive guidance on how to access and navigate health services. Control Group - Participants will receive a virtual general wellness program that includes education on substance use and sexual and reproductive health but does not include skills-based training related to these topics. The focus will be on general wellness and stress reduction. Both groups will receive resources for substance use treatment and sexual and reproductive health services. Researchers will track changes in drug use and contraceptive use over three months. Participants will complete surveys and provide urine samples to confirm changes in drug use. Primary aims: Feasibility: Measured by session attendance, treatment completion, dropouts, and reasons for termination. Acceptability: Measured by participant ease of use, helpfulness, and satisfaction. Primary behavioral outcomes: Self-reported drug use confirmed by urine drug tests. Contraceptive use, including initiation and consistent use. Secondary behavioral outcome: Linkage to substance use disorder treatment (measured by appointments made and sessions attended).
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 44
Sex:Female

50 Participants Needed

This study addresses the need for HIV prevention to be integrated into contraceptive counseling visits at family planning clinics.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female

50 Participants Needed

Alzheimer's Disease (AD) and other Dementias have far-reaching consequences on the lives of sufferers and their loved ones, not to mention the impact on the healthcare system. Several studies have identified protective lifestyle habits that might help reduce the risk of cognitive decline: cognitive engagement, physical activity, and a healthy diet. Our aim is to determine the efficacy of the Luci program, an online, coach-assisted, multidomain, behavioural intervention designed to help middle-aged to older adults reduce their risk of dementia by improving their lifestyle habits. In this study, we hope to demonstrate that participating in the Luci program helps to improve lifestyle habits and that the program could therefore become an effective health promotion tool.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:50 - 75

370 Participants Needed

Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children. The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called CASA (Comunidad, Alimentacion, Seguridad y Amen). Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (the CASA) in collaboration with Hispanic churches and their congregants. SA2. To conduct the CASA intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention. SA3. To assess the impact of the CASA intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child). The investigators will compare between the intervention group (16 mother-child dyads) versus the control/attention group (16 mother-child dyad) to see if the intervention is effective in improving diet quality and changing cooking behaviors. Participants will: 1. Participate in cooking workshops and one to one learning activities 2. Report on diet and physical activity 3. Will measure fruit and vegetable intake
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:7+

64 Participants Needed

The number of women who are incarcerated in the U.S. has increased dramatically over the past 20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas incarcerates 92 women per 100,000 population compared to 57 per 100,000 average across all states, ranking the state as the 8th highest in the nation. Over 75% of incarcerated women are of childbearing age and about 4% are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas from June 1, 2014 to May 31, 2019 (a five-year cohort; Aim 1). Then, we will lay the groundwork for and subsequently analyze data on outcomes and perspectives of women who have been incarcerated in Arkansas while pregnant (Aims 2 and 3). We will also seek to understand the feasibility and acceptability of elements of an enhanced support program for incarcerated pregnant women recently launched via a collaboration between Arkansas Department of Corrections and UAMS.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

10 Participants Needed

The goal of this clinical trial is to establish whether brief interventions for alcohol use can be delivered in schools for both indicated prevention and selected prevention, determine if an expanded workforce is an effective model for screening, brief intervention, and referral to treatment (SBIRT) delivery in schools, and explore whether brief intervention effectiveness is comparable in minoritized versus non-minoritized adolescents. Participants will be students at high schools across Massachusetts. High schools will be randomized to one of four intervention groups. Participants will complete a baseline survey prior to their school-wide screening for SBIRT, and then will complete four follow-up surveys over two years.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:14 - 19

18000 Participants Needed

The most successful young adult alcohol or marijuana interventions involve the provision of accurate, nonjudgmental personalized feedback, but notably the inclusion and effectiveness of protective behavioral strategies (PBS) content is inconsistent. Moreover, active components of brief interventions are not well understood, and findings have been inconclusive regarding whether PBS mediates intervention efficacy of college student personalized feedback interventions (PFIs), with only some studies showing evidence of mediation. One possible reason for these findings is that investigators often do not know young adults' motivations for using (or not using) PBS or the quality of PBS use across individuals or across drinking occasions. The proposed study will provide an in-depth examination of which PBS young adults are motivated to use (including implementation quality) and reasons that young adults may or may not use PBS. Understanding why young adults are choosing not to use PBS on specific occasions or do not engage in effective or high-quality PBS use on certain occasions has significant clinical implications, whereby interventions may need to spend more time increasing motivations to use PBS in an effective manner or work on reducing perceived barriers (i.e., reasons individuals are not using PBS). Clinicians may then be better able to work with young adults in various settings to reduce or prevent excessive alcohol and marijuana use and related consequences. The proposed research has high potential for making a substantial impact on the field and public health (particularly as more states permit legal access to marijuana for those over 21) as it will address a problem of high importance (alcohol and marijuana use) by being the first to develop and refine a PBS intervention that specifically focuses on motivations for alcohol and marijuana PBS use and non-use as well as quality of use, which is an overlooked aspect of current PBS-related intervention approaches. The development of more efficacious interventions to reduce the proportion of young adults who engage in excessive alcohol use and who experience consequences is a key priority of the NIAAA. Related, development of more effective interventions to reduce risk from marijuana use is an area of great importance for the NIDA.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:18 - 24

162 Participants Needed

The goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. The primary research question it aims to answer is: (RQ1a): What is the effect of adding 4.5 hours of Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 9th and 10th graders compared to the students receiving only the 14-hour-long Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the 14-hour-long Relationship Smarts Plus curriculum on rates of unprotected sex among 9th and 10th graders compared to the control group receiving only financial literacy? Participants will complete program lessons and complete surveys for data collection. The RCT will assess behavioral health outcomes and other psychological outcomes at four-time points (baseline, post-program, 3 months, and 12 months)
No Placebo Group

Trial Details

Trial Status:Recruiting

2250 Participants Needed

VIP Program for Risky Behaviors

Coral Gables, Florida
The purpose of this study is to review and assess the usefulness of the Values in Perspective (VIP) program to avoid adolescent risky behaviors.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:10 - 17

150 Participants Needed

Why Other Patients Applied

"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

WR
Obesity PatientAge: 58

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

ZS
Depression PatientAge: 51

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40
This study will implement and evaluate a mentoring program designed to promote positive youth development and reduce adverse outcomes among maltreated adolescents with open child welfare cases. Teenagers who have been maltreated are at heightened risk for involvement in delinquency, substance use, and educational failure as a result of disrupted attachments with caregivers and exposure to violence within their homes and communities. Although youth mentoring is a widely used prevention approach nationally, it has not been rigorously studied for its effects in preventing these adverse outcomes among maltreated youth involved in the child welfare system. This randomized controlled trial will permit us to implement and evaluate the Fostering Healthy Futures for Teens (FHF-T) program, which will use mentoring and skills training within an innovative positive youth development (PYD) framework to promote adaptive functioning and prevent adverse outcomes. Graduate student mentors will deliver 9 months of prevention programming in teenagers' homes and communities. Mentors will focus on helping youth set and reach goals that will improve their functioning in five targeted "REACH" domains: Relationships, Education, Activities, Career, and Health. In reaching those goals, mentors will help youth build social-emotional skills associated with preventing adverse outcomes (e.g., emotion regulation, communication, problem solving). The randomized controlled trial will enroll 234 racially and ethnically diverse 8th and 9th grade youth (117 intervention, 117 control), who will provide data at baseline prior to randomization, immediately post-program and 15 months post program follow-up. The aims of the study include testing the efficacy of FHF-T for high-risk 8th and 9th graders in preventing adverse outcomes and examining whether better functioning in positive youth development domains mediates intervention effects. It is hypothesized that youth randomly assigned to the FHF-T prevention condition, relative to youth assigned to the control condition, will evidence better functioning on indices of positive youth development in the REACH domains leading to better long-term outcomes, including adaptive functioning, high school graduation, career attainment/employment, healthy relationships, and quality of life.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:13 - 16

234 Participants Needed

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 14

120 Participants Needed

The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:10+

52323 Participants Needed

Suicide is the second leading cause of death among young people aged 12-17 years in the United States, yet many youth at risk for suicide are not identified or go untreated. Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics. Clinical pathways are tools used by health professionals to guide evidence-informed practice. The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up transitional care. STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model (PRISM), which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability. The main questions the study aims to answer are: * Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline (primary outcome)? * Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury, and improving family satisfaction at 12 months post-baseline (secondary outcomes)? * What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC?
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 17

5244 Participants Needed

This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women. A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric. Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:45 - 64
Sex:Female

64 Participants Needed

The goal of this randomized controlled study is to learn if, in addition to nurses, community members can be trained as health coaches to deliver the HealthyLifetime (HL) program to people without complex chronic health conditions, an intervention that provides a short-term and effective health coaching intervention delivered through a virtual platform to improve health, resiliency, and independent self-care to participants who are without complex chronic conditions. The main question it aims to answer is: • Can Community Health Coaches achieve the same level of competency and outcome as Nurse Health Coaches in participants without complex chronic conditions?
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:30+

300 Participants Needed

This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:25 - 55

69 Participants Needed

The investigators hope to develop a treatment for suicidal ideation (SI), impulsivity and functional impairments (such as difficulties in social and work settings) that occur after a mild traumatic brain injury (mTBI). These conditions have been shown to be linked. The investigators are using a high-powered magnetic pulse, called intermittent theta burst stimulation (iTBS) applied to the head to see if it can improve these symptoms. The high-powered magnetic pulse causes certain cells in the brain to activate, which seems to strengthen connections between parts of the brain. The purpose of this research is to gather early information on the safety and effectiveness of iTBS provided to the front of the head for impulsivity, SI and functional deficits after mTBI. The investigators plan to use the data collected in this study to develop larger studies in the future. iTBS is FDA approved, but not for these specific symptoms, or in the specific location the investigators are placing it. The investigators are testing to see if its effective for the above conditions when applied to the front of the head.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1
Age:22 - 65

55 Participants Needed

The principal objective of Tennessee Youth Prepared for Success is to pilot, implement, and test innovative adolescent pregnancy prevention strategies using a randomized controlled trial (RCT) to effectively educate youth on both abstinence and contraception with the goal of reducing youth pregnancies, births, and STIs. Tennessee Youth Prepared for Success will address Adulthood Preparation Subjects (APS) to promote youths' successful and healthy transition to adulthood; include a Positive Youth Development (PYD) approach to engage youth and provide positive influences and skill building opportunities; and implement activities/interventions within a trauma-informed approach to account for the mental health needs of those who have experienced maltreatment, abuse, or violence. The project's goals and principal and subordinate objectives align with the PREIS program's goals/objectives and purpose, including (1) targeting high-risk youth to prevent pregnancy and STIs, including HIV/AIDS; (2) rigorously evaluating interventions using an RCT; (3) manualizing/packaging curriculum; and (4) disseminating lessons learned, best practices, and relevant findings. Tennessee Youth Prepared for Success will serve 1,200 youth ages 14-19 in 9 primarily rural counties in East/Middle/West Tennessee, targeting high-risk/vulnerable youth, including rural youth, those residing in counties with high teen birth rates, and/or hard-to-reach youth (e.g., systems-involved).
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 19

1200 Participants Needed

This study consists of three aims focused on examining the feasibility of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) to improve patient and caregiver outcomes and reduce hospitalizations in older adults with complex health needs. The objectives are to: 1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms 2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants 3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:65+

110 Participants Needed

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Frequently Asked Questions

How much do Risky Behaviors clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Risky Behaviors clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Risky Behaviors trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Risky Behaviors is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Risky Behaviors medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Risky Behaviors clinical trials?

Most recently, we added Cognitive Behavioral Therapy for Chronic Pain, PrEP Counseling for HIV Prevention and Transcranial Direct Current Stimulation for Dementia to the Power online platform.

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