549 Clinical Trials for Various Conditions
This application requests funding to conduct a randomized effectiveness trial of The New Beginnings Program (NBP) delivered through a partnership of domestic relations courts, community service providers and the NBP research team. This is the first attempt to offer the population of families seeking divorce an evidence-based prevention program shown to have long-term effects on youth problem outcomes. It is estimated that over a third of U.S. children experience parental divorce, which confers elevated risk for multiple problems in childhood and adulthood including substance use and abuse, smoking, mental health problems, high risk sexual behavior, and physical health problems. Efficacy trials of the NBP found positive effects at post-test, 6-year and 15-year follow-ups. For example, at 6-year follow-up the participation in NBP led to reductions in marijuana, drug and alcohol use and a 37% reduction in prevalence of diagnosed mental disorder; and reductions in externalizing problems, internalizing problems and high risk sexual behavior. Positive effects also occurred for grade point average (GPA) and self esteem. For many of the effects of the NBP, the effects were stronger for youth who were at higher risk at program entry. Many of the program effects were mediated through the program effects to strengthen parenting. Funded by an Advanced Center for Intervention and Services Research grant (NIMH P30 MH068685) the investigators modified the NBP to translate it from a prototype tested in efficacy trials into a program that can be effectively delivered by community service providers and one that is appropriate across diverse cultural groups, and fathers as well as mothers. Pilot testing of the modified NBP and training and monitoring systems has demonstrated that they are highly acceptable to parents and providers. The investigators also developed and experimentally tested a system of parent recruitment that was found to be effective in getting parents to enroll (sign up to participate) in the NBP but, similar to other prevention parenting programs, initiation (attendance at one or more sessions) in the NBP in the pilot was low.
Divorce, Drug Abuse, Mental Health Disorder
Clinical study participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future substance abuse disorder patients during clinical trials.
Substance Abuse Disorder
The study will use focus group methodology in the formative evaluation phase. Focus group methodology provides a rich source of data and understanding of phenomena by allowing the researcher to examine the interaction among participants
HIV/AIDS
An experiment to test the effectiveness of providing monetary bonuses to staff for achieving pre-defined performance targets regarding the implementation of a motivational interviewing-based brief intervention for substance use.
Substance Use
The purpose of this study is to estimate the observed incidence of the health outcomes (suicide attempt or ideation, suicide ideation, suicide attempt, psychosis, and substance abuse) in a cohort of participants diagnosed with attention deficit hyperactivity disorder (ADHD) who are first-line new therapy with methylphenidate monotherapy, lisdexamfetamine monotherapy, atomoxetine monotherapy, amphetamine/dextroamphetamine combo therapy, and either methylphenidate/lisdexamfetamine/atomoxetine monotherapy or amphetamine/dextroamphetamine combo therapy during the 'on treatment' period from 7 days after the start of exposure through the end of exposure (treatment discontinuation for at least 60 days) and the 'intent to treat' period from 7 days after start of treatment to end of continuous observation; and to compare the hazards of outcomes (suicide attempt or ideation, suicide ideation, suicide attempt, psychosis, and substance abuse) in the target cohort (participants diagnosed with ADHD who are first-line monotherapy new users of methylphenidate) versus each comparator cohort (patients diagnosed with ADHD who are first-line newly exposed to lisdexamfetamine monotherapy, atomoxetine monotherapy, amphetamine/dextroamphetamine combo therapy) during the 'on treatment' period from 7 days after the start of exposure through the end of exposure (treatment discontinuation for at least 60 days) and the 'intent to treat' period from 7 days after start of treatment to end of continuous observation.
Attention Deficit Disorder With Hyperactivity
The main aim of this formative study is to test and iteratively refine a new mobile phone app, which delivers assessments and tailored intervention content. The study will use social media advertisements to recruit a total of 40 youth between the ages of 16-24 years. Those screening positive for past-month binge drinking or marijuana use will be invited to complete a baseline survey, download and use the app for 30 days, and complete a follow-up survey about the app functionality, design and content, and preliminary outcomes (intentions and importance of reducing use).
Substance Use
YMHP is a counseling intervention program for which the goals are to better understand HIV-prevention focused self-management behaviors among HIV-negative YMSM, and to study the implementation of YMHP to improve portability and scalability. The clinic sites will help investigators to assess and address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce HIV infection among YMSM that reflects the complexities of real world adolescent HIV clinics.
HIV Infections
The aim of this study is to evaluate the efficacy of engagement strategies for increasing daily data collection adherence among substance-using youth between the ages of 14 and 24. The primary hypotheses of this study are that: (1) receiving a reinforcer after completing daily data collection activities will predict next-day completion of targeted data collection activities; and (2) receiving a notification prior to 6pm (when data collection activities open) will predict same-day completion of data collection activities.
Substance Use
The ultimate goal of this research is to facilitate rapid enhancement of youth substance abuse treatments by determining the key mechanisms of change (i.e., what to target more intensely to generate better outcomes). This work is critical because current outpatient adolescent substance abuse treatments yield only small to medium effects that diminish once treatment has ended. The proposed modern mediation study will address this serious public health problem by experimentally evaluating the most critical factors causing change in client outcomes during adolescent substance abuse treatment, directing the field to focus treatment efforts on those factors.
Substance Use Disorders
This project will develop and pilot test an enhanced, telephone "coaching" intervention to help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to seek treatment for a substance abuse problem.
Substance Abuse
Sharp increases in substance use rates among youth in Mexico are a major concern, both in Mexico and the US. Although the Mexican government has elevated substance abuse prevention as a national priority, there are few school-based universal prevention programs to choose from that are culturally grounded, empirically tested, and shown to be efficacious. This study aims to address this gap by adapting, implementing, and testing the keepin' it REAL (kiR) prevention intervention in Mexico's three largest cities: Mexico City, Guadalajara, and Monterrey. kiR is a model program for middle school students on the US National Registry of Effective Programs and Practices, shown to be efficacious and cost-effective in reducing substance use among large multi-ethnic and Mexican American samples in the US. The proposed study will leverage the bi-national research team's expertise in developing and adapting kiR and build upon a series of feasibility studies across Mexico which showed that kiR's core elements are applicable there. However, evidence also suggested that further adaptation is needed to enhance the intervention's cultural fit. During the proposed study's Phase 1, students and teacher-implementers in three schools-one from each of the cities-will provide feedback about the original curriculum and identify culturally and contextually relevant scenarios and examples. The bi-national research team-including original kiR curriculum designers-will collaborate to ensure cultural applicability in Mexico and fidelity to core elements of kiR. In Phase 2, the efficacy of the culturally adapted Mexican version of kiR, relative to the original version of kiR and to a control condition, will be tested through an intent-to-treat analysis in a randomized controlled trial with 7,768 7th grade students in 36 middle schools, 12 from each city. The study will investigate and incorporate into the curriculum gender specific experiences with drug offers and appropriate drug resistance strategies in the Mexican context that may impact the youths' risk of substance use and their responsiveness to prevention programs. In light of rising violence in Mexico, a secondary aim of the study is to investigate how youths' perpetration, victimization, and witnessing of violence may moderate the efficacy of kiR in Mexico. The study will create knowledge relevant to efficacious prevention approaches for Mexican-heritage youth on both sides of the US-Mexico border. Prevention science will be advanced by understanding how culturally influenced gender norms affect substance use offers, attitudes, and behaviors, as well as the success of universal prevention programs. In addition, the study will add to knowledge on how to execute collaborative, cross-national, translational prevention intervention research.
Substance Use
A cluster randomized experiment focused on testing the extent to which the organization-focused Implementation \& Sustainment Facilitation (ISF) strategy is an effective adjunct to the staff-focused Addiction Technology Transfer Center (ATTC) strategy.
Substance Use
The pilot test of Centervention-ATOD, a customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings, will evaluate whether the product awards additive benefits in provider implementation proficiency and efficacy, quality of implementation delivery, and EBP (i.e., Free Talk or CHOICE) outcomes compared to traditional implementation methods. Additionally, a cost-effectiveness study will be conducted to assess whether the implementation support strategy (i.e., Centervention-ATOD) is more cost-effective than traditional implementation methods.
Substance Abuse
This is a pilot study of the feasibility of the virtually reality, online, culturally grounded HIV prevention intervention for Native American men who have sex with men. The project will include 90 Native American men who have sex with men (MSM) from across the continental United States as well as Alaska and Hawaii. The investigators will use a randomized clinical trial with a waitlist control condition to evaluate the intervention's impact on HIV / Sexually Transmitted Infections (STI) testing behavior, condom use, and substance use harm reduction. Specifically, investigators will ask participants to spend 3 weeks exploring a virtual reality environment hosted in the Second Life® platform. The island consists of 3 levels: Learning Level, Skills building level, and Experiential level. In the Learning level the participant's avatar will have the opportunity to attend up to 2 free Motivational Interviewing sessions to establish their goals for their time on the island. Additionally, they will explore 4 learning paths each covering a knowledge objective: HIV Testing, Condom Use \& Condom Use Negotiation, Safer Sex, and Harm Reduction. Each path will present knowledge via videos, interactive games, stories, and teachings. After completing level 1, participants will move on to the Skills building level. Here participants will have the opportunity to role play scenarios (e.g., obtaining an HIV test, requesting PrEP from their doctor, negotiating condom use) with pre-program virtual actors. All scenarios are based on the knowledge gained in the Learning Level. Participants will also engage on mini-quests for additional knowledge and in-world rewards. Finally, in the third level participants will be able to practice the skills learned in interactions with other participants' avatars. If efficacious, this online HIV prevention intervention has the potential for widespread dissemination and could be particularly helpful for rural and reservation-based Native MSM who often have difficulty accessing services and support.
HIV, Substance Use
This study's purpose is to examine the effectiveness of a promising intervention for emerging adults (EAs) with alcohol and other drug (AOD) abuse and justice involvement in achieving the ultimate outcome of reduced criminal activity. The study will also examine that effect on intermediate outcomes as follows: 1) reduced AOD use; 2) greater gainful activity (increased educational success, employment and housing stability; decreased antisocial peer involvement and relationship conflict); 3) and greater improvement in self-regulation (self-efficacy, goal directedness and responsibility taking). The intervention to be tested is Multisystemic Therapy-Emerging Adults (MST-EA). MST-EA is an adaptation of MST, a well-established, effective intervention for antisocial behavior in adolescents.
Antisocial Behavior
The proposed stage 1 intervention development study is designed to address two significant co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce family violence because SA treatment alone does not result in an end to these behaviors. Currently available interventions have had little success in reducing male IPV. Fathers for Change, an integrated outpatient intervention, shows promise as an intervention model targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers as a motivation for change and targets factors that are known to trigger SA, IPV and CM: hostile cognitions and poor emotion regulation. An intervention of this sort has not been integrated and tested as part of a residential substance abuse program for men. This project is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed by comparing it to PE in the areas of: participant completion rates, hostile cognitions, emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in hostile cognitions and emotion regulation will be examined as the mechanisms through which Fathers for Change reduces relapse, IPV and CM risk behaviors.
Intimate Partner Violence, Substance Abuse/Addiction, Child Maltreatment
The co-occurrence of child maltreatment and parental substance-use problems is a major public health problem with serious consequences for children, parents, families, and the community at large. The need for effective dual treatment of caregiver substance abuse and child maltreatment is unquestionable, but there is a dearth of controlled treatment outcome studies with substance-using parents who have engaged in child maltreatment. This project examines two evidence-based treatments-Contingency Management for substance-use problems and Pathways Triple P parenting intervention to improve parenting for prevention of child-maltreatment recurrence. These two systematic interventions are being tested in the context of traditional outpatient treatment for substance-use problems.
Substance Use, Child Maltreatment
The purpose of this study is to determine if a new substance use prevention curriculum for rural middle schools is effective in reducing substance use and to study how prevention curriculum get implemented by teachers.
Substance Abuse Problem
This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (PHASE 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services.
Substance Use Disorders
The purpose of the study is to determine the safety and efficacy of an integrated treatment for substance abuse and posttraumatic stress disorder for young adults. The integrated treatment includes two established psychosocial treatments for substance abuse (Contingency Management) and posttraumatic stress disorder (Prolonged Exposure therapy).
Substance Use Disorder, Posttraumatic Stress Disorder
Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase treatment to opiate dependent patients with mental illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes buprenorphine to track the success of buprenorphine for the maintenance of opiate dependence.
Opioid-related Disorders, HIV Infections, Hepatitis C, Chronic, Depression
This is a randomized trial of two group-based models of care for buprenorphine/naloxone (bup/nx) patients in Substance Use (SU) specialty treatment: Standard Medical Management (SMM) and Intensive Outpatient Treatment (IOT). The setting is a large outpatient SU treatment program, where a medical management model of care has not been empirically tested with bup/nx patients, and where a high prevalence of patients with co-occurring psychiatric and medical co-morbidities are treated. SSM includes brief weekly group-based visits consistent with previously studied medical models, and is drawn from primary care bup/nx research. IOT is a predominant model of care in specialty treatment, and incorporates psychosocial support, 12-step, educational and relapse-prevention based approaches. The investigators will recruit 300 adult patients inducted onto bup/nx, randomize them to either SMM or IOT, and conduct telephone follow-up interviews at 6 and 12 months. Study investigators will examine the impact of these treatment approaches on 90-day bup/nx adherence, opioid and SU abstinence, quality of life, and health care and societal costs. Further, investigators will examine whether the effect of IOT versus SMM on adherence and SU treatment outcomes is greater for those with medical or psychiatric co-morbidities. This innovative approach includes a focus on complex patients with psychiatric and medical co-morbidities in specialty care, adapting a care model previously only tested in primary care, a 12-month follow-up, no research-forced medication taper, an examination of health care and societal costs, and a combination of patient self-report and electronic medical record data. Through this approach, the proposed study will yield critically important findings on how best to treat complex prescription opioid dependent patients with an integrative behavioral services and medication treatment model in SU treatment.
Opiate Substitution Treatment
To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings.
Substance Use
The prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys. Less is known about the rates for specific comorbid conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse, bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The effects that different demographic characteristics (ethnic background, family medical history, age, living conditions \[e.g., living with a single parent\]) have on the prevalence of comorbid mental illness and substance abuse also have not been considered. More should be known about the duration of substance abuse in different mental illnesses among those undergoing treatment, and whether specific types of drugs are associated with specific mental illnesses. In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence rates for the specific comorbid conditions and demographic relationships described above. This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from 1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV (The Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders). The samples will be analyzed for both prescription drug compliance and illicit substance abuse. Urine or oral fluid samples will be collected at three time points: 1) immediately after enrollment and obtaining informed consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the study (6 months).
Schizophrenia, Drug Abuse, Anxiety Disorder, Bipolar Disorder, Major Depression
The purpose of this project is to develop and test a Home-based Continuing Care intervention that will help parents support the recovery of their Young Adult (YA) child who is leaving residential substance abuse treatment. The two phase pilot study will 1) interview 50 parents and 50 YAs recruited from residential treatment programs and from parent groups to inform the development of the intervention and 2) conduct a two-arm pilot study that will recruit a maximum of 20 parents and their young adult children into one of two conditions (Home-based Continuing Care \[HCC\] intervention group or Services as Usual \[SAU\] comparison group) with the main goal of determining whether conducting such an intervention is acceptable and sustainable, and to collect preliminary efficacy data. We hypothesize that pilot testing will indicate that: (a) HCC is acceptable and potentially sustainable; (b) conducting a randomized clinical trial is feasible, and (c) the magnitude of outcomes from HCC will be clinically meaningful.
Substance Use Disorders
This two-phased project will develop a comprehensive, audio computer assisted self-administered interview social harm questionnaire (ACASI-SHQ) that will allow researchers to more easily identify and monitor social harms experienced by substance abusers participating in HIV-related trials. The ACASI-SHQ will (1) reduce the likelihood of socially desirable responding, (2) include items with high levels of specificity to increase the likelihood of identifying social harms (construct validity), and (3) utilize a self-interview format that will increase the likelihood of its adoption by HIV researchers. The investigators will then evaluate its feasibility, acceptability, and preliminary utility and construct validity in an ongoing HIV-related trial.
Social Harms in Substance Users in HIV Trials, Audio Computer Assisted Self-administered Questionnaire
This study aims to address a serious public health problem (i.e., substance abusing adolescents) by testing the effectiveness of a promising substance abuse treatment implemented in a community-based treatment setting (CM-FAM, a family-based contingency management intervention) in comparison to usual treatment services.
Substance Abuse, Delinquency, Mental Health
Medication adherence rates among youth living with HIV are inadequate to effectively manage the disease, and novel interventions grounded in basic behavioral sciences are needed. This multi-site phased (3 phases) study plans to translate basic cognitive neuroscience regarding prospective memory (PM) into a more potent adherence intervention for youth living with HIV (YLH). The phases are: Phase 1: To improve PM in basic laboratory tasks in YLH with and without substance abuse. -Hypothesis 1: Manipulations in three theory-based components of PM (strategic encoding, self-monitoring and cue salience) will improve PM within each participant. Phase 2: To conduct proof of concept studies of a text-delivered PM intervention for taking ART in YLH with suboptimal adherence. * Hypothesis 2: Using a multiple baseline across subjects design, adherence to antiretroviral therapy (ART) will improve following initiation of the PM adherence intervention and will be maintained for 6 weeks after tapering of the intervention. * Hypothesis 2a: Similar feasibility, tolerability, and adherence improvement trends will be seen in youth with and without substance problems. Phase 3: To conduct additional proof of concept studies, based on Phase 2 findings, of a text-delivered PM intervention for taking ART in YLH with suboptimal adherence. * Hypothesis 3: Using a multiple baseline across subjects design, adherence to ART will improve following initiation of the PM adherence intervention and will be maintained for 6 weeks after tapering of the intervention. * Hypothesis 3a: Similar feasibility, tolerability, and adherence improvement trends will be seen in youth.
Adherence, Substance Abuse
An estimated 40% of patients in mental health treatment settings engage in hazardous alcohol and/or drug use. One model of intervention that has been shown effective in medical settings to reduce alcohol use and/or promote engagement in addiction treatment is screening, brief intervention, and referral to treatment (SBIRT). Despite the effectiveness of SBIRT for risky alcohol use in medical settings, there has been no research on the effectiveness of SBIRT in mental health treatment settings. Given the proportionately large number of mental health patients who also engage in hazardous substance use, research is needed to find an appropriate and effective substance use intervention for patients in these settings. The proposed study uses a randomized controlled trial to examine the extent to which the World Health Organization's SBIRT model, the ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test) and its associated brief behavioral intervention, leads to reductions in substances prevalent in mental health settings: alcohol, cannabis and stimulants (i.e., cocaine and methamphetamine). The study will also examine the effect of SBIRT on improvement in psychiatric symptoms, improved quality of life and for those whose level of substance misuse indicates a need for treatment, initiation and engagement into SUD treatment services. Eligible participants will be mental health patients who report any past year use of cannabis or stimulants or at least one heavy drinking day in the past year. Mental health patients (N=750) who meet eligibility criteria will be enrolled and randomly assigned to either the SBIRT intervention condition or to a health education attention control condition. Participants will be assessed at baseline on substance use, psychiatric symptoms and quality of life. Each participant will be assessed at 3-, 6- and 12- month follow up points for alcohol and drug use, involvement in SUD treatment services, severity of psychiatric symptoms and quality of life. If successful this study will yield valuable new knowledge about the effectiveness of SBIRT in mental health treatment settings and will promote improved well being of mental health patients. Further, the study will provide evidence on the effectiveness of SBIRT for reducing illicit drug use. Results from this research will be used as the basis for broader dissemination and of SBIRT in mental health settings.
Substance Use Disorders, Mental Illness
The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.
Medication Adherence