28 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the effectiveness of the Big Brothers Big Sisters of America (BBBSA) community-based mentoring (CBM) program for prevention of crime and delinquency/conduct problems, including risk and protective factors for these outcomes. Approximately 2,500 youth ages 10-16 will be randomly assigned to either the CBM program or an untreated control group. Study outcomes will be assessed over a 4-year period via both youth- and parent-report surveys and official records of police/court contact (e.g., arrests).
Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and trauma are particularly at risk for engaging in risky sexual behavior and for contracting HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs for girls who have this combination of behaviors is known to exist at this time. Researchers are developing, assessing, and implementing a family-centered prevention program to decrease girls' participation in the risky behaviors associated with the spread of HIV and STIs. The program also includes a group-based training and support program for parents.
Juvenile crime imposes enormous costs on victims, on society, and on juvenile offenders themselves. However, research assessing the efficacy of interventions for young offenders show, on average, only small effects on recidivism, substance abuse, and other behavioral outcomes. A major problem with existing interventions is that they tend to neglect individual differences in motivation and readiness to make positive changes. In earlier research, we used an empirically validated model of behavior change, the Transtheoretical Model (TTM, the "stage" model), and expert system technology to develop the Rise Above Your Situation program (RAYS), a prototype of a multimedia computerized tailored intervention designed as an adjunct to traditional juvenile justice programs. The intervention delivers assessments and individualized feedback matched to readiness to stay out of trouble with the law and quit alcohol and drugs. At the end each session the program also generates a helpgiver report that summarizes the youth's feedback and presents concrete, easy-to-implement strategies helpgivers can use to reinforce stage-matched concepts. In the current research, the goals are to complete development of the computerized tailored intervention; develop training and other support materials for helpgivers; and assess the efficacy of the intervention package in a randomized clinical trial involving 700 medium- to high-risk court-involved juveniles aged 13-17 recruited by 54 probation officers randomly assigned to treatment or standard care. Primary outcomes will be criminal recidivism and substance abuse abstinence at 6 and 12 months follow-up.
The proposed effectiveness study examines differences in treatment outcomes of an observation-based supervision (BOOST) versus supervision as usual (SAU). The study will be implemented within 16 teams delivering FFT services at 11 sites in the California Institute of Mental Health (CIMH) system. The 16 FFT therapist teams will be randomly assigned either to BOOST or SAU. Each team will have 3 therapists who will treat 6 families for a total of 18 families per team. Thus, each condition will include 24 therapists who will treat 144 families. The project will be implemented in four staggered waves to establish a more even rate of data collection and treatment implementation to enhance the feasibility of the study by keeping staffing and project costs more constant across the 5-year project. Each wave will involve 4 FFT teams, 2 receiving BOOST and 2 receiving SAU. Teams will be randomized to supervision conditions. Outcome assessments of parents and adolescents will be conducted at baseline and at 4 months and 16 months after treatment initiation.
This study is a young adult follow-up of 166 females who originally participated in an RCT during adolescence due to their involvement in the juvenile justice system.
The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the factors that contribute to the behaviors and health of teen girls, such as girl's friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about how to make healthy choices. This study will inform us on ways to help teen girls engage in safe and healthy relationships and adjustment.
This study involves a long-term outcome study of the Catholic Health Initiative St. Joseph's Children (CHI SJC) program using a randomized control study. The purpose of this study is to determine the short-term and long-term impact and effectiveness of the CHI SJC program. The CHI SJC program has not been studied to determine program effectiveness. The investigators intend to follow families and their children until the children in the study graduate from high-school or turn 19 years of age. The study, as a template, uses the eight outcome domains listed and described in the Home Visiting Evidence of Effectiveness website (http://homvee.acf.hhs.gov/outcomes.aspx). These eight domains are: * Child development and school readiness * Family economic self-sufficiency * Maternal health * Reductions in child maltreatment * Child health * Linkages and referrals * Positive parenting practices * Reductions in juvenile delinquency, family violence, and crime The investigators expect to observe significant differences among the two groups with respect to the primary outcome domains listed. The investigators expect study group members randomized to the CHI SJC program will perform better on the eight outcome domains. Other hypotheses include: Other Hypotheses: Hypothesis 1. Randomization to CHI SJC will be associated with higher quality functioning and better child health and well-being. Hypothesis 2. Randomization to CHI SJC will result in more connections to community resources. Hypothesis 3. Randomization to CHI SJC will result in improved indications of maternal health and positive parenting practices. Hypothesis 4. Randomization to CHI SJC will be associated with higher measures of family economic self-sufficiency. Hypothesis 5. Randomization to CHI SJC will be associated with increased school readiness and school progress and attainment. Hypothesis 6. Randomization to CHI SJC will be associated with reductions in juvenile delinquency, family violence, and crime. The study will collect outcome data in the same way and, at the same time, from treatment and control group members. Data collection will primarily be comprised of a set of self-report questionnaires and a review of administrative records that target the outcome domains described earlier. Study group members will be assessed at baseline, 6 months, 12 months, 18 months, 24 months, 3 years, 5 years, 8 years, 12 years, 15 years, and at high-school graduation or 19 years of age.
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.
This randomized controlled study tests an innovative juvenile diversion model that integrates evidence-based family therapy.Immediate and longer term effects of the family intervention will be compared to Services As Usual with 120 adolescents participating in Miami-Dade's Civil Citation Program.
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.
This study will determine the clinical effectiveness, moderators and mechanisms of change, and economic impact of an integrative, family-based intervention that concurrently targets change in HIV/Sexually Transmitted Disease (STD)-associated risk behaviors, drug abuse, delinquency, arrest and mental health outcomes for juvenile offenders committed to a juvenile justice day treatment program.
The fundamental objective of the proposed study is to develop and test an innovative two-stage, cross-systems family-based intervention for substance abusing juvenile offenders. The first stage of the experimental treatment is provided for youths in juvenile detention settings. Stage two of the intervention occurs after the offender is released to the community. Participants are randomized to one of two study conditions: the cross-systems family-based intervention (Multidimensional Family Therapy-Cross Systems (MDFT-CS), or 2) Enhanced Services as Usual (ESAU). Both conditions incorporate HIV prevention in detention and we will also examine the effects of a family-based HIV/STD prevention module beyond the impact of a standard HIV/STD education intervention delivered in detention by including ongoing HIV/STD intervention in MDFT-CS following release from detention. There are five aims of the proposed study. These aims relate to: 1) Intervention development and implementation; 2) Clinical effectiveness; 3) Impact of HIV/AIDS/STD prevention; 4) Comparative benefit-costs; and 5) Systems-level impact
This study evaluates Parenting Wisely (PW), an interactive, computer-based, online parenting program, through a formal randomized trial conducted in collaboration with the juvenile justice system (JJS), the primary market for such a program. Parents of 450 delinquent receiving JJS services as usual (SAU) will be randomly assigned to: PW plus a social networking online discussion forum, PW alone, or SAU. The investigators will also determine the potential marketability of the PW intervention to JJS programs based on the effects of PW on parent report and direct observation measures of parenting behaviors, adolescent behaviors, and family functioning, as well as measures of recidivism and cost savings. User satisfaction, program comprehension, receptivity, and parent self-efficacy will also be assessed. The investigators hypothesize that the two PW interventions (PW only and PW + Social Network) will produce greater reductions in disruptive behavior problems from baseline to 3- and 6-month assessments compared to SAU.
The fundamental objective of this study is to compare the effectiveness of an intensive in-home family-based treatment, Multidimensional Family Therapy, with a multifaceted residential treatment, Adolescent Residential Treatment, over 4 years post-intake and to delineate the mechanisms of change for each treatment. The study targets dually- diagnosed adolescent drug abusers recommended for residential treatment.
The objective of the proposed study is to adapt and implement an efficacious adolescent substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug court service system. Additionally, the investigators will also examine the extent to which MDFT can enhance the effectiveness of existing juvenile drug court services in terms of decreasing drug use, delinquent behavior and arrests and improving school and vocational outcomes. The study design is a fully randomized controlled trial.
The purpose of this study is to evaluate two brief, sustainable interventions for a sample of 280 adolescents charged with an initial drug-related offense: Motivational Enhancement Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents. Families are assessed for adolescent substance use, HIV-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning. It is expected that the combined MET+PW interventions will be more effective than a treatment-as-usual intervention (drug education group) for adolescents with parents not participating in PW.
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.
Arizona has created a pilot program for juvenile probationers called Juveniles under Supervision and Treatment (JUST), which includes swift and certain, but modest responses, to technical violations of the terms of juvenile probation. JUST targets high- and medium-risk juvenile probationers and its stated objective is to reduce violations and overall incarceration of youth in the program. The JUST pilot is being implemented under the authority of the Arizona Governor's Office for Children, Youth and Families (GOCYF) and the Administrative Office of the Courts (AOC).
This project is an evaluation of an intervention to involve youth in creating community change for peace promotion and violence prevention. The intervention, Youth Empowerment Solutions for Peaceful Communities (YES), includes three components: youth empowerment activities, neighborhood organization development, and community development projects that involve youth and organizations working together. Hypothesis 1: Efforts to engage youth in the community change process will enhance their attachment to their community, reduce their problem behaviors, and begin to change norms among their peers about community violence and interpersonal problem solving. Hypothesis 2: Efforts to make community-based organizations more youth-friendly and engaging will assist them to be more effective in reaching their community enhancement goals and will expand youth involvement in their mission. Hypothesis 3: Efforts to create more health-enhancing land use (e.g., beautification, community gardens, parks development) will improve social organization (e.g., social capital, social cohesion, and social support), and reduce the level of violent incidents and crime in the community.
The juvenile justice (JJ) system serves over a million cases every year and represents the primary referral source for treatment of substance use and antisocial behavior in youth. However, engagement of the JJ population in treatment is alarmingly low; further, rural communities have neither access to evidence-based practices (EBPs) nor the finances and treatment infrastructure to support their delivery. However, using an innovation called task-shifting, juvenile probation/parole officers in rural communities might be able to deliver a central change mechanism for EBPs (parent activation), with the ultimate goal of improving JJ youth outcomes.
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.
This study aims to advance the science of mental health services for adolescent externalizing problems (AEPs) by developing therapist training procedures to increase fidelity to evidence-based interventions (EBIs) in usual care. Two widely endorsed approaches are consistently effective for treating AEPs: family therapy and CBT. Importantly, stronger fidelity to core EBIs of these approaches predicts better outcomes in research and community settings. Yet these EBIs are not widely implemented with fidelity. To help close this quality gap in adolescent services, investigators will develop an online intervention to strengthen fidelity to these EBIs in routine care: Measurement Training and Feedback System for implementation (MTFS-I). MTFS-I will target two essential aspects of EBI fidelity: Training components will seek to improve EBI self-monitoring, and a Feedback component will seek to increase EBI utilization. In keeping with NIMH's Experimental Therapeutics paradigm, this study will examine whether an Intervention (MTFS-I) has direct impact on immediate Targets (EBI self-monitoring and utilization). If promising, future R01 studies will examine links among intervention, targets, and ultimate outcomes (AEPs). The MTFS-I package will be an online quality assurance system completed by therapists and supervisors that can be readily sustained in usual care. Two weekly Training components will adapt gold-standard observational fidelity coding procedures to promote improved self-monitoring of the targeted EBIs, and a monthly Feedback component will adapt a measurement feedback system to promote increased utilization of these EBIs in everyday practice. To maximize provider investment, sites will delineate their own fidelity standards for family therapy and CBT and help design feedback report templates. The proposed study will be among the first to (1) test whether training therapists in observational assessment of EBI fidelity increases the accuracy with which they self-monitor use of those EBIs and (2) adapt measurement feedback procedures to track and improve therapist utilization of EBIs. To achieve study aims the investigators will first partner with two community clinics to develop sustainable MTFS-I procedures using a three-phase Pilot process. Investigators will then initiate an experimental Trial during which therapists (n = 32, treating 192 clients) at four different clinics will be randomized to MTFS-I versus no-intervention Control. In both conditions two kinds of data will be collected: therapist-report checklists on use of core family therapy and CBT techniques with adolescent cases and treatment session audio recordings. MTFS-I uptake will be tracked electronically for online components (Aim 1: MTFS feasibility). Session recordings will be coded by observers for three facets of EBI fidelity: adherence (extent of EBI utilization), working alliance, and therapist competence. Observer ratings will measure the strength of EBI self-monitoring (Aim 2: therapist reliability and accuracy) and fidelity (Aim 3 \[EBI utilization\] \& Aim 4 \[alliance, competence\]). If effective, MTFS-I could be adapted to promote EBI fidelity for a variety of clinical populations and approaches.
Youth involved in the juvenile justice system have multiple problems, including an earlier onset of alcohol and drug use and higher rates of alcohol and drug use than their peers in the general population. This 4.5 year study will develop and evaluate a new group intervention for youth who have committed a first time alcohol or drug offense. Teens will be randomized to receive either usual care or the new group intervention. Teens will complete a baseline, post-test (when they complete the intervention, which could vary for each teen but is typically around 6-8 weeks), and a 3-month follow-up survey upon completion of the intervention. The investigators will examine outcomes for a variety of behaviors, including alcohol and drug use and assess whether there are differences between the teens who received usual care and the teens who received the new group intervention.
Juvenile drug courts were developed in response to a perceived need to intervene more effectively with youth with substance abuse problems. Close collaboration between the court and substance abuse treatment provider is a defining component of the drug court model and is critical to helping youth achieve positive outcomes. Despite the proliferation of juvenile drug courts in recent years, however, evaluation of their capacity to reduce offender substance use and criminal activity has lagged. Moreover, the Institute of Medicine (IOM, 1998) and leading experts (McLellan, Carise, \& Kleber, 2003) have presented a bleak picture of the nation's capacity to meet the treatment needs of substance abusing individuals. Although community-based programs provide the backbone of substance abuse treatment in the nation, their capabilities have not kept up with major scientific advances in the development and validation of evidence-based substance abuse interventions. Building on our research findings and experience regarding juvenile drug court outcomes as well as the transport of evidence-based practices to community treatment settings, the purpose of this study is to develop and test a relatively flexible and low cost strategy for enhancing the outcomes of juvenile drug courts by integrating components of evidence-based treatments into existing substance abuse services. Specifically, this project aims to: Aim 1: Adapt existing intervention and training protocols from evidence-based practices (i.e., Contingency Management for adolescent substance abuse; family engagement strategies from evidence-based treatments of juvenile offenders) for integration into juvenile drug court sites. Aim 2: Conduct a study to examine youth (e.g., substance use and criminal behavior) and system level (e.g., intervention adherence, feasibility, retention and completion rates, consumer satisfaction, cost estimates) effects of implementing the intervention protocols in juvenile drug courts. Aim 3: Revise the intervention and training protocols in preparation for a Stage II study if findings are supportive.
This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively.
The goal of this Phase II Small Business Innovation Research (SBIR) is to develop, evaluate, and commercialize a linked parent-youth mobile app system, VillageWhere, to support the key treatment targets of evidence-based treatments for youth with conduct disorders: clear parental expectations, parental monitoring, discipline consistency, and parental support, while simultaneously cultivating intrinsic motivation in youth toward prosocial behaviors. When used in conjunction with an evidence-based treatment for delinquent youth, VillageWhere could help reduce treatment length and cost. When provided in non-evidence-based clinical settings, VillageWhere may increase access to state-of-the-art clinical techniques to those who might not otherwise receive them. Investigators will conduct usability and acceptability tests of new features with target-end-users (youth and their parents) and key stakeholders (i.e., probation officers, clinic administrators). Once usability and acceptability is achieved, investigators will conduct a 16-week randomized controlled trial (RCT) comparing VillageWhere to an attention-control (placebo) mobile app. We expect that across four time points, VillageWhere use will result in greater improvements in parent management practices and youth autonomy support, parent-youth communication and connectedness, youth intrinsic motivation for positive behavior, and youth conduct problems than the placebo. The RCT will occur with 100 parent-youth dyads recruited from various treatment and probation settings, and represent clinically-significant conduct-problems of various clinically-significant severity levels.
Girls in the juvenile justice system are at high risk for dating violence exposure as well as co-occurring problems with delinquency and sexual risk taking. Despite the multitude of negative outcomes associated with dating violence, no evidence-based preventive interventions exist for juvenile justice girls. This study will advance scientific knowledge by testing the efficacy of a promising, skills-based intervention (Date SMART) on reducing dating violence, delinquency and sexual risk outcomes for a broad range of court-involved, non-incarcerated girls.
The goal of the current trial is to assess the feasibility of a newly developed prototype of a cell phone app called VillageWhere. VillageWhere is designed to improve clinical outcomes of youth with externalizing behavioral problems by improving parental monitoring of youth whereabouts and activities while increasing the delivery of rewards to teens for good behavior. This Phase I Small Business Innovation Research (SBIR) proposal seeks to develop and conduct initial feasibility testing of the VillageWhere prototype. The primary features of the prototype include location monitoring via smartphones' global positioning system (GPS) functionality as well as facilitating teen self-appraisal of meeting behavioral expectations. Good behavior is rewarded with points that are tracked by the app and can be used to redeem for real-world rewards. The investigators will conduct an 45-day open trial (N=20 caregiver/teen dyads) to assess use, feasibility and acceptability for teens involved in the juvenile justice system or otherwise struggling with externalizing behavioral problems. Caregivers and teens will be assessed at baseline, before receiving the app, and at the end of the app use period (45 days). The therapist of each caregiver/teen dyad will also be assessed at the end of the app use period. Primary outcomes include: use of app features, monitoring of teen behavior and whereabouts, delivery of real-world rewards, and feasibility and acceptability. Secondary outcomes include: parenting behaviors, externalizing teen behaviors and internalizing teen behaviors.