Treatment Trials

24 Clinical Trials for Various Conditions

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COMPLETED
Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD
Description

Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD.

COMPLETED
Prevention of Substance Use in At-Risk Students: A Family-Centered Web Program
Description

The purpose of this study is to develop and evaluate the effectiveness of a web-based version of the Family Check-up (FCU). The FCU is a school-based family-centered intervention that has been developed over the past 20 years and tested across the United States with diverse populations. It focuses on enhancing parenting skills and family management in early adolescence. The FCU has been shown to be highly effective at reducing adolescent problem behavior, achievement problems, depression, and substance use over an extended period of time. In the original FCU, parents complete an assessment that evaluates family strengths and challenges. They then receive feedback from a family consultant about how their data compare to other families with children of the same age. As part of this feedback session, the consultant helps motivate parents to make changes at home that will positively impact their child and family overall. Parents and consultants decide together which child behaviors they most want to see change. The consultant then works with parents to enhance relevant parenting and family management skills. Despite the demonstrated effectiveness of this intervention, few schools have the resources and staffing to implement it without substantial support. It seems, then, that schools would benefit from an online package that requires fewer school resources to implement. The FCU-Online is designed to incorporate the successful components of the original FCU while reducing the burden on schools. And, because it is accessed online, parents can utilize this resource at a time and location convenient to them. In this study, 300 families will be randomly assigned to one of three conditions: a web/ mobile-only version of the FCU, a web/mobile + coach version, or middle school as usual. Research on mental health interventions delivered over the internet suggests that a coach or "in-person" contact enhances outcomes. However, programs that require no coaching or in-person contact are cheaper and easier for schools to deliver. Therefore, a web/ mobile-only version may allow more schools to deliver the intervention to a greater number of families and children. Thus, investigators will test the relative effectiveness of a coach version versus an online-only version at improving key parenting skills. It is predicted that changes in parenting will lead to reductions in risk behavior, such as problem behavior at school and substance use.

COMPLETED
VillageWhere: Innovative Mobile Technology for Youth With Conduct Disorder and Their Parents
Description

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.

TERMINATED
Effects of Atypical Antipsychotics on Brain Function in Children and Teens With Conduct Disorders
Description

Background: - Some children and teenagers have conditions known as conduct disorders. They often have long-term chronic behavior problems, such as defiant behavior or violence. Conduct disorders are often treated with antipsychotic medication. Researchers want to study two types of newer antipsychotics (aripiprizole and risperidone) for children and adolescents with conduct disorders. They will look at how these drugs affect brain activity. To do so, they will give brain activity tests using magnetic resonance imaging (MRI). The tests will compare the results from healthy volunteer children and teens to those of others with behavior problems. Objectives: - To see how atypical antipsychotics affect brain activity of children and teenagers with conduct disorders. Eligibility: * Children and teenagers between 10 and 18 years of age who have a conduct disorder and are taking aripiprizole. * Children and teenagers between 10 and 18 years of age who have a conduct disorder and are taking risperidone. * Children and teenagers between 10 and 18 years of age who have a conduct disorder and are not taking an atypical antipsychotic. * Healthy volunteers between 10 and 18 years of age. Design: * Participants will be screened with a physical exam and medical history. Parents/guardians will be asked questions about their child s feelings, experiences, and behavior. Participants will also answer questions about their feelings and moods. * This study will involve two visits. Each visit will involve MRI scanning. * At the first visit, participants will have memory and thinking tests. The tests will involve making decisions or playing games. Some of these tests will use MRI scanning to look at brain activity. * The second visit will be 3 to 5 months after the first visit. The tests from the first visit will be repeated.

COMPLETED
Integrated Smart Speaker Promoting Positive Parenting Among Caregivers of Youth With Challenging Behaviors
Description

This project will develop and evaluate the feasibility of an integrated smart speaker and mobile/web-based application, "FamilyNet" (FN) to assist parents in implementing empirically supported behavioral parenting strategies to promote positive behavior change in their children. The FamilyNet system will help parents to create a positively framed, individualized behavioral plan for their child(ren), and then provide prompts, reminders, and tracking tools to help them effectively implement that plan. Once developed, FamilyNet will be field tested for usability and usefulness with a group of parents who have children ages 10-17 years exhibiting challenging behaviors. Establishing feasibility of this innovative parenting tool will have important implications for harnessing smart speaker and mobile/web technologies to provide parents in-situ support with parenting challenges; parents' effective implementation of empirically supported parenting strategies is likely to increase children's prosocial behaviors and reduce problematic behaviors, thus reducing their risk for long-term behavioral problems.

RECRUITING
Digital Single Session Intervention for Youth Mental Health
Description

The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.

COMPLETED
Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
Description

Childhood ADHD and comorbid oppositional defiant disorder (ODD) and conduct disorder (CD) are considered risk factors for subsequent substance abuse, and youth with both ADHD and ODD/CD are at greatest risk. However, the effects of treatment of ADHD with stimulant medications such as methylphenidate (MPH) and mixed amphetamine salts (MAS) on risk for substance abuse are poorly understood. The study team propose to use fMRI to study the effects of extended release mixed amphetamine salts (MAS-XR) in drug-naïve youth 7-12 years at low risk (i.e., ADHD only) and high risk (i.e., ADHD + ODD/CD) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.

ENROLLING_BY_INVITATION
Intervening Early: Key Adolescent Outcomes
Description

This study follows children into adolescence who were first randomized to intervention condition in infancy.

COMPLETED
Study of Cognition and Control in Youths
Description

The purpose of this study is to learn more about the functioning of particular types of regions of the brain, specifically, those related to externalizing disorders such as Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiance Disorder (ODD), and Conduct Disorder (CD). Brain function of children and adolescents with externalizing disorders such as ADHD, ODD, and CD will be compared to the brain function of those without. Functional Magnetic Resonance Imaging (fMRI) will be used to monitor brain activity at work and at resting states.

COMPLETED
Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth
Description

The project involves testing the efficacy of an animal-assisted intervention (AAI). The AAI consists of a 10-week program in which adjudicated adolescents train shelter dogs and will be compared to a dog walking control group matched for educational content and dog contact time. The investigators expect that the AAI will result in improved empathy skills and that dog attachment will explain these findings. The investigators also explore the extent to which the AAI will improve internalizing and externalizing symptoms in these adolescents.

COMPLETED
A Family Intervention for Adolescent Problem Behavior (AKA Project Alliance 2)
Description

The goal of this project is to empirically refine and improve a comprehensive family-centered prevention strategy for reducing and preventing adolescent substance use and other problem behaviors. This project builds on 15 years of programmatic research underlying the development of the Family Check-up model (FCU), originally referred to as the Adolescent Transitions Program (ATP; Dishion \& Kavanagh, 2003), but later expanded as a general approach to mental health treatment for children from ages 2 through 17 (Dishion \& Stormshak, 2007). The FCU model is a multilevel, family-centered strategy delivered within the context of a public school setting that comprehensively links universal, selected, and indicated family interventions. Previous research and the investigators' practical experience working in school settings indicate that the intervention strategy needs improvement in 3 critical areas to build on previous significant effects and to enhance the potential for future dissemination and large-scale implementation:(a) improve the feasibility of both the universal level and the indicated level of the intervention by broadening the intervention components and systematically embedding these components into the current behavioral support systems in the schools; (b) address the transition from middle school to high school, with special attention to academic engagement and reduction of deviant peer clustering; and (c) explicitly incorporate principals of successful interventions with families and young adolescents of diverse ethnic groups into both the universal and indicated models. An additional general goal of this study is to develop, test, and refine a set of research-based instruments that facilitate evaluation, training, implementation, and monitoring of intervention fidelity to maximize the potential success of implementation and large-scale dissemination. Participants include 593 youth and their families recruited from the 6th grade in three public middle schools in Portland, OR. Families were randomly assigned to receive either the FCU intervention model or treatment as usual. Assessments were collected for 5 years through the 10th grade. High school transition planning and intensive intervention efforts occurred in Grades 7-9. The investigators tested the hypothesis that the FCU intervention will reduce the growth of problem behavior and substance use through the enhancement of family management and parent involvement in school.

COMPLETED
Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Description

The primary aims of this study are to assess: 1. The inter-rater and test-retest reliability of the MINI-KID 2. The validity of the standard MINI-KID interview in relation to the parent rated pencil/paper version (MINI-KID-P) and th longer clinician rated "Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) and "expert opinion" (when available). Secondary aims will include evaluating the concordance between: The Children's Global Assessment Scale (a required part of the K-SADS) with the clinician-rated Sheehan Disability Scale (to be administered with the MINI-KID) as a measure of illness severity.

COMPLETED
Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth
Description

This study will examine the effectiveness of a multiple family group mental health service delivery strategy in improving mental health service use and outcome for urban, low income children of color, ages 7-11 years old with disruptive behaviors and their families.

COMPLETED
Home Based Treatment for Drug Use in Early Adolescents
Description

This study will compare two programs to see if they are helpful in preventing the use of substances in adolescents with attention deficit-hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), or conduct disorder (CD). One of the programs involves working with adolescents and their parent(s) in their home. The other program involves working with adolescents and their parent(s) in an office setting.

COMPLETED
Trial of Aripiprazole in the Treatment of CD in Adolescents
Description

The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder. The initial dose depending on the weight of the patient will be as follows: \< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \> 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). For the first two weeks of the study, the dose will be flexible based on response and tolerance and thereafter will remain fixed.

COMPLETED
Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
Description

This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with attention deficit hyperactivity disorder (ADHD).

COMPLETED
Brain Changes in Children and Adolescents With Behavioral Problems
Description

Purpose: This study will examine brain activity in children age 10-18 with disruptive behavior problems, including conduct disorder (CD), oppositional defiant disorder (ODD), and attention deficit hyperactivity disorder (ADHD), compared with children without behavioral problems. Our goal is to examine differences in how emotions, social situations, and problem-solving situations are processed in the brain across these groups of children.

COMPLETED
Prevention of School Dropout for Mexican American Adolescents
Description

The purpose of this study is to test the efficacy of a family-based psychosocial intervention to prevent school disengagement and reduce the incidence of depression, conduct disorders, and school dropout for Mexican American adolescents.

COMPLETED
Long-Term Lithium Treatment for Aggressive Conduct Disorder
Description

This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).

COMPLETED
Virtual Reality to Improve Social Perspective Taking
Description

This project will examine how virtual reality treatment that provides users with the alternate perspective of a virtual interpersonal interaction impacts psychological and neurobiological markers of social perspective taking in children with a disruptive behavior disorder. The investigators anticipate that experiencing a virtual encounter from a counterpart's point-of-view improves a child's perspective taking and alters brain function related to imagining another person's pain.

COMPLETED
Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder
Description

This study will evaluate the effectiveness of two different psychosocial therapies, parent management training and collaborative problem solving, in treating children with oppositional-defiant disorder.

RECRUITING
Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
Description

This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD) display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Researchers will describe the moods and behaviors of children with these symptoms and use specialized testing and brain imaging to learn about the brain changes associated with this disorder.

Conditions
COMPLETED
Study of Children at Risk for Disruptive Behavior Disorders
Description

A conduct disorder is characterized by repetitive and persistent patterns of behavior where the basic rights of others and rules are violated. This study investigates characteristics of children and their surroundings (environments) that place them at risk for the development of disruptive behavior disorders and associated disorders of anxiety and mood. Children ages 4 - 5 with moderate (subclinical) and severe (clinical) rates of misconduct during the preschool period are compared to low risk children. Children and their families were recruited from 1989-1991 and are being studied at five specific times: 1. Preschool (4 - 5 years) 2. Early childhood (6 - 7 years) 3. Middle childhood (9 - 10 years) 4. Early adolescence (13 - 14 years) 5. Mid-adolescence (15 - 16 years) Researchers will look closely at biological, intellectual, emotional, and behavioral factors that are thought to protect against and/or increase the risk of developing a conduct problem. These factors have been studied in older children and are shown to be associated with disruptive behavior disorders. The goals of this research study are; 1. Create a database showing the characteristics of the development of disruptive behavior problems. 2. Identify the key risk and protective factors that contribute to the stability or change in behavior problems over time. 3. Identify the ways that children interact socially and relate them to the possibility of developing a problem of behavior. 4. Identify how experiences and the emotions associated with experiences may play a role in the development of related psychiatric conditions, like depression and anxiety. 5. Establish measures of the different components of negative emotions associated with disruptive/antisocial, anxiety, and mood disorders.

COMPLETED
The Role of Emotion in the Development of Psychopathology
Description

The dysregulated experience and expression of emotion is implicated in psychiatric disorders associated both with externalizing problems (aggressive, antisocial behaviors) and internalizing problems (anxiety, depression). Adolescence is a critical juncture in the development of these disorders because of the increased incidence and differentiation of clinical problems during this time period. This is a biobehavioral, longitudinal investigation of the role of emotion in the development of psychopathology in adolescence. The focus is on socialization experiences and biological processes that contribute to emotion dysregulation and disorder in male and female youths between 11 and 16 years of age. Groups studied include (1) comorbid externalizers and internalizers, (2) externalizers only, (3) internalizers only, and (4) asymptomatic youth. The adolescents are assessed again two years later, with instruments and paradigms similar to those used at Time 1. One theme pertains to the integration and disconnection of emotions across systems (e.g., physiological and self-report of experience), and how different patterns of emotion relate to psychopathology. A second theme pertains to development changes in how disorders are manifested (e.g., increased differentiation along gender specific pathways). The anticipated number of patient days per year is 240 for adolescents and mothers, and 120 days for fathers.

Conditions