Treatment Trials

25 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.

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
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
Description

A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders.

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.

COMPLETED
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
Description

The purpose of this study is to examine whether an exergaming, aerobic physical education (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and classroom functioning among children with behavioral health challenges attending a therapeutic day school. After following an approved consent/assent process, children attending the school were randomized by classroom to take part in either 7 weeks of the experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout period, children then crossed over into the other arm.

COMPLETED
Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention
Description

This trial addresses a serious and all-too-frequent public health problem, namely early-onset disruptive behavior problems in young children. The focus is on testing an online treatment program which empowers parents to help their children to improve their mental health and behavioral functioning. At the conclusion of the study, the investigators will know whether the online-delivered program works as well as an established staff-delivered program, with respect to child disruptive behavior problems, parenting, parent/family stress, consumer satisfaction, and value analysis.

UNKNOWN
Intervening Early With Neglected Children
Description

This study will assess early and middle childhood outcomes of an intervention for neglecting parents that was implemented in the children's infancy. We expect that parents who received the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and will follow children's lead more than parents who received a control intervention, and that children will show better outcomes in attachment, inhibitory control, emotion regulation, and peer relations than children of parents who received the control intervention.

COMPLETED
National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
Description

Trauma-informed treatment will improve emotional regulation and behavior.

COMPLETED
Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits
Description

The purpose of this study is to modify behavior therapy so that it is optimized for children with conduct problems and callous-unemotional traits by emphasizing reward components and de-emphasizing punishment components.

COMPLETED
Resources to Enhance the Adjustment of Children (REACH)
Description

This continuation study evaluates the long-term outcomes of multimodal, modular interventions with early-onset behavior disordered children and innovative methods to promote the maintenance and extension of treatment effects relating to ODD and CD. All participants originally enrolled in the "parent" clinical trial are being followed and those who initially received clinic or community based intervention from a study clinician were randomly assigned to either Booster or No-booster treatment condition. The treatment-as-usual (TAU) and Healthy Control participants were also followed through long-term follow-up assessments paralleling clinically referred participants. The study examines the short and long-term efficacy of booster treatment on clinical outcome, contextual variables, and service satisfaction/use.

UNKNOWN
Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)
Description

This study will determine the advantages and disadvantages of adding one of two different types of drugs to stimulant treatment for reducing aggressive behavior in children with attention deficit with hyperactivity disorder (ADHD).

COMPLETED
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
Description

It is hypothesized that, when given at the lowest effective dose, the favorable side effect profile combined with it's lower propensity for weight gain would make SPN-810 a candidate for treatment of persistent serious conduct problems in pediatric subjects with ADHD.

COMPLETED
School-Based Mental Health Services for Urban Children
Description

This study will evaluate the effectiveness of school- and home-based mental health services and training modules in supporting learning and behavior in financially disadvantaged children who live in urban areas.

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
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.

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
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
Evaluating an Online Parenting Support System Disseminated by Pediatric Practices
Description

This study will experimentally evaluate an internet-based version of the Triple P Positive Parenting Program, the Triple P Online System (TPOS), which presents the Triple P content in an interactive, video-enriched, and personalized format with 3-levels of flexible dosage, and will compare it against usual community services. Thirty pediatric clinics involving 100 practitioners in 9 counties across western Washington will be recruited and randomized to receive (a) access for their patients to the Triple P Online System and training in how to effectively promote TPOS and advise parents on their children's behavior problems or (b) Usual Care Community-Waitlist Control, in which parents will be assisted with an appropriate referral for services in the community.

RECRUITING
Digital Therapeutics for Behavior Problems
Description

In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).

COMPLETED
A Clinic-based Prevention Program for Families of Depressed Mothers
Description

This study will assess the effectiveness of the "Keeping Families Strong" program (KFS) in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

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
A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
Description

The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events (side effects) associated to these drugs.

COMPLETED
Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Description

This study aims to the test the efficacy and cost effectiveness of new service delivery methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent Training (BPT), for early onset disruptive behavior disorders.