77 Clinical Trials for Various Conditions
This multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1.
Healthy Volunteer, Autistic Disorder, Asperger's Syndrome
The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.
Autism Spectrum Disorder (ASD), Autism, Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
Autism Spectrum Disorder (ASD), Autism, Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome, Autism Spectrum Disorders, Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating anxiety symptoms, social problems, and adaptive behavior deficits in children with autism spectrum disorders.
Autistic Disorder, Asperger Syndrome, Anxiety Disorders
Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder and when adapted, shows promise in children with ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid anxiety. Given this, the present study seeks to develop and test a new CBT therapy in adolescents with autism and comorbid anxiety.
Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified
This study is a pre-test, post-test single group design with follow-up at month three. Twenty-four individuals total will participate in this study with 6 participants in each of 4 cohorts. Participants and their parents will complete pre-test measures including both paper and pencil measures and a video-recording to assess the participant's social interaction skills and fluency. These adolescents will participate in both group therapy and peer generalization sessions once a week over the course of twelve weeks. Upon completion of the intervention, participants and parents will complete paper and pencil and video post-test measures. Participants will be encouraged to participate in one follow-up session where the paper and pencil and video measures will be completed again.
Asperger's Disorder, High-functioning Autism
Background: * Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Researchers are interested in using interviews and rating scales to better understand these issues, as well as collecting brain scan data and genetic samples for testing and comparison. * By comparing test results and genetic samples from healthy volunteers, people with ASD, and parents (or caregivers or legal guardians) of the first two groups, researchers hope to better understand the neuroscience of ASD. Objectives: * To learn more about the brain in healthy people and in people with autism spectrum disorders. * To study genes that might be involved in autism spectrum disorders by collecting DNA samples from participants. Eligibility: The following groups of participants will be eligible for the study: * Individuals between 5 and 89 years of age who have autism spectrum disorders. * Healthy volunteers between 5 and 89 years of age. * Cognitively impaired children between 5 and 17 years of age. * Parents/caregivers/legal guardians of individuals in the above three groups. Design: * Participants will visit the National Institutes of Health Clinical Center for research tests, which will be administered over multiple visits. Researchers will determine the specific tests to be administered based on the medical history of the study participant. * Researchers will study the brain through interviews, tests of thinking and memory (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and magnetoencephalography (MEG). * The study will also collect blood or saliva to obtain a DNA sample.
Asperger's Disorder, Mental Retardation, Children, Adult, Autism Spectrum Disorders
This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.
Asperger's Syndrome, Dyslexia, Cerebral Palsy, Attention Deficit Disorder, ADHD, Traumatic Brain Injury, Stroke
This study will be an open-label, 12-week trial of risperidone in subjects with Asperger's Disorder, according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) Criteria. The study has two arms, one involving pre- and post-treatment MRS studies, and one without MRS. The MRS arm will study 18-20 subjects ages 6 and above, with a target of 14 completing patients. For both arms, we plan to a enroll at total of 30 patients to achieve completion for 24 patients. The non-MRS arm of the study will include subjects 6-18 years of age, the bulk of which have completed the study as of the writing of this updated revision. Our hypotheses are that treatment of Asperger's patients with a low dose of risperidone will: 1. decrease ratios of N-acetylaspartate (NAA), creatine, phosphocreatine (Cr + PCr), and choline in the prefrontal lobe, and 2. decrease the severity of negative symptoms and overall improve social behavior, and 3. that the two will be correlated. Specific Aims The primary objectives of this trial are to: * Further assess and investigate the utility of risperidone in the treatment Asperger's disorder. * Assess the efficacy of risperidone in normalizing increased frontal lobe metabolites. * Assess the efficacy of risperidone in normalizing symptoms in Asperger's disorder patients using standardized rating scales to assess the impact on negative symptoms and on social interaction. * Determine whether risperidone's effect on clinical improvement of Asperger's disorder, i.e., negative symptoms, is correlated with normalization of frontal lobe metabolites * Accrue safety and tolerability data on risperidone for this population of patients. This information could potentially be used to provide pilot data for a double blind trial
Asperger's Disorder
The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This is an open-label investigation of aripiprazole in the management of the maladaptive behaviors of autistic disorder. We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior.
Asperger's Disorder, Pervasive Developmental Disorder
Abstract: In Phase I, we designed and tested a Portable Visual Guidance System (PVGS), which combines a PDA - for user guidance - and an Internet website - for linking the user to an educational support team. Use of the PVGS 1) significantly improved the in vivo social pragmatics of students diagnosed with Aspergers Syndrome/Higher Functioning Autism (AS/HFA); 2) revealed additional ways of improving social pragmatics; and 3) improved activity management in scheduling and vocational tasks. In Phase II, we will focus on social pragmatics and two closely related skills: feelings management and assignment management. We aim to: 1. Replicate Phase I success in the most educational setting for AS/HFA high school aged students: mainstream school inclusion classes. 2. Replicate Phase I findings more efficiently, with a less highly trained, on-site coaching staff and with more distant (non-site) expert supervision of that staff. 3. Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control group. 4. Develop and implement software that will enable on-site staff to create and modify individualized guidance and monitoring screens as needs arise. 5. Design a commercially attractive package of software, video training, video-conferenced support, and manuals. 6. Complete the translation of the SymTrend website and all the above tools into Spanish. Significance: Successful completion of Phase II will: 1. Provide a very effective and comprehensive system for teaching social pragmatics and related management skills to AS/HFA persons in an inclusion context. 2. Provide a means of evaluating IEP effectiveness, thereby enabling a better use of special education funds and a reduction of litigation over IEP plan appropriateness and utility. 3. Provide substantial support for our theoretical rationale for curriculum building in Special Education - a rationale that can guide the formulation of IEPs. 4. Provide a theoretical rationale, an intervention framework, and intervention support technology that can be extended to cognitive behavioral treatment of other neuropsychiatric disorders and can be adapted for other forms of healthcare guidance. 5. Provide an investigative system, as well as an intervention system, for tracking behavioral change in studies of frontal lobe and limbic neuroplasticity in neuropsychiatric disorders.
Asperger Syndrome, High Functioning Autism
The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.
Autism Spectrum Disorder, Autism, Autistic Disorder, Asperger Syndrome
Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have been made. Research has shown that individuals with FXS process sounds differently than those in the typical population, and they also show baseline differences in brain activity, including high gamma activity, increased theta activity, and decreased alpha activity. The investigators' central hypothesis is that these alterations in brain activity (specifically alpha and gamma activity) impair the brain's ability to process new information, thereby impeding cognitive functioning and increasing sensory sensitivity. The investigators propose that auditory entrainment, a technique that involves playing special sounds through headphones, will normalize brain activity in individuals with FXS and lead to increased cognitive function and decreased sensory hypersensitivity.
Fragile X Syndrome, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
The purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.
Autism, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Pervasive Developmental Disorder
This is a clinical trial of a novel intervention, Behavioral Therapy for Irritability and Aggression (BTIA), for adolescents on the autism spectrum. The main goals of BTIA are to help adolescents develop emotion regulation skills to handle frustration and to strengthen skills for navigating the challenging and diverse experiences associated with the transition to adulthood. The study will test whether BTIA can be helpful to adolescents on the autism spectrum and to their families.
Autism Spectrum Disorder, Irritability, Disruptive Behavior, Anger, Aggression, Asperger Syndrome, Pervasive Developmental Disorder
Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.
Autism Spectrum Disorder, Autism, Asperger Syndrome
The goal of this study is to characterize biophysiolgoical signals as a comprehensive profile of the nervous systems in order to understand interactions between the brain and body, while an individual performs naturalistic behaviors (ex. walking, pointing) and while breathing at a slow controlled pace. The investigators aim to study these interactions among a variety of populations, from healthy individuals to those with disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD (Attention-deficit/hyperactivity disorder) diagnosis, Asperger's Syndrome, Alzheimer's Disease, and/or Fragile X syndrome
Autistic Disorders Spectrum, Adhd, Asperger Syndrome, Alzheimer Disease, Parkinson, Tremor Essential, Dementia, Alzheimer Type, Lewy Body Dementia With Behavioral Disturbance (Disorder), Dementia With Lewy Bodies, Dementia Frontal
Locomotor, transport and information functions in human body systems are carried out by active media in autowave regimes! Any living organism is a (micro-macro-mega) hierarchy of autowave subsystems-an ensemble of loosely coupled subsystems of a simpler structure. From the highest levels of the hierarchy, Autowave Codes-Signals arrive, which determine the transitions of subsystems from one autowave regime to another Autowave interaction (of Complex Coherent Action). Autowave interaction is a process associated with the evolution and interaction of spatial and wave structures in the active media of the organism. Chaos in organism functioning tells about health. Periodicity - Autowave reverberator may presage a disease - Autism Spectrum Disorder; Chaotic nature of oscillations in active media of physiological systems is more optimal for their vital functions than periodic one. Firstly, systems that function in chaotic regimes, can re-arrange themselves faster and easier in case of change of environmental conditions, i.e. the so called adaptive control is more easily implemented in them. Secondly, "spreading" of oscillations strength along comparatively wide frequency band takes place in chaotic regime. When an organism is young and healthy, physiological systems show the elements of chaotic behavior, i.e. irregularity and chaotic dynamics are the extremely important characteristics of health. Decrease in changeability and appearance of stable periodicity of Autowave reverberator are often connected with Autism. The main purpose is to study brain plasticity (the changes that occur in the brain through Autowave reverberator) in children with autism. Research suggests that during development, the brains of children may change in response to their Autowave reverberator differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of autism spectrum disorder (ASD). In this study, the investigators will be examining the effects of non-invasive neuromodulation SQUED™ series 28.1 home-use for Treatment of Autowave reverberator of Autism. Integrative Team World Organization of Medical Synergetics (WOMS) - collaborations between physicians and researchers with expertise in biostatistics, physics, mathematics, engineering, and computer science.
Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Neurodevelopmental Disorders, Mental Disorders, Asperger's Syndrome, Neurobehavioral Manifestations, Nervous System Diseases
This study will investigate and confirm the efficacy of two psychological treatments for adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive remediation intervention that aims to help adults with problems in thinking, planning, and socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that aims to help adults learn about their condition, manage their emotions and stress, improve their social skills, and cope with everyday problems.
Autistic Disorder, Autism Spectrum Disorder, Asperger Syndrome, Pervasive Developmental Disorder
Background: Some patients with unusual genetic conditions are referred to the National Institutes of Health (NIH). They may not be eligible to join current research studies. Testing such patients is a good way to improve the skills of research staff. The findings could lead to new processes and research. Objectives: To recruit a diverse group of pediatric subjects with genetic disorders. To give clinic staff hands-on experience working with these patients. Eligibility: Children any age with a known or suspected genetic disorder. Design: Participants will be screened with medical history and physical exam. They may have lab and other tests. Family members may give DNA samples. Participants will have: Medical history Physical exam Height, weight, and other measurements taken. A clinical evaluation of their disorder. They may have: Blood, urine, and saliva samples taken Imaging tests. These may include x-rays, scans, ultrasound, or skeletal survey. A sleep study A visit with other specialists at NIH A genetic test from a commercial lab Medical photographs taken Other tests Participants may have follow-up visits. They may get medical or surgical treatment.
Genetic Disorder, Asperger Disorder, Autism Spectrum Disorder, Fragile X Syndrome, Developmental Delay
This study examines how the PEERS (Laugeson \& Frankel, 2010; Laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults.
Autism Spectrum Disorder, Asperger Disorder, PDD-NOS, Autism
If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. IGIV treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.
Autism, Autistic Disorder, Asperger's Disorder, PDD, Pervasive Developmental Disorder
Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.
Autism Spectrum Disorders, Autism, Asperger's Syndrome, Pervasive Developmental Disability - Not Otherwise Specified, Obsessive-compulsive Disorder, Social Phobia, Generalized Anxiety Disorder, Specific Phobia, Separation Anxiety Disorder
This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS) for subjects with autism spectrum disorders, specially targeting repetitive behaviors.
Autism, Asperger Disorder, Other Developmental Pervasive Disorder
Children with Autism Spectrum Disorder (ASD) commonly experience behavioral challenges that may be improved with pharmacotherapy, including difficulties with sleep, attention, hyperactivity, impulsivity, anxiety, obsessive-compulsive behavior, mood swings, self-injury, and aggression. While 34-58% of children with ASD take medication for such behaviors, there is wide practice variation nationally and a lack of evidence to support the use of most commonly prescribed agents. Complex clinical situations such as this where there is no clear "best choice" regarding which behaviors to target and which medications to use lend themselves well to the use of a Shared Decision Making (SDM) tool to ensure that well-informed parent preferences shape every treatment plan. The primary goal of this study is to modify a previously published decision aid about use of medication to manage challenging behaviors in children with autism to make it easy to implement in practice and then evaluate this version in terms of proximal decisional outcomes and parent/child outcomes 3 months later. Providers in a Developmental-Behavioral Pediatric clinic will be enrolled and randomly allocated to intervention or control (treatment as usual) groups. Initially, providers randomized to the intervention group will test and refine the modified intervention. Once the intervention is finalized, eligible patients of participating providers will be enrolled in the randomized controlled trial to test the efficacy of the intervention. Following the trial, control group providers will be crossed over and receive the intervention. Both proximal decisional outcomes (e.g. parent decisional conflict, provider amount of SDM, parent knowledge of treatment options) and outcomes 3 months later (e.g. parenting stress, decisional conflict, and change in child behavioral symptoms) will be assessed. Approximately 10 providers and 240 of their patients with autism will be included in the study. Chart reviews, parental surveys, and recordings of provider-parent-patient interactions during the index visit will be collected at baseline (prior to physician allocation), during the intervention trial, and after the control group has crossed over. Between- and within-group analyses will examine factors associated with parental decisional conflict and whether the intervention produces significant improvements in outcomes over and above typical autism care. Analyses will include multiple linear regression modeling and general linear models / repeated measure models, accounting for data clustered by provider.
Autistic Disorder, Pervasive Developmental Disorder, Child Development Disorders, Pervasive, Asperger Syndrome, Autism Spectrum Disorder, Autism
Autism spectrum disorders affect as many as 1 out of 88 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.
Autism, Asperger's Syndrome, Pervasive Developmental Disorder Not Otherwise Specified, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety Disorder, Obsessive-compulsive Disorder, Specific Phobia
The purpose of this study is to examine the use of, and reaction to, one particular software application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com). The hypothesis is that the use of these devices will increase engagement, motivation, interest, and have perceived benefits to users with unique attention-limiting cognitive disabilities. How does the observation of and user feedback from gameplay reveal areas of improvement for the game, strengths, and perceptions of value among the players and adults?
Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Pervasive Developmental Disorder, Asperger's Disorder
The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform decisions about including a lurasidone arm in a future large scale trial of different approaches to minimize antipsychotic associated weight gain in the pediatric population. In adults, lurasidone appears to cause minimal weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum, or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic exposure.
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychosis NOS, Autistic Disorder, Asperger Syndrome, Child Development Disorders, Pervasive, Bipolar I Disorder, Bipolar II Disorder, Mood Disorder NOS, Severe Major Depression With Psychotic Features, Single Episode Major Depression Without Psychotic Symptoms, Severe Mood Disorder With Psychotic Features
In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches children to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance. This form of CBT has been well-studied in typically developing children with disruptive behavior and we are investigating if this treatment can be feasible and helpful, with appropriate modifications, for irritability and disruptive behavior in ASD.
Autism, Autism Spectrum Disorder (ASD, Asperger's Disorder, Pervasive Developmental Disorder (PDD-NOS)