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NCT01031407
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.
NCT04737707
Dialectical Behavior Therapy (DBT; Linehan, 1993) effectively diminishes emotion dysregulation and self-harm behaviors in a number of disorders. However, to our knowledge, no studies have investigated the efficacy of DBT to treat emotional dysregulation associated with self-harm and suicidal behaviors in adults with ASD without intellectual disability. This randomized controlled study trial aims to assess the efficacy of a 5-month DBT intervention in adults with ASD without intellectual disability who present with self-harm and/or suicidal behaviors.
NCT02747056
The research aims at clarifying the impact of autism on personal identity in adulthood. Two studies will be made in order to compare adults with autistic spectrum disorders without intellectual deficiency and controls. In the first study (Study A), the investigators will ask subjects to tell autobiographical memories and to specify their characteristics by answering focused questions. In the second study (Study B), the investigators will ask subjects to say the self statements which define them. Then, subjects will have to tell and to specify the characteristics of the autobiographical memories linked to these self statements.
NCT07076264
AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist. Overall, this study has 3 major aims. The first aim evaluates the effectiveness of the AquOTic intervention in improving water competency and swim skills, while comparing outcomes between two implementation models: professional student interventionists (occupational and physical therapy students) and trained community-based interventionists. A total of 108 autistic children will be enrolled and randomly assigned to one of three groups: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention. The second aim explores the mediators and moderators of the intervention outcomes to assess fidelity and efficacy. The third aim identifies the cost and resources associated with AquOTic. A cost analysis will be conducted to evaluate the resources required for implementation and to inform the development of a scalable, cost-effective drowning prevention strategy for autistic populations.
NCT02504554
This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders. The combination therapy includes beneficial bacteria.
NCT02747459
The purpose of Sensory Supported Swimming is to provide a sustainable, low cost recreational swim program for children with ASD. A secondary purpose is to train general recreation providers and swim instructors to meet the unique needs of children. Specific aims include both program development and research aims as described below. Specific Aims: 1\. Provide more opportunities for families of children with ASD to access a recreational swim program at low cost. (program development) 2. Increase the capacity of swim instructors and general recreation providers working with children with ASD. (Research) 3. Increase physical activity for children with ASD in a way that is a good match for their individual sensory needs. (Research) 4. Increase safety among children with ASD in and around the water so they and their families can swim safely. (Research) 5. Transition swimmers with ASD from a learn-to-swim program to an inclusive swim team. (Program Development) Hypotheses 1. The Sensory Supported Swim Program will increase physical activity of children with ASD. 2. The Sensory Supported Swim Program will increase safety of children with ASD in and around the water. 3. The Sensory Supported Swim Program will increase the capacity of general recreation providers and swim instructors to serve children with ASD.
NCT06848959
Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy patients.
NCT01361503
The primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20 children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). For comparison, MRS and MRI will also be obtained from 10 healthy control subjects, matched to the 20 subjects with ASD in age, sex, dexterity, and IQ. All eligible subjects will be administered a detailed assessment battery consisting of cognitive assessments (neuropsychological battery including subsets of the DANVA2 and the CANTAB) and measures of psychosocial functioning (SAICA and M-FES). The study includes 1-3 visits for the screening period at Massachusetts General Hospital (approximately 4 hours of assessments) and one scanning visit at McLean Hospital (approximately 1.5 hours). The investigators hypothesize that youth with ASD versus controls will exhibit increased glutamate concentrations, reflecting glutamatergic overactivity, and increased Cho concentrations, suggesting neuronal abnormality. Furthermore, the investigators hypothesize that compared to neurotypical controls, the structural integrity of white mater tracts will be disrupted in ASD.
NCT01250938
The purpose of this study is to test the applicability of a caregiver-implemented autism intervention protocol to a deliberately recruited low-income, underserved population.
NCT02028247
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.
NCT01908686
The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT) to children ages four through six years of age with ASD. Specifically, children will be randomly assigned to receive either (1) 10 hours per week of intervention services, including two hours per week of parent education, and eight hours per week of direct clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.
NCT01691066
The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.
NCT02903030
A randomized pilot trial of a probiotic for quality of life in autism spectrum disorder (ASD), targeting gastrointestinal (GI) symptoms.
NCT01914939
This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders. Participants will be randomly assigned to receive either a social skills-focused CBT intervention or a stress management/relaxation training CBT intervention. Participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The design of the study will enable examination of the efficacy of CBT for young adults with autism spectrum disorders. The design of the study will also allow examination of whether oxytocin enhances the efficacy of CBT. The investigators will perform functional (fMRI) and structural (MRI) imaging with all participants prior to treatment. This will enable examination of the relations between measures of brain function and structure, and improvements in target symptoms over the course of treatment. The aim is to discover whether there are neural characteristics that can identify which participants with autism spectrum disorders are most likely to respond to CBT interventions and/or oxytocin treatment.
NCT01168284
In recent years, there have been a growing number of individuals diagnosed with Autism Spectrum Disorders (ASD). As such, this increase has expanded the number of caregivers of children with ASD. Research has shown that having a child with an ASD is stressful for caregivers and their families. More specifically, prior research suggests that caregivers of children with ASD may find it difficult to maintain feelings of control and to cope with the overall physical and emotional demands of caring for their child. A previous study of caregivers of children with ASD found that caregivers felt a lack of personal control over aspects of their child s condition and also found it difficult to cope with various demands of caregiving. Furthermore, this study found that greater levels of perceived personal control and the use of problem-focused coping strategies were associated with caregivers adaptation to their child s condition. As such, the goal of our research is to conduct a feasibility study using a coping effectiveness training (CET) intervention designed to enhance perceived personal control (PPC) and coping efficacy in caregivers of children with ASD. There has been a growing interest in developing interventions targeted at constructs involved in the adaptation process. However, there have been few studies of interventions targeting predictors of adaptation such as PPC and coping efficacy. Research has shown that the CET intervention can enhance coping efficacy in several other populations. This intervention also incorporates appraisals of one s ability to change a particular situation. The conceptual framework for our study was adapted from Lazarus and Folkman s Transactional Model of Stress and Coping. A cross-sectional randomized treatment-control design is proposed to evaluate the use of a CET intervention intended to enhance PPC and coping efficacy. Caregivers of children with ASD will be recruited from support groups, autism resource centers, and four clinics. Participants randomized to the treatment group will be asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person sessions. Participants randomized to the control group will be asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person client-centered discussion sessions. The main outcome measures will be participation, reasons for withdrawal, participants experiences within the intervention setting and their experiences in applying the intervention, PPC, coping efficacy, and coping effectiveness.
NCT02090829
: The objective of this study is to determine the tolerability and therapeutic potential of oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a computer game intervention that is designed to enhance face perception skills. We designate two measures as our primary outcomes, based on prior published work with these interventions, and we propose a sample based on power analyses from these prior results. A second objective of this study is to learn about the breadth of possible positive effects that this combination therapy might have for children with ASD. To this end, we include a host of other exploratory measures that assess aspects of social motivation and attention, social perception, and social cognition. Thus, a second objective is to conduct a "signal finding" study - to gather outcome data on a range of dependent variables that theoretically should be related to oxytocin's effects on social processes, but for which there are no prior data. The signal finding aspect of this study will provide the preliminary data needed to design a more targeted follow up study.
NCT01962870
Researchers at the Stanford University School of Medicine are seeking participants for a study examining the effectiveness of vasopressin, a neuropeptide, in treating children with autism spectrum disorder. Difficulty with social interactions is characteristic of people with autism, who often have problems interpreting facial expressions or maintaining eye contact while talking with someone. There are currently no effective medicines available to treat social problems in individuals with autism. Neuropeptides, such as vasopressin and oxytocin, are molecules used by neurons in the brain to communicate with one another. Vasopressin is closely related to oxytocin, which is currently being tested as a treatment for autism, and has been shown to enhance social functioning in animals. Animal studies have shown that when the proper functioning of vasopressin is experimentally altered, animals develop a variety of social deficits, including impaired memory for peers and a reduced interest in social interaction. Researchers found that when vasopressin was administered to mice with a genetically induced form of autism, their social functioning improved. Vasopressin is already approved by the Food and Drug Administration for use in humans, and has proved to be a successful treatment for some common pediatric conditions, including bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and memory in people who do not have autism. The researchers will test the effects of vasopressin on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study will last four weeks for each participant. Participants will receive either vasopressin or a placebo nasal spray. At the end of this phase of the study, those who received the placebo will have the option of participating in a four-week trial during which they will be given vasopressin. Stanford is the only site for the study. Participants do not need to live locally but will need to come to the Stanford University Department of Psychiatry and Behavioral Sciences for study visits.
NCT02300597
Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group. The individuals are not randomized due to difficulties to recruit if the individuals do not know group assignment in advance.
NCT02940899
Syracuse University Fit Families is designed to increase the activity level and frequency of the children through modified activities using adapted equipment and, importantly, to increase the families' comfort level in having their children participate in a variety of physical activities, including team and individual sports.
NCT01836965
The objective of this study is to validate a social skills training program manual for adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately 150 adolescents with autism spectrum disorders will participate in this study, in groups consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both group therapy and peer generalization sessions (in the form of a photography class) once a week over the course of twelve weeks. Participants and their parents will complete paper and pencil, online, or phone measures and video-recordings to assess the participant's social skills prior to the intervention, at completion of the intervention and three months later.