Active clinical trials for "Child Development Disorders, Pervasive"

The primary purpose of the present study is to evaluate the diagnostic validity of eye tracking measurements acquired during viewing of socially-relevant stimuli in predicting ASD diagnosis. The secondary purpose was to explore the potential prognostic value of eye tracking measures through cross-sectional associations with non-verbal cognitive ability. Deficits in eye gaze are a hallmark sign of autism. A large and growing body of research supports the ability of eye-tracking based measurements to sensitively discriminate individuals with ASD and healthy participants. These investigations have identified that the core deficit in autism as disruption of social attention, reflecting an inability to appropriately engage and track socially- and emotionally-relevant aspects of the visual world. Thus, eye gaze tracking, acquired during viewing of socially-relevant stimuli, may be a useful approach to identifying objective markers of ASD. Eye tracking also carries the advantages of being less intrusive and expensive than MRI and genetic testing and specifically focuses on the core neurobehavioral characteristics of ASD - abnormalities in social attention. After diagnosis of ASD, key clinical tasks in young children involve determining an accurate prognosis and tracking the progress of early interventions. Currently, the only prognostic indicators are clinical observations (subjective and expensive) and non-verbal cognitive ability testing (difficult to acquire, time-consuming, unavailable in many settings). Recently, eye gaze tracking was found to predict functional outcomes. Thus, in addition to being an objective marker for ASD, eye tracking measurements have potential to be useful for predicting cognitive and functional outcomes. Similarly, the only available methods for tracking treatment progress are parental reports (highly subjective), clinical observations (subjective and expensive), and cognitive measurements (expensive and unavailable in many settings. This study will evaluate, using cross-section data, the potential for eye tracking data to serve as a proxy for non-verbal cognitive ability scores in determining prognosis for ASD-affected children. Additionally, this study will evaluate the test re-test reliability of eye tracking parameters that can potentially be used to track treatment progress.

The purpose of this study is to evaluate the utility of and to clinically validate the Autism Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD) compared with other gold standard measures.

The significance of this project is the first longitudinal study to investigate the changes of neurocognitive functions of children and adolescents with ASD and to identify the potential neuroimaging endophenotype (biomarkers) for ASD in Asian with advanced imaging technique (Tract-based automatic analysis, TBAA; multi-echo resting-state fMRI in addition to single-echo resting-state fMRI). The success of this project will fill the gap of our understanding of longitudinal changes of brain function by neuropsychological and imaging approaches of ASD in Han Chinese in Taiwan, and is anticipated to facilitate the progress of translational research in ASD.

This is an outpatient, multicenter, prospective, pivotal, double-blind, within-subject comparison trial of the Marcus Autism Center Investigational Device (MAC-ID) diagnostic procedure relative to the gold-standard (reference standard), current best practice expert clinician diagnosis (ECD) of Autism Spectrum Disorder (ASD) in children 16-30 months of age. Consecutive pediatric patients from the intended population (i.e. children 16-30 months of age) recruited from pediatric referrals and general advertisements will be the subjects of this trial. All subjects will undergo the MAC-ID diagnostic procedure (test). All subjects will also undergo the current best practice clinical diagnostic procedure, using standardized ASD diagnostic instruments and standardized developmental assessments, to produce the ECD of each child's ASD status (reference/gold standard). The study consists of a screening phase and diagnostic evaluation phase to assess the validity (sensitivity and specificity), safety, and effectiveness of the MAC-ID when used to diagnose ASD. Subjects will be enrolled in the trial for a period of 1 day. The trial will be completed in approximately 12 months. The overall study objective is to assess the safety and effectiveness of the MAC-ID to accurately diagnose ASD (primary analysis), as well as to accurately assess severity of ASD (secondary analysis) in very young pediatric subjects. The primary endpoints of this study are the diagnostic result from the MAC-ID and the diagnostic results from the ECD evaluation, both of which are either positive or negative for ASD. Each subject will undergo the Social Developmental Testing Device procedure and an examination by a clinical expert in the field of ASD diagnosis; all study center site personnel (including the expert clinicians responsible for the ECD evaluation) will be blinded to MAC-ID results.

This study investigates the brain response to a single acute dose of Arbaclofen, the R-enantiomer of the GABA-B agonist Baclofen, compared to a single dose of placebo in healthy men with and without autism spectrum disorder.

The primary aims are to identify important gut microbiota signatures for youth with ASD, to identify dysbiosis features for different levels of ASD features and clinical courses, to search the possibility to intervene the disease course if we can tease out the dysbiosis responsible for the flare-up and improvement of the symptoms of the disease. The secondary aims are to identify the clinical and neuropsychological measures that are associated with direct and indirect regulation or interactions from gut-brain axis signaling, and based our preliminary results on reducing the measures for future large-scale microbiome study in ASD.

To date, it is well documented that the gut microbiota (GM) influences numerous physiological processes in the healthy "host". The alteration of the composition and function of the intestinal microbiota, commonly referred to as "dysbiosis", is associated with many pathological conditions. The high co-morbidity between inflammatory bowel diseases and psychiatric symptoms such as anxiety and stress and the frequent presence of gastrointestinal dysfunctions in autistic patients have highlighted a possible implication of GM in psychiatric disorders. The ability of GM to communicate with the central nervous system and the possible influence on behavior led to the discovery of the existence of a microbiota-gut-brain axis. Clinical and experimental data suggest a possible role of modifications in the composition and function of the intestinal microbiota (impaired production of short-chain fatty acids, SCFAs) in major psychiatric disorders such as autism spectrum disorders (ASD). ASD is a severe neurological condition characterized by severe stereotypical behaviors and deficits in linguistic and social interaction. The prevalence of ASD in children is continuously increasing in Western countries. The pathogenesis of ASD is still poorly defined. The clinical manifestations of ASD are the result of complex interactions between genetic, epigenetic, environmental and microbiological factors. The improvement in gastrointestinal symptoms of autistic patients after short-term oral treatment with antibiotics and probiotics clearly indicated a role of the metabolites of MI in ASD. In particular, an alteration in the phyla of Bacteroidetes and Firmicutes in fecal samples from autistic children has been described with conflicting results. Williams and colleagues (2011) evaluated a significant increase in the Firmicutes / Bacteroidetes ratio in intestinal biopsies of autistic children with gastrointestinal disorders. It has also been shown in animal models of ASD that dysbiosis is positively associated with an increase in butyrate levels and inversely associated with the "score" of the severity of ASD symptoms. Alterations in nutritional status, eating habits and adverse reactions to food appear to be more frequent in children with ASD. Several studies support the hypothesis that children with ASD have a greater refusal of food, requiring specific food presentations or eating a reduced variety of foods compared to children without ASD. These conditions are associated with dysbiosis. Preliminary data suggest that particular elimination diets and / or modifications of the intestinal microbiota can determine a positive effect on the symptoms of ASD. A better knowledge of the composition and functions of the intestinal microbiota also in relation to eating habits and the presence of adverse reactions to food in the child with ASD could facilitate new effective strategies for the prevention and treatment of these conditions.

Autism Spectrum Disorder (ASD) is a lifelong, neurodevelopmental disorder effecting one in fifty-nine children. Each individual with ASD is unique. Children with ASD may have trouble making friends, keeping friends, communicating their needs, engaging in leisure activities, learning to read and do math, and many other challenges. The children may engage in repetitive behaviors such as hitting themselves or flapping their hands, and may be over sensitive to particular sounds or lights which can make certain places, such as a store, very uncomfortable. Also, children with ASD may have challenging behaviors such as hitting others and excessive tantrums that can seem uncontrollable. 25 to 40 hours a week of intensive applied behavior analysis is the evidence-based treatment for children with ASD. Many children with ASD in rural areas and certain states are unable to access evidence-based treatment because of insurance barriers and lack of providers. The Competent Learner Model uses strategies from applied behavior analysis to target core skills that increase successful participation in life activities. Its program is applicable across all ages and developmental levels, and it has an online course of study which has been used to train professionals and lay people alike including parents. The purpose of this study was to assess the feasibility of training parents in applied behavior analysis using the Competent Learner Model with children with ASD who do not have access to treatment. The program consisted of a hybrid of group sessions for caregivers, coaching sessions for the caregiver-child dyads, and online units for caregivers. This project assessed participation in and satisfaction with the program as well as changes in parenting stress. Feedback from caregivers will be used to create a more satisfactory method of increasing accessing to families of children with Autism Spectrum Disorder in rural areas.

By comparing them to a healthy control group, this study aims to investigate the relationship between the participation of children with autism spectrum disorder (ASD) in home, school, and community environments and their parents' fatigue, depression, and quality of life, as well as the child's quality of life. There is no study that investigators are aware of that looks into the relationship between the fatigue and quality of life of parents of children with ASD and the quality of life and participation of children with ASD. This study hypothesizes that parents of children with ASD experience more fatigue and have a lower health-related quality of life than parents of healthy children.

Autism Spectrum Disorder (ASD) is the most prevalent of the developmental disorders and their incidence is rising. However, the variability in the behavioral symptoms is large. In part for these reasons, the ASD clinical diagnosis is challenging and often is not made until 3-5 years of age. Thus, there remains an unmet need for a valid and reliable marker which would facilitate ASD diagnosis early in life, enable efficient study of ASD risk factors, and eventually serve as a useful marker to inform the development of effective therapies and assess treatment response in future clinical trials. The specific brain based marker that investigators are currently evaluating is brain plasticity (the changes that occur in your brain through experience). Investigators measure brain plasticity using noninvasive brain stimulation including transcranial magnetic stimulation (TMS) combined with brain imaging, EEG, and behavioral outcome measures. Their work to date demonstrates the potential utility of these techniques in higher-functioning adolescents and adults with ASD, and pilot data support the feasibility and safety of applying the same measures to children and lower functioning individuals. In this study, investigators will evaluate the validity of this marker in low- and high-functioning adults with ASD, in low- and high-functioning children with ASD, and assess the reliability of this marker.