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NCT06290258
This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis.
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.
NCT03883139
This research study, Personalized, Responsive Intervention Sequences for Minimally Verbal Children with Autism (PRISM), is designed to maximize language outcomes for limited-language preschoolers, thereby lowering the risk of being classified as "minimally verbal" at age 6, by empirically developing a two-stage, 20-week adaptive intervention approach in a real world community settings. If found efficacious, the adaptive intervention design will capitalize on the heterogeneity and evolving status of children with ASD by providing the best intervention (DTT, JASPER and CET) for children who need it (leading to individualized sequences of intervention), only when it is needed (potentially reducing burden on children).
NCT05750095
Autism spectrum disorders (ASD) are disabling and impairing conditions affecting 1% of children in Norway. ASD is hallmarked by severe social deficit and lack of independence causing reliance on supportive systems throughout life. Parents are usually the primary caretakers and support, often throughout life. Normal parenting skills are however often ineffective due to the social dysfunction of the child with ASD. This causes high stress as the demands exceed the resources and capability of the parent. The high stress is associated to increased risk for mental health problems, divorce, unemployment and reduced quality of life. High parent stress may also reduce the effect of interventions in ASD. However, although the need is great and parental follow-up is an integral part of health care for ASD children, there is a lack of evidence for such interventions. The current project aims to evaluate a specific parent program that is in clinical use - the Incredible Years for children with ASD - compared with a standardised treatment as usual (TAU) composed of clinical parent workshops ("first aid for parents"). The aim is to evaluate parenting interventions and promote evidence-based practice in a clinical setting. The investigators will perform a randomized controlled trial and qualitative interviews to compare the effectiveness of treatment as usual (TAU) versus a manualized parent program (IY-ASLD). The study aims to investigate if the parental program may reduce parent stress and improve parental competence and self-efficacy. Secondary goals are to investigate whether the parent program may improve quality of life for the parent and the child and have an impact on long-term child functioning and service use.
NCT07472829
Recent studies indicate that children with ASD have a significantly higher risk of co-occurring speech sound disorders than typically developing children. Early atypical speech development may be a critical yet overlooked bottleneck hindering their language improvement. Given the unique phonetic features of Mandarin, it is essential to investigate speech development in Mandarin-speaking children with ASD. This study aims to construct developmental trajectories and establish early identification and prognosis prediction models for this population.
NCT05889273
ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.
NCT06894264
BACKGROUND Intellectual disability (ID) is neurodevelopmental disorder with social impairments, in areas such as interpersonal communication skills and emotion regulation. This overlaps with disabilities associated with autism spectrum disorder (ASD). Differences in emotion processing, specifically emotion recognition, reappraisal, and reinforcement learning, has not been compared between patients with ID and ASD. Despite difficulties in emotion regulation among patients with ID, there is a lack of adapted psychotherapy for this patient group. AIMS * To examine differences in emotion processing in individuals with intellectual disability (ID) compared to individuals with autism spectrum disorder (ASD) and typically developed individuals. * To evaluate the feasibility and effectiveness of an adapted psychotherapeutic intervention to improve emotion regulation in individuals with ID. Data and method The first research question is addressed through a cross-sectional study involving 160 participants: 40 individuals with ID, 40 individuals with ASD, and 80 typically developed controls. Participants will undergo psychological experiments where the investigator simultaneously measure eye movement and pupil dilation using an eye-tracker. To investigate different aspects of social cognition, the investigator will use three psychological experiments: emotion recognition, emotion reappraisal, and reinforced learning in a social context. Differences in social cognition are subsequently used in predictive models to predict the group affiliation of study participants. To evaluate the effectiveness and feasibility of an adapted emotion regulation treatment based on Dialectic Behavioral Therapy skills system (DBT-SS), the 40 study participants with ID will undergo a manual-based psychotherapy. The treatment consists of 24 group and individual sessions over 24 weeks. The treatment includes nine skill-systems. Outcome measures are administered at baseline, post-treatment, and at a 6-month follow-up. SOCIETAL RELENVANCE This research addresses a significant knowledge gap in social cognition and mental health in individuals with ID. The results may lead to a better understanding of differences in social cognition compared to individuals with ASD, and effective, targeted interventions for emotion regulation in individuals with ID. In the long run, the treatment could help reduce off-label prescription of antipsychotics to manage behavioral deviations in individuals with ID, as challenging behaviors often stem from difficulties with emotion regulation. PROJECT REALISATION The research group consists of an interdisciplinary composition of experts in neuropsychology, experimental psychology, and implementation of psychotherapeutic research. The project has obtained ethical approval and follows the principles of open science, with pre-registration of study protocols.
NCT05874466
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow device for the detection of autism spectrum disorder in children 16-36 months of age.
NCT06712784
The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and/or caregiver acceptability. The study wil take place at Boston Medical Center (BMC). A Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.
NCT05754073
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.
NCT07439276
In France, more than one in ten school-aged children suffers from a mental health disorder, and half of these disorders appear before the age of 14. Yet, only half of affected children receive appropriate support. At the cognitive level, it is now widely accepted by the scientific community that strong socio-cognitive skills protect against the emergence of certain disorders. Social cognition skills, crucial for development and social integration, are often underestimated in clinical neuropsychology, particularly due to the lack of validated assessment tools for children. The challenges related to the clinical assessment of social cognition in children and adolescents are therefore significant, especially since specific deficits are likely to be associated with numerous developmental pathologies and psychiatric disorders (neurodevelopmental disorders, mood disorders, anxiety disorders, psychotic disorders). However, these disorders are insufficiently assessed. A more precise characterization would allow for the identification of therapeutic targets specific to each neurodevelopmental disorder. Therefore, this research aims to address this lack of tools by using a multidimensional assessment battery of social cognition in children and adolescents aged 8 to 16, evaluating four fundamental domains of social cognition: emotion processing, social perception, theory of mind, and attributional style. This multidimensional assessment battery of social cognition is developed by the Child and Adolescent Psychiatry Department of Necker-Enfants Malades Hospital.
NCT06472115
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.
NCT07248254
It will be conducted as a Quasi Experimental study across pediatric therapy centers, specialized autism clinics, and special schools. Using non-probability convenience sampling, the study will enroll Autistic children aged 6-10 years who exhibit sensory processing difficulties, motor skill delays, and sleep disturbances. Exclusion criteria include other neurological or developmental disorders and children with major physical problems. Motor skills will be assessed with the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and sleep quality will be measured using the Children's Sleep Habits Questionnaire (CSHQ). Participants will be receiving Wilbarger DPPT along with their usual therapy sessions, which may include general occupational therapy, physical therapy, ABA etc. The DPPT intervention will occur three times per week for six weeks, with each session lasting approximately 30-45 minutes, including brushing, joint compressions, and calming activities. Data will be collected at baseline and post-intervention, focusing on motor skill improvement and sleep quality changes. SPSS version 23 will be used for statistical analysis.
NCT07225322
This study investigates the safety and potential efficacy of personalized, image-guided low intensity focused ultrasound (LIFU) targeting the thalamus in individuals with Autism Spectrum Disorder (ASD). The study evaluates behavioral, neuroimaging, and electrophysiological outcomes following LIFU stimulation using a non-invasive device.
NCT05009095
There are limited approaches to specifically address auditory sensory over- and under-responsivity (SOR) in children with Autism Spectrum Disorder (ASD). Exposure therapy (or systematic desensitization) may be a treatment option; researchers are investigating this approach. Many children receive sensory integration therapy, but this approach does not specifically target auditory SOR. Some families are advised to have their children avoid noxious stimuli or use compensatory techniques such as wearing headphones or ear plugs. While preliminary research suggests that use of noise attenuating headphones may reduce sympathetic activation for children with ASD and auditory SOR, this approach does not seek to change or alter the underlying cause of sympathetic activation (Pfeiffer et al., 2019). Sound-based interventions are promising options to treat hyperacusis and subsequent auditory SOR in children with ASD. The objective of this study is to investigate changes in adaptive life skills and behavioral responses in children with ASD using Advanced Brain Technology's The Listening Program ® Spectrum music utilizing Waves ™ (bone conduction) headphones. Our study will investigate the effects of a sound-based intervention developed in 2012 to specifically address the needs of children with ASD and children with hyperacusis and/or auditory SOR - The Listening Program® Spectrum music utilizing Waves™ (bone conduction) headphones by Advanced Brain Technologies. This program emphasizes low frequency music over an extended period of time; the duration recommended by Advanced Brain Technologies is 40 weeks.
NCT07426302
This study aims to evaluate the effectiveness of a virtual reality-based intervention using the Virtual Reality Rehabilitation System (VRRS) to improve executive functions in autistic and ADHD youth aged 8 to 18 years. Executive functions, such as working memory, cognitive flexibility, and inhibitory control, are frequently impaired in individuals with autism and/or ADHD and significantly affect daily functioning. Participants will be randomly assigned to either an experimental group that receives VRRS-assisted cognitive training or a control group that receives treatment as usual. The intervention includes gamified tasks within immersive virtual environments specifically designed to stimulate executive skills. The primary outcome is the change in executive function scores from baseline to post-intervention, assessed using validated neuropsychological instruments. The study adopts a randomized controlled design.
NCT07427940
This is an interventional non pharmacological study in pediatric patientis affected by Autism Spectrum Disorder. It ams to create a collection of iPSCs and hiNSCs derived from deeply characterized ASD patients, to omics-characterize the cells, and to study the behavioral pattern of microglia-like cells in the onset of ASD.
NCT07419919
Physical fitness and psychological indicators are key factors in healthy development. Individuals with autism spectrum disorder (ASD) tend to have lower levels of physical fitness and mental health than their neurotypical peers. This study examined the effects of 10 months of judo training on physical fitness and psychological indicators in children and adolescents with ASD and neurotypical individuals training in integrated groups. Ninety children and adolescents aged 7-14, with and without ASD, participated in the study. Physical fitness was measured using the EUROFIT test, and psychological indicators were measured using the Staic psychological test and the Juczyński questionnaire.
NCT06259201
The goal of this flexible single-subject design vagus nerve stimulation (VNS) study is to examine the behavioral, cognitive, and biorhythmic effects of VNS in children and adults with autism and developmental disabilities. The main aims are: * Pilot the creation of a profile for those who will respond to VNS with the long-term goal of designing clinical trials. * Examine the effects of VNS on a broad range of symptoms. Participants will select between 1, 2, or 3 months of daily VNS treatment and complete study visits each month.
NCT07403396
Children with autism spectrum disorder (ASD) often exhibit postural and balance difficulties, which can impact daily functioning and motor development. Quantitative assessment using Virtual Reality Rehabilitation System (VRRS) provides precise measurements to better understand these deficits and their potential relationship with cognitive functioning. This observational trial aims to evaluate static balance in children with ASD aged 6-10 years. A total of 50 participants were enrolled, with 10 children in each age group. Static balance was assessed using the VRRS and a specific balance task, measuring 13 quantitative parameters including Mean Distance Centre of Pressure (MD\_COP), Root Mean Square of Distance (RMS), Total Excursion (ESC), Velocity (VEL) , and Sway area (SWAY). Cognitive functioning was also recorded using standardized IQ assessments to explore correlations between balance performance and cognitive abilities. All data were stored in a dedicated database for analysis. Participant recruitment: Children diagnosed with ASD will be recruited from the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina as part of an ongoing research program. Withdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the study protocol, and (4) other circumstances that would endanger the health of the subject if he/she would to continue his/her participation in the trial. Virtual Reality Rehabilitation system: The VRRS, a sophisticated technological innovation, aims to generate immersive and interactive settings intended for therapeutic and evaluative objectives. Through the utilization of virtual reality (VR) technology, it constructs diverse scenarios, tasks, and activities in a controlled digital environment, fostering engagement. Primarily crafted for rehabilitation purposes, the VRRS features adaptable programs addressing various therapeutic requirements, encompassing motor skill enhancement, cognitive challenges, and assessments related to balance.