View clinical trials related to Autism Spectrum Disorder.
Filter by:The following protocol was developed with the intention of significantly improving social skills by focusing on increasing relationship skills among children with ASD. Divided into two distinct parts, "Basic Social Relationships" and "Intermediate Social Relationships," the protocol has 4 stages for the former and 5 stages for the latter. Each phase is preparatory to the next, and in addition, a teaching procedure is implemented that adopts three prompt levels (partial, moderate and total), gradually aiming to reduce the assistance provided to encourage independent response. This gradual approach is designed to stimulate greater independence in social interactions. The training lasts between 6 and 12 months, with one or two weekly group meetings lasting forty-five minutes each. Before the start and at the end of the protocol, participants are assessed using the Vineland scale to evaluate their adaptive behaviors. The primary goal is to enable children with autism to develop meaningful social skills, providing them with concrete tools to interact more effectively and independently with their peers, thus improving their quality of life and social involvement. The protocol involves two distinct groups, experimental and control group. The experimental group involves the use of a social robot that acts as a mediator in the interactions among participants. The role of the social robot is to facilitate, reinforce and support the participants' responses during the activities. The therapist coordinates with the social robot, helping to guide, reinforce and support participants' interactions. In the control group, the therapist takes on the role of mediating interactions, helping and facilitating participants' responses. There is no involvement of a social robot; therefore,the therapist self acts directly to guide, reinforce and support the participants' social interactions.
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD.
Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group.
Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility. Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context. Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up. Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone. Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population.
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.
Investigators will recruit up to 10 patients with Anxiety comorbid with Autism Spectrum Disorder (ASD) from the outpatient clinics at MUSC. This pilot trial will be an open-label investigation of the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a nonpharmacological wearable intervention used to manage anxiety and other neuropsychiatric symptoms at home, with patients/caretakers self-administering treatments. Each subject will undergo an initial in-person screening and be consented prior to participating in the study. This will be followed by an in-person training session with the subject (and caretaker if applicable), where they will learn how to self-administer taVNS and ask any pertinent questions. Participants will self-administer taVNS at home twice daily for 4 weeks. These treatments will not interfere with other aspects of their mental health care. Our investigators, over the prior 8 years, have demonstrated that taVNS is safe and feasible in the outpatient setting. Furthermore, investigators have recently demonstrated that taVNS is well tolerated and safely self-administered at home with remote monitoring. The investigators hypothesize that taVNS will be safe and feasible to administer at home in this new population. Results from this study may lead to further exploration of taVNS in this unique population.
Autism spectrum disorder (ASD) is one of the most common developmental disabilities and often people with ASD have sensory processing disorders. These sensory processing disorders are often associated with problem behaviors and, more recently, have been connected to anxiety disorders in people with ASD. While it has been suggested that sensory processing responses in ASD could be malleable, current treatment strategies for sensory processing disorders in ASD have inconsistent results or lack large-sample sized data. This investigation will explore changes in neurophysiological activity in people with ASD and neurotypical peers after they are exposed to an unpleasant visual stimulus through a virtual reality systematic desensitization protocol. 30 people with ASD and 30 neurotypical people between the ages 7 - 35 will be recruited. The study have, 1) a practice magnetic resonance imaging (MRI) visit with questionnaires, 2) a per-exposure MRI with structural and functional MRI collections, 3) a virtual reality systematic desensitization session where we will record the participant's physiological response using an Emotibit device, and 4) a post-exposure MRI session with structural and functional MRI collections. This investigation aims to quantify changes in neurophysiological responses in order to determine the effect of systematic desensitization.
Greater than 80% of children with autism spectrum disorder (ASD) experience sensory differences that make it difficult for them to fully participate in meaningful everyday activities. In this research study, we will use MRI and behavioral methods to assess how sensory interventions might change sensory brain structures, allowing us to better predict which sensory interventions might work best for whom.
To assess sensory processing anomalies in neurotypical children, children with autism spectrum disorder, and attention-deficit hyperactivity disorder, particularly within the vibrotactile and auditory sensory modalities.
This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder.