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Autism Spectrum Disorder clinical trials

View clinical trials related to Autism Spectrum Disorder.

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NCT ID: NCT06214065 Recruiting - Clinical trials for Autism Spectrum Disorder

Modulating Temporoparietal Junction Mentalizing-Related Activity in Autism Spectrum Disorder (ASD) Using Transcranial Magnetic Stimulation (TMS)

Start date: April 3, 2024
Phase: N/A
Study type: Interventional

The goal of this observational study is to test the modulation effect of different transcranial magnetic stimulation (TMS) on the neural network supporting our ability to create mental representations of others (also known as mentalizing) in young adults with autism. The main question it aims to answers is can stimulation of the right temporoparietal junction can change brain activity related to mentalizing during social interaction in the stimulation area and other brain areas connected to it. Researchers will compare results to a group of individuals without autism to see if the patterns of neural activity change are similar between the groups. Participants will undergo assessment of their clinical traits and social skills and baseline MRI scan. They will attend three additional visits that include TMS session and functional MRI scans before and right after TMS.

NCT ID: NCT06213090 Recruiting - Epilepsy Clinical Trials

Patterns of Neurodevelopmental Disorders

Start date: February 1, 2024
Phase:
Study type: Observational

The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.

NCT ID: NCT06206070 Recruiting - Clinical trials for Autism Spectrum Disorder

The Westmead Feelings Program Intervention for Chinese Children With Autism Spectrum Disorder in Hong Kong

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The goal of this intervention is to evaluate the effectiveness of delivering the Westmead Feelings Program 2 to children with Autism Spectrum Disorder in primary schools in Hong Kong.

NCT ID: NCT06196060 Recruiting - Clinical trials for Autism Spectrum Disorder

Improving ToM in Children With ASD Through VPT Training: Behavioral and fNIRS Study

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

This study aims to employ a longitudinal tracking research to investigate the effects of a visual perspective taking intervention on the development of theory of mind in children with autism. Additionally, the investigators seek to examine modifications in the neural mechanisms linked to facial emotion recognition in children both before and after intervention by using the functional Near-Infrared Spectroscopy (fNIRS) to record the relative changes in blood oxygen levels in the cerebral cortex with the oddball Face-Periodic Visual Stimulation (FPVS) paradigm.

NCT ID: NCT06187090 Recruiting - Clinical trials for Autism Spectrum Disorder

The Supplementation Therapy in Autism and Response to Treatment Study

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Start date: September 1, 2023
Phase: N/A
Study type: Interventional

In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and/or anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds. The aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical/food supplement with proven anti-inflammatory and neuroprotective properties. Indeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and/or neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis. The trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet/day. This study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital. Through this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and/or depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning. The study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant will be on PEA treatment for up to 36 weeks. During the course of the study, periodic clinical re-evaluations will be conducted at our Day-Hospital setting. The trial will unfold through one screening visit, one baseline visit, and two follow-up visits (FUP, 4 weeks and 12 weeks apart). The patient will be administered standardized interviews by a qualified investigating physician; clinical objective examination, collection of blood and urine samples for standard hematochemical investigations, collection of blood and stool samples for analysis of some biological markers of interest, monitoring of adherence to therapy intake, side effects, and adverse effects will also be performed during the follow-up visits. The nutraceutical PEA will be dispensed by the clinical investigators at each follow-up visit.

NCT ID: NCT06184802 Recruiting - Clinical trials for Autism Spectrum Disorder

Multisensory Room in Autism Spectrum Disorder

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

Autism spectrum disorder (ASD) is a complex neurological development with onset in infancy or early childhood. Atypical sensory processing has been widely reported in ASD, and recent literature suggest that this abnormality extends across the life span, with consequent important implications in every-day life of autistic individuals and their families. Multisensory environments have been used in children with ASD precisely as a function of this particular difference in sensory processing and some studies have highlighted potential benefits. Therefore, the aim of our study is to verify feasibility and efficacy of an integrated treatment program with the multisensory room compared to as usual treatment in patients with ASD.

NCT ID: NCT06181864 Recruiting - Clinical trials for Autism Spectrum Disorder

Emotional Regulation in Individuals With Autism

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

The objective of the study is to learn about and manage emotions such as anxiety and anger. The activities are aimed at identifying and managing emotions such as anxiety and anger, through the recognition of the changes that occur at a physiological, cognitive, behavioral and communicative level. In the first sessions, children will be exposed to the emotion of happiness through pleasant activities and involved in relaxation exercises. In subsequent sessions, anger and then anxiety will be addressed first. Social tools will be introduced and ways of thinking and perspective useful to children will be addressed. Furthermore, they will learn to use all the tools and strategies necessary to face and overcome the various emotions and situations in a functional manner. In the final sessions, children will work to design a cognitive-behavioral intervention program for themselves and other group members to improve the management of anxiety and anger. The expected results concern the acquisition of adequate emotional regulation; the construction of functional thoughts, social tools, thinking and perspective tools, adequate strategies for managing emotions; the design of a cognitive-behavioral intervention program in daily life and the strengthening of relational, social, empathic and resilient skills within the peer group and families.

NCT ID: NCT06179953 Recruiting - Clinical trials for Autism Spectrum Disorder

Emotional Skills Training With Social Robot

Start date: June 5, 2023
Phase: N/A
Study type: Interventional

Autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns. In particular, emotional regulation is a central developmental skill. In fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time. Therefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (ASD). The children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.

NCT ID: NCT06179940 Recruiting - Clinical trials for Autism Spectrum Disorder

Food Selectivity Protocol for Children With Autism Spectrum Disorders

Start date: November 23, 2023
Phase: N/A
Study type: Interventional

Food selectivity is a common challenge among children with Autism Spectrum Disorder (ASD), with significant impacts on their nutrition and well-being. The main purpose of this study is to promote children's active participation in mealtime routines and encourage experimentation with new foods through an approach that emphasizes joy and serenity during mealtimes. The study will involve children with ASD between the ages of 4 and 10 years, of both sexes. Food selectivity will be assessed through interviews with parents and the use of specially created cards. The protocol will include 45-minute sessions, twice a week, for a total of 48 sessions. During these sessions, two plates, a list of foods previously agreed upon with the parents, and the foods needed for each session will be used. The sessions will take place in an environment called "Home Lab"a specially set up as if it were a kitchen to reproduce a home atmosphere.

NCT ID: NCT06179927 Recruiting - Clinical trials for Autism Spectrum Disorder

Group Intervention on Theory of Mind in Children With Autism Spectrum Disorder.

Start date: October 16, 2023
Phase: N/A
Study type: Interventional

The project involves the participation of 40 children with Autism Spectrum Disorder of both sexes, aged between 6 and 10 years. The subjects will undergo a pre-intervention evaluation phase, which will consist of administering the Theory of Mind (ToM) test present in the NEuroPSYcology second edition (NEPSY) battery, part A. The same test will be administered again at the end of the intervention. Once the inclusion criteria have been met and following the randomization of the sample, divided into Experimental Group (EG n=20) and Control Group (CG n=20), the administration of the search task will proceed. The study involves 12 sessions, one per week, lasting 45 minutes. The EG will view twelve social scenes created through a tablet. In the scenario, the depictions will be presented in color. Guided by the narrating voice of QT Robot, they will have to choose between two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, an audio-visual feedback will be provided, through the robot, to give the subject information about the accuracy of their response. In both groups, a simple instruction will be given to the child, telling them to pay attention to the story that will be narrated and then answer simple questions. In the EG, QT robot will speak, while in the CG it will be the operator. The prompts will be related to the accuracy of the response or they will rather be aimed at encouraging the child to give the correct answer.