Clinical Research Directory

Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder

The goal of this clinical trial is to learn how prednisone affects adults with autism spectrum disorder (ASD). It will also learn about the safety of prednisone. The main questions it aims to answer are: * How does prednisone affect the core features and associated target symptoms of ASD in adults with an immune-mediated subtype of ASD? * Is prednisone safe for autistic adults without causing too many side effects? * Does this study warrant larger trials studying anti-inflammatory drugs in this subject population? Researchers will compare the drug prednisone to a placebo (a look-alike substance that contains no drug) to see how prednisone affects autistic adult males. Participants will: * Visit the clinic 2 times for a screening and baseline visit. * Take prednisone or a placebo every day for 16 weeks. * Visit the clinic 2 times for checkups, tests, questionnaires, and dose changes, and 1 time for a follow-up visit 4 weeks after stopping the study drug. * Provide blood and urine samples for testing up to 4 times. * Complete 8 remote calls every 1-2 weeks for checkups and dose changes. * Keep a diary of the dose and times they take the study drug every day and any symptoms or side effects they experience.

Pilot Study on Collaborative, Comprehensive, Multidimensional and Quality of Life Tools for Priority Definition, Shared Decision Making, Outcome Evaluation and Quality of Care Improvement in ASD Individuals and Programs in the Real World.

ASD is a very complex and lifelong disorder. Patients' functioning is influenced by multiple factors, including treatments, inclusion and life contexts. Nonetheless, outcome measures are still point-specific and highly fragmented, rarely considering global or multidimensional functioning, development or long-term modifications, especially in the real world. The present study considers ongoing real-life treatments in three different NHS settings, in line with the Italian Guidelines. Two age classes will be considered, 0-5 and 6-11, adding new outcome tools pre-post intervention to those already used, to evaluate quality of life, global functioning, multidimensional needs and strengths and shared decision making. Correlations between the different outcome tools will be explored, and possible clusters will be investigated. Acceptability of the outcome tools for the operators, patients and families, as well as usefulness and sustainability in daily practice, will also be evaluated.

Project AFECT (Autism Family Empowerment Coaching and Training Program)

The goal of this clinical trial is to learn about the journey of families after their child's diagnosis of autism and to help parents understand autism and get the right treatments for their child. This study is for parents of children just diagnosed with autism who are: * Age greater than 1 and up to 5 years old; * Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND * Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma). The main questions it aims to answer are: * Whether parent coaching through Project AFECT leads to decreased parental stress and increased parental confidence; * Whether family navigation through Project AFECT leads to increased number of referrals to early intervention and educational services and reduced wait times to autism treatments; * Whether children whose parents receive Project AFECT intervention show increased language skills compared to children whose parents did not receive intervention. Participants will be asked to: * Complete surveys at enrollment and 3 and 6 months later. * Work with Project AFECT Coach. Researchers will compare control and intervention groups to see if Project AFECT leads to improved parent and child outcomes.

Phenotypic and Genetic Factors in Autism Spectrum Disorders

The purpose of the study is to collect phenotypic (observable characteristics) and genetic information about individuals with Autism Spectrum Disorders (ASDs) and their families.

Water Competency Intervention in Autism

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.

Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus

Difficulties in social interactions are the core feature of autism spectrum disorder (ASD) and are characterized by abnormal social perception, mainly concerning eye gaze. Anatomo-functional abnormalities within the superior temporal sulcus (STS), a key region of the social brain, have been described in ASD. The investigators had recently shown that it is possible to modulate the neural activity of the STS with transcranial magnetic stimulation (TMS) with an impact on social perception, measured by eye-tracking. In the context of ASD, stimulation of the STS with excitatory TMS could lead to an improvement in social perception, which would open up new therapeutic strategies. The purpose of this double-blind, randomized, placebo-controlled study is to apply a therapeutic TMS protocol (10 daily sessions) at the right STS in young adults with ASD to improve their social behavior, objectively measured using eye-tracking.

Improving Participation of Autistic Children and Adolescents in the Habilitation Process

This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre.

Sensory Supported Swimming for Children With ASD

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.

Intestinal Permeability in Children With Autism Spectrum Disorder

In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Enhanced paracellular permeability ("leaky gut") may allow luminal antigens and microbial metabolites to translocate into the systemic circulation, triggering inflammatory responses that could impact neuropsychological functioning. Several studies suggest that, although intestinal permeability is not universally altered in all individuals with ASD, there exists a subset characterized by selective epithelial dysfunction, especially associated with repetitive and stereotyped behaviors. This project aims to investigate, through a controlled sibling-based design, whether intestinal permeability indices are significantly altered in children with ASD and whether such alterations are specifically correlated with behavioral domains assessed through the ADOS instrument.

Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models

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.

ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders

The objective of the ELENA French Cohort is to study the developmental trajectories of children and adolescents with ASD and their risk or protective associated factors. This is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with ASD recruited from services specialized in the assessment of developmental disorders.

Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders

The goal of this interventional study was to examine the effectiveness and mechanism of online peer companion intervention (OPCI) on the social abilities and mental health of ASD children. The main questions it aims to answer are: 1. Whether OPCI is effective on the social abilities and mental health of ASD children; 2. What impact does OPCI have on the social abilities and mental health of ordinary children; 3. What impact does OPCI have on the mental health of both children's parents; 4. What are the mechanisms of OPCI on ASD children.