Autism

This 24-month study is testing whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy helps improve autism symptoms in children ages 3-12 more than glutathione alone. Children will be randomly placed into one of two groups for the first three months: one group receives glutathione only, and the other receives glutathione plus monthly intravenous AdiaVita infusions. Both groups also use topical glutathione cream twice daily at home. Autism symptoms will be tracked over two years using the Autism Treatment Evaluation Checklist (ATEC) filled out by parents and by therapists or teachers. Safety, side effects, quality of life, and overall well-being will be closely monitored through regular clinic visits, physical exams, blood tests, and adverse event reporting. After the initial three-month phase, children who received glutathione alone may cross over to receive AdiaVita infusions at no additional cost if safety checks at month 6 are satisfactory. Approximately 100 children with a confirmed autism diagnosis from the Central Florida area will take part. Participation is completely voluntary, and families may withdraw at any time.

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.

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH....

This study will examine whether visiting the National Taiwan Museum can support the social and emotional well-being of autistic adults. The research team plans to recruit 90 autistic adults aged 18 to 50 from the Department of Psychiatry at National Taiwan University Hospital. Participants must have average-range intellectual ability and be able and willing to complete the study activities and assessments. People with serious physical or mental health conditions that would prevent full participation will not be included. Participants must also agree to audio and video recording during the activities. After an outpatient doctor confirms eligibility, participants will complete questionnaires and choose one of three museum participation options: 1. Visit the museum once independently. 2. Join five guided museum visits with group discussions. 3. Invite a friend to visit the museum together. Each group will include about 30 participants. For the guided group, each session will last about 90 minutes and include a professional museum tour, a question-and-answer period, time for independent exploration, and a group discussion. Participants will be encouraged to select exhibits that interest them, record their observations, share their thoughts, listen to others, and respond to different viewpoints. The five planned museum themes include Taiwan's history and identity, relationships between people and nature, architecture and living spaces, human evolution and the future, and attitudes toward money and financial planning. The discussions will explore everyday topics such as stereotypes, personal values, preferred living environments, hopes for the future, and managing money. Participants will complete questionnaires before and after the program. These questionnaires will assess areas such as autistic characteristics, social communication, empathy, sensory experiences, comfort with social touch, emotional skills, loneliness, anxiety, depression, and anxiety during social interaction. Participants will also rate how enjoyable, comfortable, safe, interesting, and socially engaging they found the museum activities. The researchers will compare participants' results before and after the program. They will also compare the three participation options to determine whether independent visits, guided group activities, or visiting with a friend produce different outcomes. The overall goal is to understand whether museum-based activities can be used as a form of social prescribing to improve social participation, emotional well-being, confidence, and quality of life among autistic adults.

The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are: 1. Is the Power Down feasible for caregivers to do each night? 2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?

This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.

The goal of this study is to learn if a dance, yoga, and mindful movement program can improve the lives of adults with autism spectrum disorder (ASD). ASD is a condition that can affect how a person communicates, connects with others, and experiences daily life. This study focuses on adults ages 18 to 35. The main questions it aims to answer are: * Can a dance, yoga, and mindful movement program improve social skills and communication for adults with ASD? * Can it improve their quality of life and sense of well-being? * Can it improve their physical, mental, and emotional health? Dance, yoga, and mindful movement have been studied in children with ASD, but very little research has looked at how they may help adults. This study hopes to help fill that gap. Participants will: * Take part in a 12-week dance, yoga, and mindful movement program * Answer survey questions at the start and end of the program about their social skills, communication, quality of life, well-being, and overall health

BRIEF SUMMARY A. "What is the purpose of this study?" This study will test whether the "AI City Hall Project" (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called "Microcities". Researchers want to see if AI-managed public administration, AI humanoid robots, holoportation of human-figures via 'holo-suites' (e.g., AI-119 Kikkeri Holo-Suit; AI-119 Vulcan QM-Ware) and advanced AI mental-health tools can lower housing and care costs, improve mental health outcomes (e.g., particular ecosystems using AI tools among persons with one or more addiction disorders), and be financially sustainable for people on fixed incomes or public assistance. B. "What conditions does the study focus on?" The study focuses on adults with: * Autism spectrum disorders (Asperger's, autism, ADHD, ASD) * Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA/ecstasy, tobacco/nicotine) * Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders) * Behavioral addictions (gambling, sex addiction) and related issues (sex offence history). C. "What does the study involve?" Eligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital "attitude inoculation" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic. \*\*Who can participate?\*\* You may be able to join if you: * Are an adult (18 years or older) * Have a diagnosis of one of the listed mental-health or addiction disorders * Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organisation (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole/probation officer, judge) * Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses. Participants who are veterans, receive public assistance (e.g., VA disability, SSDI/SSI, Medicaid, Medicare), or are experiencing homelessness may be prioritised. \*\*Where is the study taking place?\*\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones. \*\*Who is sponsoring the study?\*\* The study is sponsored by \*\*Veterans Recovery Network Inc.\*\*, a non-profit organization, in collaboration with \*\*AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO)\*\* and an AI legal agency. The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §129a) and is part of a Cooperative Research and Development Agreement (CRADA) with U.S. Special Operations Command (USSOCOM). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

Autistic toddlers often need support to develop both social-communication and social-emotional skills. Social communication (such as making requests or sharing attention) is usually addressed in early intervention, but social-emotional needs (such as expressing feelings or learning to cope with frustration) are often overlooked. Both are important for children's development and for preventing challenging behaviors. This study is testing a blended intervention designed to support both areas at the same time. The program combines Project ImPACT, a caregiver-mediated social communication intervention, with universal practices from the Pyramid Model, a national framework for promoting young children's social-emotional development. Caregivers of autistic toddlers will be coached by early intervention providers to use strategies during everyday routines and play. The study will enroll 40 caregiver-toddler pairs, randomly assigning them to one of four study conditions. Families assigned to the waitlist control group will receive the intervention after a delay. The goal is to understand whether this blended approach improves toddlers' communication and emotional development, and whether caregivers find it helpful and practical in daily life. Because many states and early intervention systems already use the Pyramid Model, this study could provide a way to make those programs more inclusive of autistic children and their families.

This is a 20-week study for children between 3 and 6 years old with confirmed childhood apraxia of speech (CAS). The study includes a 12-week open-label pilot feasibility study of an investigational drug (Omega-DEK) plus L-carnitine (Carnitor®), which is followed by an 8-week randomized, placebo-controlled discontinuation period among the same study participants.

There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.

The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.

This study evaluates the efficacy of the Companion Mind-Drawing Cooperative Game Program, a parent-mediated, home-based structured play intervention targeting social cognitive development in young children with autism spectrum disorder (ASD). Children with ASD in the intervention group will receive a structured program in which parents attend an in-person training session (approximately 2.5 hours) at the hospital, where parents are taught to administer a series of researcher-designed cooperative game paradigms at home. Parents then deliver the intervention daily for at least 30 minutes per session over a period of six months. Monthly online video reviews by a clinician provide parents with individualized feedback and guidance to ensure program fidelity and quality. Children with ASD in the comparison group will continue to receive usual care and will not receive the program during the study period. Social cognitive outcomes - including emotion recognition, theory of mind, empathy, joint attention, self-perception, and social communication - will be assessed at baseline and at 12-month follow-up using behavioral experimental tasks and eye-tracking paradigms. This study aims to provide evidence for the efficacy of a scalable, family-implemented social cognition intervention for young children with ASD.

The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).

Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.

This pilot study is funded by the Organization for Autism Research (OAR). We are conducting a pilot study to improve mental health treatment for autistic individuals. First, we will conduct remote focus groups to identify barriers to mental health treatment and methods to improve treatment. Based on results, we will develop a prototype of a resource for therapists. This resource will be pilot tested in a community clinic.

The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT). The study will include boys and girls 2 to 4 years 11 months old diagnosed with ASD. The main questions this study aims to answer are whether center-based ESDM and center-based PRT improve communication skills in young children with autism, and whether certain children respond better to one treatment approach than the other. Participants will be randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attend treatment session 4 days per week (\~3 hours/day), complete developmental and autism assessments at baseline, 12 weeks, and 24 weeks, have a parent participate in weekly parent training sessions, and complete follow-up assessments at weeks 36 and 48.

Obesity is one of the most common health conditions among autistic young people and its prevalence rises at faster rates for autistic-relative to non-autistic-individuals. This places them at heightened risk for cardiovascular disease (CVD) and mortality before they enter adulthood. Studies have identified three key contributing factors to CVD outcomes in autistic individuals: unhealthy lifestyle behaviors, Adverse Childhood Experiences (ACEs), and chronic stress. This study will explore the effectiveness of two CVD-focused primary care interventions for autistic individuals (ages 9-26): (1) lifestyle medicine consultations tailored towards supporting health-promoting behaviors; and (2) a Cognitive Behavioral Therapy (CBT) intervention tailored towards addressing chronic stress that contributes to excess weight and maladaptive eating behaviors and results in obesity and CVD. Participants and their caregivers will be randomly placed into either the Lifestyle Medicine Group, CBT Group, or combined Lifestyle Medicine with CBT Group. Participants will respond to questionnaires and surveys measuring lifestyle habits, stress, and psychological risk factors at their first visit, 6-month visit, and 3 months post-intervention visit. Over the course of 6 months, participants will attend virtual sessions (up to three times a month) in accordance with their intervention group.

The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.

The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).

Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.

The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Its playful and motivating features, together with the possibility of tailoring task difficulty and delivering intensive training in a controlled environment, make VRRS a promising intervention for children with autism spectrum disorder (ASD), who frequently present weaknesses in visual attention, executive functioning, and visuospatial memory. This randomized controlled trial aims to evaluate the efficacy of a VRRS-based cognitive training program in improving visual attention, executive functions, and visuospatial memory in children with ASD, compared with an active control intervention based on conventional cognitive training. Children aged 4 to 6 years 11 months with ASD, non-verbal IQ \>70, and no severe neurological or sensory comorbidities will be enrolled and randomly assigned to the experimental or control group. The intervention will consist of two 45-minute sessions per week for 12 weeks. VRRS training will include individualized tasks targeting the selected cognitive domains, with adjustable difficulty, execution time, and repetitions. Assessments will be conducted at baseline (T0) and post-intervention (T1). At baseline, non-verbal cognitive functioning will be assessed using Leiter International Performance Scale, Third Edition (LEITER-3), while attention, executive functions, and visuospatial memory will be measured using Preschool Executive Functions Assessment Battery (FE-PS), LEITER-3 attention and memory tasks, Developmental Neuropsychological Assessment - Second Edition (NEPSY-II) (Memory for Designs), and Behavior rating inventory of executive function-preschool version (BRIEF-P). The same battery will be repeated after training to compare pre- and post-intervention scores and estimate the relative efficacy of the two approaches. It is hypothesized that children receiving VRRS-based training will show greater improvements in the targeted cognitive functions than those receiving conventional training, supporting the clinical utility of virtual reality as an effective and engaging rehabilitation approach for children with ASD.

Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.

Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure" used in a Culturally and Linguistically Responsive adaptation of Pathways Early Intervention (CLR-Pathways) is the key to improving social communication, language, and everyday skills in young (18-42 months) Hispanic autistic children experiencing low income. What Will Happen: Researchers will compare two versions of CLR-Pathways. * Version 1: Includes mutual gaze strategies. * Version 2: Does not include mutual gaze strategies. What to Expect: Participants will: * Attend 16 sessions (or 18 weeks if there are cancellations) of Pathways Intervention, each lasting 1.5 hours. * Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.

The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is: To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.