Autistic Disorder

7

Review clinical trials related to Autistic Disorder. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 32
Trial details
Phase: Early Phase 1Age: 18-50Biological sex: MaleType: InterventionalSponsor: Christopher John McDougle, M.D.Updated: May 12, 2026Locations: 1
Eligibility criteria

18 to 50 years of age (inclusive) and assigned male at birth. [+12]

DSM-5-TR diagnosed ASD, level 1, or presence of another DSM-IV-TR diagnosed perv... [+16]

Status: Recruiting

Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders

Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have been made. Research has shown that individuals with FXS process sounds differently than those in the typical population, and they also show baseline differences in brain activity, including high gamma activity, increased theta activity, and decreased alpha activity. The investigators' central hypothesis is that these alterations in brain activity (specifically alpha and gamma activity) impair the brain's ability to process new information, thereby impeding cognitive functioning and increasing sensory sensitivity. The investigators propose that auditory entrainment, a technique that involves playing special sounds through headphones, will normalize brain activity in individuals with FXS and lead to increased cognitive function and decreased sensory hypersensitivity.

Participants needed: 180
Trial details
Age: 5-10Biological sex: AllType: InterventionalSponsor: Children's Hospital Medical Center, CincinnatiUpdated: Mar 30, 2026Locations: 1
Eligibility criteria

FXS Cohort: 1) Aged 5-10 years, inclusive; 2) Patient has full FMR1 mutation con... [+2]

All subjects: 1) Patient has auditory or visual impairments that cannot be corre...

Status: Recruiting

Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)

The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.

Participants needed: 188
Trial details
Age: 18-42Biological sex: AllType: InterventionalSponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Updated: Mar 24, 2026Locations: 1
Eligibility criteria

Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderate conc... [+9]

Having a primary language other than English [+2]

Status: Recruiting

Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder

The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of PennsylvaniaUpdated: Mar 13, 2026Locations: 1
Eligibility criteria

18 years of age or older [+3]

Severe self-injurious or aggressive behaviors; or with suicidal or homicidal ide... [+2]

Status: Recruiting

Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)

Behavioral testing is the gold standard for diagnosing autism spectrum disorder (ASD). These tests, including ADOS and ADI-R, are subjective, require trained staff to administer, are time-consuming, and can only be administered at a later age. Blood-, urine- or stool-based diagnostic biomarker test for ASD would enable objective early diagnosis, potentially even before clinical symptoms are present, eliminate the need for trained staff and enable early intervention. Such a test would not only conserve money and time but would also provide clues to ASD pathogenesis. To date, no definitive treatment exists for ASD. Most therapies are symptom-focused, generally focusing on behavioral, social and communication skills. Recent works have reported on promising outcomes of mesenchymal stem cell (MSC) treatment of children with ASD. MSCs are multipotent, non-hematopoietic, easily isolatable and expandable stem cells involved in tissue repair, immunomodulatory responses and neuromodulation. MSC treatment of children with ASD has reportedly led to improvements in speech, sociability, eye coordination, balance, cognition and overall well-being. At the base of this approach lies the known plasticity of the human brain and immune system in the early childhood years and the ability of MSCs to modulate atypical inflammatory and immune activities. Assessment of ASD biomarker profiles in children with ASD who have undergone one or more SCT sessions may shed light on the mechanism of action, assist in better defining ASD-specific diagnostic markers and monitor treatment outcomes.

Participants needed: 900
Trial details
Age: 10-19Biological sex: AllType: ObservationalSponsor: Benjamin GesundheitUpdated: Nov 25, 2024Locations: 1Duration: 1 Day
Eligibility criteria

Male and female children [+2]

Child and/or mother completed treatment with systemic steroids or immune suppres... [+5]

Status: Recruiting

COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD

Purpose: The purpose of this project is to develop and test the COMPASS \[Collaborative Model for Competence and Success\] Across Settings (CAST) intervention to enhance the goal setting and attainment skills of autistic youth. Despite federal education law mandating transition services as part of the Individualized Education Program (IEP) for ensuring good outcomes for students with disabilities, current educational practices have been unable to demonstrate that autistic students experience positive postsecondary outcomes. There are existing, evidence-based interventions aimed at supporting positive outcomes for these students. However, these interventions have not systematically provided coaching support to the caregivers, students, and employment specialists. To address these issues, CAST will integrate three evidence-based interventions for supporting student transitions while providing this critical coaching support. By doing so, CAST aims to align the priorities and goals of interventions across home, school, and community settings to better support positive postsecondary outcomes for autistic students.

Participants needed: 297
Trial details
Age: 16-99Biological sex: AllType: InterventionalSponsor: Ball State UniversityUpdated: Mar 13, 2024Locations: 1
Eligibility criteria

Students with verified autism and IEPs that designate services for autism [+3]

Not planning to move or leave their job over the school year

Status: Recruiting

SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism

Locomotor, transport and information functions in human body systems are carried out by active media in autowave regimes! Any living organism is a (micro-macro-mega) hierarchy of autowave subsystems-an ensemble of loosely coupled subsystems of a simpler structure. From the highest levels of the hierarchy, Autowave Codes-Signals arrive, which determine the transitions of subsystems from one autowave regime to another Autowave interaction (of Complex Coherent Action). Autowave interaction is a process associated with the evolution and interaction of spatial and wave structures in the active media of the organism. Chaos in organism functioning tells about health. Periodicity - Autowave reverberator may presage a disease - Autism Spectrum Disorder; Chaotic nature of oscillations in active media of physiological systems is more optimal for their vital functions than periodic one. Firstly, systems that function in chaotic regimes, can re-arrange themselves faster and easier in case of change of environmental conditions, i.e. the so called adaptive control is more easily implemented in them. Secondly, "spreading" of oscillations strength along comparatively wide frequency band takes place in chaotic regime. When an organism is young and healthy, physiological systems show the elements of chaotic behavior, i.e. irregularity and chaotic dynamics are the extremely important characteristics of health. Decrease in changeability and appearance of stable periodicity of Autowave reverberator are often connected with Autism. The main purpose is to study brain plasticity (the changes that occur in the brain through Autowave reverberator) in children with autism. Research suggests that during development, the brains of children may change in response to their Autowave reverberator differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of autism spectrum disorder (ASD). In this study, the investigators will be examining the effects of non-invasive neuromodulation SQUED™ series 28.1 home-use for Treatment of Autowave reverberator of Autism. Integrative Team World Organization of Medical Synergetics (WOMS) - collaborations between physicians and researchers with expertise in biostatistics, physics, mathematics, engineering, and computer science.

Participants needed: 80
Trial details
Age: 1-21Biological sex: AllType: ObservationalSponsor: American Federation of Medical SynergeticsUpdated: Nov 28, 2017Locations: 2
Eligibility criteria

Clinical diagnosis of autism or related conditions. [+13]

Peripheral blindness - precludes use of Image converter SQUED™ (iSQUED™). [+3]