Asperger Syndrome is a neurodevelopmental condition characterized by challenges in social and cognitive development, often requiring lifelong support strategies to enhance adaptive functioning and independence. Clinical trials related to Asperger Syn...
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Found 163 Actively Recruiting clinical trials
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Researchers are evaluating an early behavioral intervention program for toddlers aged 16 to 48 months who are waiting to receive a formal autism diagnosis. The study aims to address delays in autism diagnosis and intervention by offering caregivers access to a self-directed online training resource during the waitlist period. This approach seeks to empower parents to support their children's development early, potentially reducing the harms associated with waiting for diagnosis and intervention services. Participants will be randomly assigned to either receive access to the "Online Parent Training in Early Behavioral Intervention" (OPT-In-Early) program or be placed on a waitlist without intervention for six months. The OPT-In-Early program includes 14 modules (6 mandatory and 8 optional) with text and video materials teaching caregivers strategies to improve language, social, and adaptive skills and reduce disruptive behaviors. Parents can also schedule brief support calls with a clinician for guidance during the intervention period. After six months, waitlist participants will gain access to the program, but outcomes will not be measured for them. Throughout the study, caregivers complete assessments including individualized goal setting with video recordings to capture their child's current skills and progress. Standardized measures of adaptive behavior, parental stress, and autism-related challenges are collected at baseline and after six months. Researchers will monitor program engagement using website usage data and support call frequency. The primary outcome is change in goal attainment as measured by Goal Attainment Scaling, with additional measures assessing adaptive functioning and parental well-being. The total participation time is six months, during which families receive ongoing support and data collection.
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Researchers are evaluating a new tablet game-based tool designed to assess neurodevelopment in young children aged 3 to 8 years. This study aims to determine if the game can accurately distinguish between typically developing children and those with neurodevelopmental disorders such as ADHD, Autism Spectrum Disorder, Specific Learning Disorder, or Communication Disorder. It also seeks to assess how valid and reliable the game-based assessment is for evaluating a child's neuropsychological functions. Participants will complete the tablet game-based assessment, which evaluates attention, memory, language, motor skills, executive functions, and social-emotional abilities. Parents or caregivers will fill out a demographic questionnaire and the Adaptive Behavior Assessment System, Third Edition (ABAS-3), to provide additional developmental information. Some children may be asked to repeat the game assessment about two weeks later to check the consistency and validity of the tool. Children's involvement includes playing the game-based assessment and having their caregivers complete questionnaires about their development and background. The study will measure diagnostic accuracy, validity, internal consistency, predictive validity, and safety of the assessment over a period of 16 months. Researchers will also collect preliminary normative data, evaluate the acceptability of the tool, and assess test-retest reliability to ensure the assessment's usefulness and safety throughout the study.
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Researchers are studying adolescents and young adults with autism spectrum disorder (ASD), a condition marked by difficulties in communication, social skills, and repetitive behaviors. The study aims to understand how a brain stimulation technique called transcranial direct current stimulation (tDCS) might reduce symptoms like anxiety and impulsivity. The research also seeks to use brain activity data and clinical information to predict who will respond well to this treatment. Participants will receive active tDCS for 10 sessions over two weeks, one session per day on working days. During each 20-minute session, they will perform exercises designed to improve processing speed and executive function while receiving brain stimulation. After treatment, participants will be classified as responders or non-responders based on improvements in social responsiveness scores. Throughout the study, participants will undergo various assessments including behavioral scales, cognitive tests, and neurophysiological measurements at the start and after the treatment period. Researchers will track changes in social communication, repetitive behaviors, and brain function. This will help determine the effects of tDCS and identify characteristics that predict treatment response, with the total study duration extending up to the final follow-up in 2026.
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This research aims to evaluate the feasibility of a parent-child yoga intervention designed to reduce attention deficits in children aged 4 to 6 years with congenital heart disease (CHD). Children with CHD often face neurodevelopmental challenges, including a higher risk of attention deficit hyperactivity disorder (ADHD). This study is a preliminary step before conducting a larger randomized controlled trial (RCT) to test the effectiveness of this intervention in improving attention and long-term academic and psychosocial outcomes for these children and their families. The study is a single-blind, two-center, two-arm randomized feasibility trial involving 24 parent-child pairs. Participants will be randomly assigned in a 2:1 ratio to either an 8-week parent-child yoga program plus standard clinical care or standard clinical care alone with a waitlist option for yoga after the study. The yoga sessions last 45 minutes each week and include active and calming parts embedded in stories suitable for the child's developmental level. Parents and children will also be encouraged to practice 5-minute at-home exercises three times a week throughout the 8-week period and continue up to a 6-month follow-up. Participants will undergo three neurodevelopmental assessments: before the intervention, immediately after, and six months later. The study will monitor recruitment, dropout, and adherence rates; acceptability of randomization; variation in yoga delivery; and data completeness. These measurements will help determine the feasibility of the procedures and inform the sample size for the future full-scale RCT. Overall participation spans about eight months including the intervention and follow-up periods.
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Researchers are studying a birth cohort of infants to understand how allergies might be linked to neurodevelopmental disorders such as autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), and learning disabilities. The study aims to identify factors in early life that influence these neurodevelopmental outcomes using standard diagnostic criteria (DSM-5). This observational study is led by Qilu Hospital of Shandong University and focuses on children living in Jinan City and nearby areas in China. Infants in the study are divided into two groups based on allergy status: an allergic group and a control group without allergies. They will be followed for up to six years, with periodic collection of biological samples like blood, urine, and feces. Growth measurements such as height and weight, along with developmental assessments like the GESELL test, will be recorded during regular follow-ups. Participants will undergo evaluations to monitor for signs of ASD, ADHD, or learning disabilities over the study period. Researchers will gather data through questionnaires and clinical examinations at multiple time points from 2023 to 2029. This long-term follow-up helps assess how early-life allergies may affect neurodevelopment. The study provides ongoing monitoring but does not involve any treatment interventions.
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Researchers are studying a strength-based employment program designed to help young adults on the autism spectrum improve their job maintenance skills. This program focuses on using individual strengths rather than correcting deficits, responding to the autism community's call for more positive and holistic approaches. The study aims to evaluate how effective this approach is in improving work satisfaction and the ability to keep jobs among young adults with autism. Participants in the study are randomly assigned to one of two groups: one group receives the strength-based training called KF-STRIDE® Into Work!, which consists of 10 web-based sessions lasting about 60 minutes each, delivered once or twice a week. The other group continues with their usual services and regular activities without the additional intervention. This randomized, single-masked study compares the outcomes between these two groups. Throughout the study, participants complete various assessments before and immediately after the intervention period of seven to eight weeks. These include questionnaires about employment, self-efficacy, strengths use, flourishing, resilience, work satisfaction, and self-esteem. Researchers also gather participant impressions of change and evaluate job search skills. The study monitors these measures to understand the program's impact on job maintenance skills in autistic young adults.
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Researchers are evaluating the use of Esomeprazole to address social communication difficulties in children diagnosed with Autism Spectrum Disorder (ASD). This study focuses on children aged 2 to 6 years and aims to understand how Esomeprazole might impact core symptoms of autism, including social behavior challenges and repetitive behaviors. The trial is a phase 2, 12-week open-label study inviting 25 children to participate. Participants will receive Esomeprazole based on their body weight. Children weighing less than 20 kg will take 10 mg once daily for 8 weeks. Those weighing 20 kg or more will start with 10 mg once daily for 4 weeks, then increase to 20 mg once daily for the next 4 weeks. The study does not include a placebo group, and all participants receive the active medication during the open-label period. Throughout the study, children will be assessed at the start, 4 weeks, and 8 weeks using tools like the Social Responsiveness Scale, 2nd Edition (SRS-2), to measure changes in social communication, and the Aberrant Behavior Checklist, 2nd Edition (ABC-2), to evaluate behavior changes. Caregivers will provide ratings, and children must be able to attend clinic visits regularly. The study includes safety monitoring and aims to collect data on the effects of Esomeprazole over the 12-week period.
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This research aims to evaluate the effects of specialized employment support programs for adults with autism spectrum disorder (ASD), focusing on improving steady employment and overall benefits to their workplaces. The study compares Stanford University's Neurodiversity at Work (NaW) Program to traditional vocational rehabilitation approaches. The goal is to better understand factors that contribute to successful employment and quality of life (QoL) for adults with ASD, potentially advancing supportive programs in the workplace and beyond. Participants are randomly assigned to one of two groups. One group receives a 6-week pre-employment training followed by ongoing support from a team manager, peer mentors, counselors, and coaches starting at onboarding and continuing for 12 weeks. The other group receives typical orientation with delayed support starting 6 months after onboarding. Both groups have managers and coworkers trained to better support employees with ASD. Throughout the study, participants will complete behavioral assessments and quality of life questionnaires at various points, including before onboarding and up to 18 months afterward. Key measures include job retention rates, duration of sustained employment, costs related to employee turnover, rates of job offers, and the World Health Organization Quality of Life assessment. The study also tracks burnout, job satisfaction, organizational support, and work motivation to gain insights into long-term employment outcomes and well-being for adults with ASD.
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Researchers are evaluating whether adding AdiaVita, a product derived from umbilical cord blood stem cells and exosomes, to glutathione therapy can better improve symptoms of Autism Spectrum Disorder (ASD) in children aged 3 to 12 compared to glutathione alone. The study is designed as a 24-month research trial involving about 100 children with confirmed ASD diagnoses. The main goal is to observe changes in autism symptoms using the Autism Treatment Evaluation Checklist (ATEC) at six months, with additional focus on safety, quality of life, and overall well-being. Participants are randomly assigned to one of two groups for the first three months: one group receives glutathione alone, and the other receives glutathione plus monthly intravenous infusions of AdiaVita. Both groups use topical glutathione cream twice daily at home. After three months, children initially receiving only glutathione may switch to the combined treatment if safety checks at six months are satisfactory. The study includes physical exams, blood tests, and monitoring for side effects throughout. During the trial, children will have regular clinic visits for assessments including physical exams, blood tests, and adverse event reporting. Autism symptoms are tracked by parents and therapists or teachers using the ATEC at multiple points over two years. Safety and tolerability are closely monitored with immediate attention to any serious adverse events. Participation is voluntary, with secure data handling and ongoing evaluation over the full 24-month period.
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Autism spectrum disorders (ASDs) are complex neuro-developmental conditions characterized by ongoing difficulties in social communication and interaction, along with restricted and repetitive behaviors or interests. These disorders involve inflammatory conditions and immune system dysfunction, which has led researchers to explore cell-based therapies as a potential treatment. This study is a Phase 1 clinical trial focusing on evaluating the safety and effects of stem cells for children with ASD. Participants in the trial receive three intravenous doses of allogeneic Wharton Jelly Mesenchymal Stromal Cells (WJMSC) at a dose of 1 million cells per kilogram of body weight. These doses are administered every two weeks as the treatment approach. The study aims to assess both safety and efficacy over a follow-up period extending to 12 months after treatment. During the study, researchers monitor participants through laboratory tests to evaluate the safety profile of the treatment. They also measure changes in attention and hyperactivity symptoms using the Adult ADHD Self-Report Scale over a 12-month follow-up. The trial involves children aged 4 to 14 years diagnosed with ASD, with regular assessments and follow-up visits scheduled throughout the year to observe treatment effects and ensure participant safety.
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