Active clinical trials for "Autism Spectrum Disorder"

CLINICAL ISSUE: Children with Autism Spectrum Disorder (ASD) are four times more likely to suffer with functional gastrointestinal disorders (FGIDs) than their neurotypical peers. The presence of FGIDs are linked to increased undesirable behaviour and ASD severity. Current behavioural approaches for ASD therapy do not alleviate the high comorbidity of FGIDs within this population. BACKGROUND: Dysfunction of the microbiome-gut-brain (MGB) axis has been implicated in pathogenesis of both ASD and FGIDs. Probiotics and prebiotics can modulate the gut microbiome and research has shown efficacy at improving gastrointestinal (GI) symptoms in children with ASD and neurotypical (NT) children with FGIDs. Gut-directed hypnotherapy (GDH) has shown utility in treating FGIDs in NT children and adults but has not yet been trialed in children with ASD. Targeting therapies to address the dysfunction of the bidirectional MGB axis will likely be more effective than either brain/behavioural or gut-based therapy alone. HYPOTHESIS: A synbiotic (prebiotic + probiotic mixture) with combined GDH will be more effective than a synbiotic alone at reducing GI symptoms in children with ASD aged 5.00 to 10.99 years over a 12-week period.

The reported social benefits of knitting combined with the urgent need for social and activity-based programs in the disability community suggest that a knitting intervention may fill a substantial gap in available programs. Knitting may also be well suited to autistic strengths, combining sensory aspects (colourful sights, soft touch, rhythmic sounds), visual patterning, and repetitive actions. Surprisingly, no knitting programs for ASD or other conditions are reported in the literature. It is proposed that a knitting group can provide social and skill-building opportunities, improving real-world social outcomes for youth with ASD, and resulting in KneuroKnits, a program designed specifically to serve this need. The program will be designed and run by a collaborative team of clinicians, researchers, knitting experts, and a self-advocate with ASD. This program will enhance evidence supporting programs providing contexts for the dual goals of meaningful social interaction for young people with neurodevelopmental disorders, physical disabilities, and acquired brain injuries and building a real world creative skill that can facilitate social interaction within and beyond the program. This study will evaluate participants' experiences of the program as well as their levels of anxiety at various points during the program.

This study is design to evaluate the efficacy of the Treatment and Education of Autistic and Communication Handicapped Children (TEACCH) on the rehabilitation for preschool children with autism spectrum disorders (ASD) in China.A case-randomized controlled study was conducted.Sixty children diagnosed with ASD between 36 and 90 months of age were randomly assigned to the a TEACCH intervention group or a control group.The control group was subjected to regular rehabilitation training, the TEACCH group carried out TEACCH training besides regular rehabilitation training for 6 months. Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3) was used to evaluate the effectiveness of TEACCH rehabilitation training.

By utilizing community-based participatory research methods, this research was conducted in collaboration with the community through our partnership of researchers, educators, providers and consumers (Active Collaborative Hub for Individuals with ASD to Enhance Vocation and Education- ACHIEVE) to adapt a vocational soft skills program, Supported, Comprehensive Cognitive Enhancement & Social Skills (SUCCESS), for Transition Age Youth (TAY). The first step (years 1-2) involved adapting the intervention for autistic TAY by including feedback from multiple stakeholders and developing a curriculum to be implemented in both High Schools and Transition programs for the specific needs of autistic TAY and alpha piloting it. It involved understanding further the educational context for TAY students and current services available to prepare students for secondary outcomes of employment and/or college through a county wide survey. Step 2 (years 2-3) included pilot testing the feasibility, acceptability, implementation procedures and initial youth outcomes of the TAY SUCCESS intervention and further refining the curriculum and protocols. Findings demonstrated improvements in executive functioning and social functioning targets as well as distal outcomes of self-efficacy, mental health, educational and work behaviors and attitudes. The study results were disseminated through the ACHIEVE group as well as at conferences, website and publication.

Biofeedback is a process that allows people to obtain information about their internal physiological reactions and thereby learn to control them. Researchers studying the brain and nervous system have found that regulating heart rate can help us to relax. Controlling heart rate using biofeedback has been shown in some studies to help people manage symptoms of stress such as anxiety and depression. This research will explore whether biofeedback can help people with autism or Asperger syndrome reduce reported symptoms of stress. Participants with a diagnosis of high functioning autism will be invited to use a biofeedback device that helps them to regulate their heart rate. People who enrol for the study will be randomly assigned different biofeedback devices. Training and support in the use of the device will be provided to participants. Assessment will involve obtaining questionnaire reports from participants and their carers about participant levels of anxiety, depression and sensory symptoms, demographics and lifestyle. These assessments will be carried out at the beginning, in the middle and at the end of the study to see if there are any differences in how each participant's heart rate changes, whether there are any changes in participant's reported symptoms. Participants will be asked to give daily reports on their progress to monitor stress levels, usability of device and dropout rates. The overall aim is to determine whether biofeedback is a way of helping people with autism to reduce symptoms of stress.

This is a single site, prospective study of one intravenous infusion of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in toddlers with autism spectrum disorder (ASD). Toddlers 18 to 48 months of age with a confirmed diagnosis of ASD will be eligible to participate. Diagnosis will be confirmed at the time of the eligibility visit at the Duke Center for Autism and Brain Development. All participants will receive a single intravenous dose of 2x106/kg hCT-MSC per kilogram at baseline. Assessments will be conducted at baseline and 6 months, with remote follow-up assessments at 12 months.

Clinical trials will evaluate the efficacy of expert guiding technology to support instructors to better help individuals with developmental challenges due to ASD and ID learn life and vocational skills. Single Case Research Designs (SCRD) will be used to evaluate expert guiding technology interventions to support Task Analysis. SCRDs are a viable alternative to large group studies such as randomized clinical trials. Single case studies involve repeated measures, and manipulation of an independent variable. SCRD studies allow for rigorous experimental evaluation of intervention effects and provide a strong basis for establishing causal inferences. Research design: A multiple baseline across tasks or participants will be used to evaluate the impact of the expert guiding technology on staff and consumers' performance. Dependent Variables. DV1: Staff performance: The percentage of teaching steps correctly implemented will be calculated and monitored. The teaching steps are predetermined including what types of prompts will be used for each step of the task analysis of the identified consumer's adaptive living skills, record data on consumer's performance, and the timing of delivery of reinforcers and prompts. DV2: Consumers' performance: The percentage of Independent completion of the steps of task analyses for identified daily living skills will be calculated and monitored. The completed step is considered "independent" when the consumer completed the step without prompts from the staff within five seconds of the initial instruction (discriminative stimulus) given or the completion of the previous step. DV3: Consumers' performance: the amount of time taken to independent completion. Independent Variable: Versions of expert guiding technology to support instructors in providing Task Analyses instruction while collecting data on consumer performance. GAINS: During the GAINS sessions, the staff will follow the pre-programmed teaching protocol in the expert guiding technology. The system will provide step-by-step verbal prompts to the staff throughout the sessions. This includes which prompt to use for each step, when to provide reinforcers, and which target task to work on. The system will also monitor the consumer's progress and notify the staff if the target task is mastered or not.

The purpose of this study is to compare two different treatment approaches to social skills groups for high-functioning children with Autism Spectrum Disorder (ASD). This project will examine changes in both behavior and the brain following treatment.

Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.

Nutritional supplements like vitamin B6 and magnesium have demonstrated to have beneficial effects in patients with autism spectrum disorders (ASD). The underlying theory for these effects is that specific metabolic pathways in neuronal cells, e.g. the methionine cycle, will be more balanced. Most studies have been focused on the clinical outcome with this treatment. The present proposal will examine the effects on the different intermediates of the methionine cycle (methylation and transulfuration capacity), suggested to play an important role for the pathogenesis of ASD. The design is a prospective pilot study, including 40 patients, aged 2-6 yrs, with newly diagnosed ASD. All participants will receive the supplement (vitamin B6, magnesium; Kirkman formula) and placebo in a cross over design. Metabolites in blood and urine will be measured prior to and at the end of the treatments in the different groups. The results will then provide us with information, which will link clinical outcomes with biological markers. Furthermore, the study has also the potential to shed light on the pathogenesis of ASD.