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Autistic Disorder clinical trials

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NCT ID: NCT04484077 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

hCT-MSC Infusion in Adults With Autism Spectrum Disorder

AIMs
Start date: January 24, 2022
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety and tolerability of a single intravenous dose of Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in adults with autism spectrum disorder (ASD). hCT-MSC is a cell product isolated from umbilical cord tissue. The cells from the cord tissue are processed and expanded in the laboratory and then infused intravenously in a single dose per participant. Participants will be ages 18-35 years, with ASD and a full-scale IQ >70 without an identified genetic cause of autism. Participants will have an in-person baseline visit and remote follow up visits at 6 and 12 months. In addition to the primary endpoints evaluating safety, the study will evaluate changes in social communications skills after hCT-MSC administration.

NCT ID: NCT04358484 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Implementation of Incredible Years for Autism and Language Delay Program in Spain

FS
Start date: January 2, 2020
Phase: N/A
Study type: Interventional

Children with autism spectrum disorders (ASD) usually present coexisting problems in emotion and behavior regulation, similarly as premature children with communication or socialization difficulties. Caring for children with neurodevelopmental difficulties is an important stressor for parents. Therefore, it is essential that families are offered evidence-based interventions at an early stage within the public health service. Group therapy is a cost-effective intervention that can help parents of children diagnosed with autism and those born prematurely. The Incredible Years - ASLD program is an example of this sort of therapy, consisting of a group intervention for parents of preschool children with a diagnosis of ASD or Language Delay. In Spain, group interventions for children with ASD and preterm children presenting with Language Delay are scarce in the public health service. The Incredible Years - ASLD program has not been translated into Spanish and it has not been previously implemented in our country. The Incredible Years - ASLD group intervention will be carried out in three public Healthcare centers. It is intended to recruit 72 patients diagnosed with ASD or premature children with communication or socialization difficulties, which will be randomized to an Intervention Group or to Treatment as Usual (TAU) Group. The Intervention Group will receive fourteen sessions of the Incredible Years - ASLD program in addition to Treatment as Usual (TAU). In terms of clinical implications, this randomized pilot study could demonstrate the feasibility of implementing this intervention in the regular clinical settings within the Spanish public health service and could be a first step for future controlled studies that demonstrate its effectiveness.

NCT ID: NCT04349644 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Enhancing Social Competence in Adults With Autism

Start date: October 21, 2020
Phase: N/A
Study type: Interventional

SENSE Theatre®, combines several well-documented, effective behavioral strategies, such as the inclusion of trained peer models, theatre play techniques involving predictable (i.e., scripted) and flexible (improvised) role-play, and repeated performance of newly learned skills resulting in greater automaticity of behavior. The intervention has the potential to enhance social cognition and behavior in adults with autism spectrum disorder.

NCT ID: NCT04295746 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of a rehabilitation intervention for people with Autism Spectrum Disorder through an individualised serious game developed for improving skills related to a specific daily living activity: shopping in a supermarket.

NCT ID: NCT04242355 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder

TMSinASD
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

This study will evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in Autism Spectrum Disorder (ASD). Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and an EEG (electroencephalogram) and eye-tracking session to measure neural and visual attentional social response before and after administration of TMS.

NCT ID: NCT04182633 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

MTT for Children With ASD Who Have Gastrointestinal Disorders

Start date: November 15, 2019
Phase: Phase 2
Study type: Interventional

The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating children with Autism Spectrum Disorder (ASD) and gastrointestinal problems (primarily constipation and/or diarrhea). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by a bowel cleanse, followed by 12 weeks of Fecal Microbiota (FM).

NCT ID: NCT04173663 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Advocating for Supports to Improve Service Transitions

ASSIST
Start date: January 3, 2020
Phase: N/A
Study type: Interventional

This is a randomized intervention study to develop and test the national curriculum of a parent intervention training targeting parent's ability for advocate for services to improve the transition to adulthood for their youth with autism spectrum disorder (ASD). UPDATE regarding COVID-19: Due to social distancing restrictions, the in-person intervention series that began in Winter 2020 was paused in Spring 2020 for Cohort 1 intervention groups (TN and IL). The series resumed in Summer 2020 via synchronous web-conferencing. In response to continued pandemic regulations, ASSIST was permanently moved to synchronous web-conferencing in Fall 2020, and this method was the mode of delivery for all remaining sessions and series at all sites (TN, IL, WI). The remaining baseline data was also moved to remote collection through online interview and questionnaires in Spring 2020. The data collection for all follow ups and check ins (6, 12, 18, 24, and 30 month) were completed through web conference and/or phone calls in addition to online surveys. The final data collection for experimental and control groups from all sites will be complete by Summer 2023.

NCT ID: NCT04047355 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Propranolol for Challenging Behaviors in Autism

Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

Severe challenging behaviors such as aggression and self-injury can cause significant morbidity and decrease the quality of life for individuals with Autism Spectrum Disorders (ASD). There are only two medications (Risperdal and Abilify) rigorously studied and FDA-approved for the treatment of irritability in individuals with ASD. These medications are not always successful and have many short and long-term side effects. Well-designed studies demonstrating efficacy and safety of alternative medication treatment choices are needed. There is preliminary evidence that high-dose propranolol can be effective in individuals with ASD who display severe aggression and have not responded to antipsychotics or mood stabilizers. Concerns regarding the safety of high dose propranolol have limited its clinical application. Well-designed clinical trials demonstrating the efficacy and safety of high dose propranolol will have significant effects on clinical practice and improve the physical and behavioral quality of life for an underserved subset of individuals with ASD. This study will pilot the safety and efficacy of high dose propranolol. The investigators will randomly assign participants to either propranolol or to placebo later crossing each participant over to the other group. As propranolol can cause changes in blood pressure and heart function, each participant will complete initial comprehensive testing to monitor cardiac safety throughout the study. The investigators will be utilizing telemedicine and computer based telemetry to minimize the burden of office visits on the individual and family.

NCT ID: NCT04017793 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Mindfulness-Associated Brain Changes in Adults With Autism

Start date: May 6, 2019
Phase: N/A
Study type: Interventional

The purpose of this study to measure brain functioning before and after stress-reduction classes to better understand how symptom improvements relate to brain functioning in adults with ASD (Autism Spectrum Disorder). Participants will be randomly assigned to one of two stress reduction classes that will meet once a week for 8 weeks. One group will complete a structured training program called Mindfulness Based Stress Reduction (MBSR) that involves teaching about increased mindfulness strategies and gentle stretching. The other group will review relaxation techniques and other stress reduction strategies and will include social support. Structural and functional MRI, EEG, and behavioral self-report data will be collected to understand more about how the brain changes in subtle ways when people feel better and are more aware of their emotional state.

NCT ID: NCT03984487 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder

Start date: May 17, 2018
Phase: N/A
Study type: Interventional

The main objective of the current proposal is to conduct a pilot RCT (i.e., treatment group and social skills control group) to examine how participation in Surviving and Thriving in the Real World (STRW) Intervention affects proximal outcomes with a larger sample size (n = 72). As social skills, executive functioning, and parenting factors have been linked to the acquisition of Daily Living Skills (DLS), the current study will also explore how these are linked to participation in STRW. Lastly, goal attainment scaling (GAS) will be utilized, along with gold standard parent report and adolescent self-report measures, to assess DLS.