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Autism clinical trials

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NCT ID: NCT06058104 Enrolling by invitation - Clinical trials for Autism Spectrum Disorder

Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism

Start date: September 21, 2023
Phase: N/A
Study type: Interventional

The following study aims to assess the efficacy of the game-based digital therapeutic, GuessWhat, in improving adaptive socialization skills in children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen.

NCT ID: NCT05565482 Enrolling by invitation - Clinical trials for Autism Spectrum Disorder

Work Chat: An Interactive Virtual Workday

Start date: October 13, 2022
Phase: N/A
Study type: Interventional

Nearly 50,000 youth with autism spectrum disorder (ASD) transition from high school to adult life each year with only 25% of these transition-age youth with ASD (TAY-ASD) getting jobs within 2 years of graduation. TAY-ASD's ability to sustain employment is even more challenging due in part to their social cognitive deficits (e.g., poorly reading social cues) that disrupt communicating with customers, coworkers, and supervisors. Research shows nearly 90% of job dismissals among TAY-ASD are attributed to poor work-based social functioning (e.g., poorly communicating with upset customers). The subsequent unemployment has damaging effects on their mental, physical, and economic health. A critical gap in federally-mandated services to support youth with ASD as they transition from school-to-adult life is the lack of evidence-based practice to enhance work-based social functioning. Given that TAY-ASD report computerized training tools (developed by the investigators and others) are highly acceptable and improve their real-world outcomes, the investigators propose to address this critical barrier to sustained employment by developing and evaluating a novel and scalable computerized training tool to enhance participant conversations with customers, coworkers and supervisors at work. The investigators propose to develop and test the effectiveness of Social Cognitive and Affective Learning for Work (Work Chat: An Interactive Virtual Workday), a computerized training tool. Work Chat will have three tiers of instruction designed to help TAY-ASD prepare for effective workplace communication. Tier 1 will adapt existing evidence-based practices to design an e-learning curriculum that trains social cognitive strategies to help guide work-related conversations (e.g., reading social cues or regulating emotions during supervisor feedback). In Tier 2, SIMmersion's PeopleSim® technology will enable TAY-ASD to apply social cognitive strategies learned in Tier 1 to repetitively practice simulated conversations with a fictional customer, coworker, or supervisor. In Tier 3, SIMmersion will innovate PeopleSim to exist in an interactive 3-D environment to create a virtual workday with interconnected activities were the actions made early in the day influence conversations later in the day (e.g., a poor customer interaction may result in constructive feedback from a supervisor). Phase I (Feasibility) was completed with application HUM00177878. Phase II (Efficacy) Aims: Aim 1) Complete Work Chat development using an iterative process that includes initial and ongoing individual-level feedback from Phase I participants and the community and scientific advisory boards to complete the product that will be evaluated in Aims 2-3. Aim 2) Conduct a Randomized Controlled Effectiveness-Implementation hybrid trial in a school setting to evaluate Work Chat. The investigators will recruit and randomly assign n=338 TAY-ASD (90% of sample frame) enrolled in school-based standard transition services (STS) to the Work Chat group (STS+SW) or a STS group (STS). The hypothesis is that STS+SW, compared to STS, will show greater gains in: (H1) social cognition and (H2) work-based social functioning; as well as (H3) reduced anxiety about work-based social encounters, and (H4) greater sustained employment by 9-month follow-up. The investigators will test mechanistic hypotheses (H5a-b) that social cognitive ability (H5a) and work-based social functioning (H5b) mediate the effect of treatment (STS+SW vs. STS) on sustained employment. For the implementation evaluation, the investigators will conduct a multilevel, mixed-method process evaluation of Work Chat's acceptability, appropriateness, and feasibility. Aim 3) Use community participatory research methods to prepare for commercialization. The investigators will conduct a parallel multilevel, mixed method implementation evaluation that focuses on the Work Chat delivery system regarding its feasibility, sustainability, scalability, and generalizability by conduct focus groups with delivery staff and administrators. These groups will discuss potential facilitators and barriers to Work Chat implementation, adoption, and sustainability.

NCT ID: NCT05192993 Enrolling by invitation - Autism Clinical Trials

Effect of Oculomotor Exercise on Writing Capabilities on Autism

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Autism spectrum disorders (ASD)are neurodevelopmental disorders that are clinically characterized by a triad of features: impairments in social interaction, impairments in communication, and presence of restrictive repetitive and stereotypical behaviors, interests, or activities (DSM-IV). In addition to these core deficits, ASD is associated with a high prevalence of fine motor difficulties and executive function impairments that contribute to acquisition and performance of skilled motor tasks. It is therefore not surprising that handwriting difficulties are frequently reported in children with ASD.

NCT ID: NCT04909710 Enrolling by invitation - Clinical trials for Autism Spectrum Disorder

Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

The investigators will test the feasibility and preliminary efficacy of a Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. Investigators will enroll children with autism aged 2-8 years old and their neurotypical sibling or an unrelated neurotypical control (aged 2-8 years old).

NCT ID: NCT04859998 Enrolling by invitation - Clinical trials for Autism Spectrum Disorder

Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism

Start date: April 26, 2021
Phase: N/A
Study type: Interventional

The aim is to evaluate the effects of a dog-assisted therapy program on physical function and communication in a sample comprised of 24 adults with autism spectrum disorder. The sample will be divided into 2 groups, a control group and an experimental group. Changes after 10 weeks (20 sessions) will be compared between-groups.

NCT ID: NCT04805957 Enrolling by invitation - Clinical trials for Autism Spectrum Disorder

Validation Digital Bio-markers During Sulforaphane Treatment.

Start date: July 7, 2022
Phase: N/A
Study type: Interventional

The purpose of the research is to determine if changes seen during sulforaphane treatment (a compound that comes from eating certain vegetables) can better be understood using digital biomarkers. These digital biomarkers are things like heart rate, muscle movement etc. and are measured using non-invasive devices (like a watch) and are aimed at complementing the traditional clinical scores already in use in current trials (e.g. Aberrant Behavior Checklist (ABC), Social Responsiveness Scale (SRS) and Ohio Autism Clinical Impressions Scale (OACIS)).

NCT ID: NCT03724136 Enrolling by invitation - Alzheimer Disease Clinical Trials

Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study

ACIST
Start date: October 24, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the use of autologous Bone Marrow Derived Stem Cells (BMSC) as a means to improve cognitive impairment as occurs in Alzheimer's Disease and other dementias and to improve behavior and socialization issues which occur in adult Autism Spectrum Disorder. The use of Near Infrared Light, in conjunction with the use of BMSC, will also be assessed.

NCT ID: NCT03005431 Enrolling by invitation - Autism Clinical Trials

Parents of Newly Diagnosed Preschool Children With Autism Spectrum Disorder:

Start date: January 2017
Phase: N/A
Study type: Interventional

Manitoba parents of preschool children newly diagnosed with Autism must wait up to a year to receive government funded services for their child. During this delay parents need support and training to promote their child's development. The purpose of this research is to develop and evaluate an on-line, parent training and support program that will assist parents during this time. It is predicted that if parents receive on-line training and support they will increase their parenting knowledge and skills, reduce their stress, and create better outcomes for their child, in comparison to parents who do not receive the training. The experimental study (n=60) will use a randomized, masked, waitlist control design that compares a treatment group to a control group. Descriptive statistics will be used to describe differences between groups, ANCOVA's to test for differences between groups, and Pearson correlations to describe the relationship between parent stress and outcomes.

NCT ID: NCT02914951 Enrolling by invitation - Autism Clinical Trials

Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability

Start date: October 2016
Phase: N/A
Study type: Interventional

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. The purpose of this study is to investigate cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum disorders and intellectual disability. This pilot study will include children with ASD and IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity of activities during therapy sessions but retains all key elements and principles of CBT. Assessments of irritability and disruptive behavior will include clinical interviews, parent ratings and child self-report measures. Study participants will be asked to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and emotion regulation before and after CBT.

NCT ID: NCT01980186 Enrolling by invitation - Autism Clinical Trials

Transcranial Ultrasonography Using Linear 2D Imaging of the Brain

Start date: November 2013
Phase: N/A
Study type: Observational

This study will use linear 2D ultrasound imaging to look at the brain of individuals diagnosed with autism and their siblings. This is called transcranial ultrasound (TUS). It is hypothesized that TUS will allow real-time imaging of the fluid spaces outside the brain and will further allow the imagining of brain areas important to language and social function.