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Autism Spectrum Disorder clinical trials

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NCT ID: NCT05504863 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study

RAPIDIRON-KIDS
Start date: October 11, 2022
Phase:
Study type: Observational

As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. The study's overarching goal is to determine if the offspring born to RAPIDIRON Trial mothers in the intravenous iron groups, compared to the oral iron group, will achieve superior neurodevelopment, iron stores, and growth at specific time points during the first three years of life. Differences will be assessed between offspring based on the iron deficiency anemia (IDA) treatment of the mother.

NCT ID: NCT05499910 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Neuro Strengths-Based Approach to Autism

NSBAA
Start date: October 4, 2022
Phase: N/A
Study type: Interventional

The Neuro-Strength-Based Approach to Autism (NSBAA) attempts to translate what research has discovered about the autistic brain into terms that autistics, and those involved with autistics, can understand. It is not intended to be a new approach to intervention but hopefully a unifying approach to understanding autism that all therapists, educators, clinicians, and parents can use when working with autistic individuals. It was developed by an autistic occupational therapist, based on her lifetime obsession of learning everything she could about how typical brains work, and, following her diagnosis, how the autistic brain works. Being on the autism spectrum herself and having worked with, and interacted with, autistic individuals of all ages and abilities in school, clinical, and personal settings, the author attempts to explain the autistic brain from both the scientific as well as autistic perspectives.

NCT ID: NCT05450536 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Self-Advocacy Training for Autistic College Students at a Public University

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

Cases in autism spectrum disorder (ASD) have dramatically risen over the past 30 years, with the current rate of 1 in every 44 (Maenner et al., 2021) children born with the condition. Much emphasis rests on the need for various interventions, practices, and therapies during childhood to improve quality of life and success across a variety of settings. Nonetheless, as they age, all children advance through the education system and eventually leave the school system. Consequently, it should not be surprising that these children must grow up and face realities after high school. For some, this may include residential placements, living at home with family members, or working part or full time. For others, this comes in the form of postsecondary education. However, many individuals with autism might not be prepared to handle the requirements future education entails. As stated in articles by Chiang et al. (2012) and Blackorby and Wagner (1996), persons with disabilities, regardless of type, do not have successful transitions after high school compared to individuals without disabilities-even with having access to many resources in school and the community. Barriers, therefore, exist that prevent successful outcomes for students with autism attending college and obtaining a postsecondary degree. Thus, there is a need to identify strategies that can be effective in assisting autistic adults in postsecondary education to succeed, both academically and socially.

NCT ID: NCT05439954 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Radiomics of Autism Spectrum Disorder

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Autism Spectrum Disorder (ASD) refers to a group of neurodevelopmental disorders including autism.Despite ongoing studies, the pathogenesis of ASD still remains unclear.The global prevalence of ASD was estimated at 1% in 2015.The diagnostic criteria for ASD are specified in the DSM ( American Psychiatric Association, 2013 ) and serve as guideline for clinicians at the present. However, its early diagnosis value is limited due to a high subjectivities and its low diagnostic sensitivity and specificity.Early detection and early pharmacological and behavioral interventions are critical in improving the symptoms and preventing the disease progression. There are no medications that directly treat the core symptoms present in individuals with ASD, and the effectiveness of interventions remains limited. Therefore, accurate assessment of pharmacological efficacy is necessary for the reatment, and prognostication of individuals with ASD. Magnetic resonance imaging (MRI) is a commonly used imaging tool for clinical disease diagnosis, especially for neurological disorders. Besides, Structural Magnetic Resonance imaging reflects neuropathological and microstructural developmental changes during growth. Radiomics based on the high-dimensional quantitation of medical images, allowing extraction of more detailed characteristics than is possible with conventional visual interpretation. This study aims: (1)To explore an objective diagnostic method through radiomics in children with ASD (2)to provide prognostic estimates of the outcome, based on estimates of an individual patient's prognosis and the efficacy of different drug therapies.

NCT ID: NCT05212493 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

Start date: November 14, 2019
Phase: Phase 3
Study type: Interventional

Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Data on the effects of cannabidiol rich cannabis extract use for ASD is promising but still limited. The aim of this study is to investigate if oral cannabinoids treatment to children and young adults with ASD affect the comorbidities of autism, including sleep and eating problems, anxiety and violence. The main objectives of the study are: 1) to characterize the effect of treatment with cannabis oil on comorbid symptoms of ASD; 2) to compare safety and efficacy of different cannabis products with identical CBD:THC ratio; 3) to investigate the effect of treatment on cognitive and adaptive behavior; and 4) to measure THC and CBD and metabolites levels in the blood of the patients. In this study, patients diagnosed with ASD will be treated with cannabidiol-rich cannabis oil (CBD:THC ratio of 20:1). The researchers will collect parental reports on ASD comorbid symptoms before and bi-weekly during 6 months of the study period. Blood tests will be performed before and after three months of treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and metabolites. Cognitive evaluation will be done before and after six months of treatment. Electroencephalogram (EEG) to exclude epilepsy will be performed before and after six months of treatment.

NCT ID: NCT05194345 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD

Start date: January 27, 2022
Phase: N/A
Study type: Interventional

There is an unmet need for nutrition interventions that address both autism spectrum disorder (ASD) specific feeding challenges and unbalanced eating habits among children with ASD to prevent future chronic health conditions. Children with ASD tend to consume few fruit and vegetables and mainly high-energy dense foods, including sugar-sweetened beverages and processed snacks. Obesity prevalence in children with ASD is up to 40% higher than in typically developing children, and recent studies show significantly elevated risks of hyperlipidemia and hypertension among individuals with ASD, regardless of using psychotropic medications. Our interdisciplinary team conducted a preliminary study to examine diet quality and mealtime behaviors among diverse children with ASD in Florida (34% Hispanic/Latino) and parental preferences for nutrition interventions. Based on the study findings, we developed the manual for our nutrition intervention, Autism Eats, for children with ASD enrolled in the Part C of Individuals with Disabilities Education Act (IDEA) Early Intervention (EI) services. Our Autism Eats manual and parent materials are based on ASD-specific feeding strategies such as food chaining combined with behaviorally-focused nutrition intervention strategies such as goal setting and weekly meal planning to promote healthy eating. Among children with ASD enrolled in Part C EI services in Florida, we will conduct a randomized controlled trial (RCT) with the nutrition intervention program, Autism Eats, and the enhanced usual care (EUC) comparison program. The Autism Eats intervention is to prevent problematic mealtime behaviors and promote development of healthy eating habits. We expect that implementing the Autism Eats will be feasible and the intervention will be well-received by EI providers and parent-child dyads. We will examine differences in children's food intakes (fruit and vegetables), food variety, diet quality, and problematic mealtime behaviors between children in Autism Eats and those in the EUC groups at post-intervention and 5-month follow-up from baseline.

NCT ID: NCT05193500 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Study 3 Learning Verbs and Pronouns

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

The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children). Specific Aim 3 (Experiment 3): Determine whether children with ASD can learn verbs and pronouns by overhearing. Most prior work on learning from overheard speech has focused on learning nouns that label objects. This experiment extends this work to study other kinds of words.

NCT ID: NCT05192109 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children). Specific Aim 2 (Experiment 2): Determine whether children with ASD can learn from addressed and overheard teaching via videoconferencing. The investigators will use a similar procedure to Study 1, except that both overheard and directed teaching will take place on video.

NCT ID: NCT05151601 Active, not recruiting - Anxiety Clinical Trials

Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism

Start date: May 17, 2022
Phase: N/A
Study type: Interventional

This research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder. The study will use a combination of human milk oligosaccharides (HMOs, prebiotics) and probiotics as an oral powder.This clinical trial will have two consecutive phases. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment.

NCT ID: NCT05131659 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

This project explores the association between learning and cognitive flexibility by testing whether a cognitive behavioral intervention designed to improve flexibility in ASD changes learning and associated neural activation using model-based functional magnetic resonance imaging (m-fMRI). The study proposes that variability in learning mechanisms is associated with behavioral flexibility and explains differences in adaptive and treatment outcomes. The study employs a longitudinal case-controlled design in 60 14-18 year old youth with ASD at 3 time-points 8 months apart, each including m-fMRI during learning and behavioral measurement of executive and adaptive function. Aim 1 tests the hypothesis that individual variation in learning biases and their neural correlates predicts behavioral flexibility and is stable over time. Aim 2 tests plasticity of learning mechanisms induced by a cognitive-behavioral intervention for flexibility. Aim 3 tests hypothesis about intervention-induced plasticity of neural functional connectivity.