Autism Spectrum Disorder Clinical Trials

The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures. Read Less

Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD. Read Less

The purpose of the proposed three-site study is to test whether an educator-level implementation strategy, coaching, with or without a school-level implementation strategy, school-based teams, will maximize paraeducators' use (fidelity and sustainment) of an evidence-based social engagement intervention, Remaking Recess (RR). RR aims to improve peer related social skills for autistic students and their non-autistic peers who are socially isolated or peripheral and need support during recess. Read Less

Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Deficits in executive functioning are likely to be involved in many of these cognitive and learning disabilities due to poor functioning of the prefrontal cortex. Currently, the use of biological methods for improving learning and cognition is largely unexplored in research and practice. The aim of this study is to use of transcranial direct current stimulation (tDCS) in combination with ABA to improve the acquisition of educational programs for students with ASD. tDCS is a low-level electrical neurostimulation and is most effective when used in combination with an active training or teaching, facilitating the neuronal circuits used for that task. tDCS has been used for various indications over a couple of decades and has been shown to be very safe and has been well-tolerated by children with ASD. The mechanism of tDCS is not clear, however animal studies show that tDCS can stimulate the flow of calcium ions through channels in the astrocytes, activating them, and facilitating their role in synapse formation and therefore learning. Read Less

The goal of this randomized clinical trial is to compare and learn about Virtual Reality (VR) in children with autism/Autistic children. The main question it aims to answer is: • Does the Floreo VR clinical product show clinical improvement in autism symptoms? Participants will engage the VR product for twice a week for twelve weeks. They will be randomized to either the Floreo Clinical Product or a VR Control group experience. Researchers will compare the two groups to see if there is an effect on learning specific skills and behaviors. Read Less

The goal of this clinical trial is to learn if propranolol can help reduce challenging behaviors associated with Autism Spectrum Disorder, including aggression, self-injury, and severe disruptive behaviors. Participants will be randomly assigned to receive either propranolol or a placebo (a look-alike substance that contains no drug) daily for 12 weeks. After the 12 weeks, all participants will have the opportunity to receive propranolol for an additional 12 weeks. Read Less

This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders. This trial, done in the context of routine clinical care, will seek to evaluate whether aripiprazole or risperidone is associated with more weight gain in children. Read Less

Background: Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role. Objective: To learn about genetic \& brain features that explain why levels of impulsivity and compulsivity vary across people. Eligibility: People ages 6 - 80 Design: Participants will be screened with a medical history and medical record review. Participants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys. Participants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken. Participants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game. Participants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study. Participants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month. Read Less

Children on the autism spectrum sometimes have difficulty learning new words and using the newly taught information in different situations. In this study, the investigators are testing whether strategies that have been found to improve word learning in non-autistic children will also help autistic children. Specifically, the investigators aim to test whether autistic children learn words more successfully if novel words are taught by repeating the words to the child (re-study) or if the novel words are taught first with labeling each word and then quizzing the child (repeated quizzing). The main questions it aims to answer are: * When teaching nouns (names of exotic animals), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught words? * When teaching adjectives (visible features of objects, like a bumpy chair), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught adjectives? * Does the word learning condition (re-study vs. repeated quizzing) impact whether autistic children are more successful in demonstrating their knowledge of the newly taught words in different contexts? * Are autistic features related to patterns of word learning? Participants will: * Learn new words with half of the words being taught in one way (re-study) and the other half of the words being taught in the other way (repeated quizzing). * Participate in 5-minute and 1-week tests of the newly taught words to measure child learning. * Complete other language, thinking, and autism clinical assessments. Read Less

This Phase 2 study examines the safety, tolerability, and preliminary efficacy of pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged 16 to 40 years of age will be randomized to receive single doses of either placebo or pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by open label extension. Read Less

This is a randomized interventional study designed to evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in adults with autism spectrum disorder (ASD). Read Less

The goals of this project are to (a) incorporate empirical findings on imitation training and learning in autistic children into a comprehensive protocol for Applied Behavior Analysis practitioners designed to rapidly facilitate generalized imitation called Emergent Multi-Class Imitation Training (EMIT), and (b) collect pilot data on the efficacy of EMIT with a small sample of autistic children. EMIT will incorporate several features that are grounded in prior research including: (a) evidence-based procedures for establishing trained matching relations (a pre-requisite to generalized imitation), (b) concurrent training of different response types (e.g., motor imitation, object imitation, vocal imitation) to address restricted generalization, (c) multiple manipulative object imitation training, (d) evidence-based procedures for remediating slow acquisition, and (e) frequent tests for the emergence of generalized imitation. EMIT will be the first protocol designed for clinical use that reflects research findings on imitation learning spanning almost five decades. Read Less