View clinical trials related to Autism Spectrum Disorder.
Filter by:The overall objective of this study is to determine the effectiveness of the Floreo VR Joint Attention Module in improving social communication skills in children with ASD. An additional objective is ongoing investigation of the tolerability of the product and the extent of potential adverse effects of Floreo VR, if any.
This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared to healthy subjects with normal hepatic function matched by age (±10 years), sex, and body mass index (BMI; ±20%).
The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.
Adolescent autism spectrum disorder subjects with associated GI symptoms will be randomized to receive oral dosing of CP101 capsules in Treatment Group I or matching placebo capsules in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 in subjects with ASD and associated GI symptoms.
Background: Previous research has shown that individuals with ASD often have difficulties coping with auditory stimuli in the environment. These difficulties can be extremely debilitating, lead to anxiety and disruptive behaviors, and interfere with the ability to process and understand speech. Research Design: In previous research, the investigators have identified a brain marker associated with poor auditory attention that can provide a direct readout of auditory processing issues. The investigators will develop and test a cognitive/behavioral intervention (a tablet-based game app) that is highly engaging and accessible to a wide range of individuals with ASD. The intervention is designed to train adolescents with ASD to adapt and attend to auditory cues. Objectives: To evaluate whether the intervention leads to improvement in auditory attention as assessed by behavior changes over the course of training; to investigate the impact of the intervention on behavioral assessment of problems hearing speech in noisy environments, neural processing of sounds, and changes in parent report on responses to sounds that impact that daily lives of the participants; and finally- to determine which adolescents with ASD benefit the most and least from interventions such as this one. We hypothesize that we can elicit changes in the neural processing of sounds for adolescents with ASD via training in the form of the tablet-based game we are developing. If we are successful, this could lead to other interventions for persons with ASD in the hopes of improving the auditory difficulties they face.
This study evaluates the effects of essential oils on anxiety scores among children who have an autism spectrum disorder. One third of the children will receive a control blend of oils, one third of the children will receive a test blend of oils, and the other third will receive a second test blend of oils.
Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder (ASD) and is the source of considerable stress for the affected individual and family. Sleep plays a role in development and learning processes; thus, the appropriate treatment of sleep disturbance is paramount to optimal outcomes. The empirical base for treatments to address sleep in ASD is sparse, despite wide use of pharmacologic agents such as clonidine (CLN) to target sleep disturbance. A randomized, controlled pilot investigation of CLN for sleep disturbance in children with ASD will allow investigators to evaluate the feasibility of conducting a much larger multisite trial to address the general lack of systematic data available to guide practitioners. Subjects will be 16 children, ages 6-14 years, inclusive, with sleep disturbance and ASD. This randomized double-blind, placebo-controlled (PBO), parallel groups study will test the efficacy of CLN following a brief sleep hygiene intervention. Outcome measures include: informant completed sleep questionnaires, daytime behavior questionnaires, and actigraphy. Biomarkers for medication response will include galvanic skin response and skin temperature. Side effects will be monitored throughout the study.
Specific Aim 1: Obtain proof of concept evidence that cortical metrics will change in response to treatment with Memantine extended release (XR)®, an agent that modulates n-methyl d-asptartate (NMDA) receptor activation, in children with autism spectrum disorders (ASD) who clinically demonstrate treatment response. Hypothesis1: Children with ASD who have dramatic clinical response to Memantine XR® will exhibit changes in their cortical metrics, which will differ less from neurotypical children. Subjective ratings of improvement will be correlated with the change in cortical metrics. The completion of these aims will be essential to design a larger federally funded trial to validate cortical metrics as an outcome measure in a more heterogeneous pediatric ASD sample. Specifically, the feasibility data obtained may demonstrate the potential for detecting changes in cortical metrics over time, so that a larger grant could focus on determining how sensitive and clinically relevant changes in cortical metrics are or may indicate the need to explore different interventions to use in a validation study. We have chosen to use Memantine XR® because of its impact on NMDA neurotransmission, its current evaluation in a large multi-site randomized ASD clinical trial whose initial results are expected shortly, and our own observations of clinical improvements and good tolerability in the ongoing trial.
The investigators hypothesize that EPI-743 may provide clinical benefit to children with Autism Spectrum Disorder.
The investigators overarching aim is to obtain preliminary data to support a larger grant to validate a novel objective, physiologically-based outcome measure for clinical trials in autism spectrum disorders (ASDs) called the cortical metric. Absence of such an outcome measure has greatly hindered the development of treatments for core symptoms of ASD.