Autism Spectrum Disorder Clinical Trials

The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants.. The main questions it aims to answer are: Identify voice factors among infants with newborn-detectable risk. Identify association between individual characteristics (Gestational age at birth, global function, motor-function) and voice factors. Examine unique features of voice production that are present in infants with high-risk for Cerebral Palsy (CP). Participants will be asked to upload a 3-minute videos of their child at term-age, 3.5-, and 9-months of age. At the 3.5-month and 9-month time point parents can choose to attend an optional in-person assessment with their child. Read Less

This pilot study aims to identify behavioral and neural measures of sensory processing and attention associated with routine occupational therapy intervention for children with autism spectrum disorders. Specifically, the investigator will examine the impact of a child's level of engagement during therapy using standardized behavioral and electroencephalography (EEG) measures of sensory processing. Read Less

Background: Findings from a group level assessment with caregivers of Black children with autism revealed barriers to equitable care and services (e.g., a lack of cultural representation among their child's care team, caregiver stress, stigma, and uncertainty about services needed). The Autism Doula program was identified by the community to address the aforementioned barriers and provide culturally matched family navigation and social-emotional support while also acknowledging the unique experiences and values of caregivers of Black children with autism. Impact: The current project aims to assess the acceptability, feasibility, and preliminary effectiveness of the Autism Doula program and promote equitable care for Black children with autism and their families. Methods: Fifty-six Black families of children 18 months to five years of age who recently received a new diagnosis of autism spectrum disorder from CCHMC will be recruited to the current study. Twenty-six families will be randomly assigned to either the control group (i.e., care as usual including DDBP Family Navigation) or the intervention group (i.e., Autism Doula services). Feasibility and acceptability data will be gathered, including satisfaction of both groups, how many families approached agree to be in the study, how many sessions with the doula were successfully completed, and was the intervention content delivered as intended. Additionally, preliminary effectiveness will be evaluated by examining completion of recommended next steps, caregivers' perceived stress, and self-efficacy. Implications: Data from this project will provide evidence that the Autism Doula program is feasible, acceptable, and effective, ultimately demonstrating it as an equitable care approach for Black children with autism and their families. Future Directions: Findings from this pilot project will highlight the need for growth of the Autism Doula program to promote culturally competent care and health equity for Black children with autism and their families. Read Less

The goal of this study is to identify which brain regions are active during speech-in-noise perception, as well as how those regions interact. The investigators are studying brain activation during speech-in-noise in autism and controls as well as individuals with Fragile X Syndrome. The main question\[s\] it aims to answer are: 1) How does the brain's response to background noise affect a person's ability to understand speech? 2) Can visual cues improve hearing in background noise? Participants will complete the following: * hearing tests * cognitive and behavioral measures * questionnaires about their symptoms * both passive and active hearing tasks while brain activity is recorded with a neuroimaging cap Results will be compared between individuals with autism with and without Fragile X Syndrome as well as individuals without autism. Read Less

The goal of this study is to test how well two group interventions work for middle-school children with Autism Spectrum Disorder (ASD). One of the interventions focuses on teaching parents and adolescent skills to help improve their social functioning and the other focuses on teaching parents and adolescents skills to improve organization, planning, and study skills. Eligible participants will be randomly (like a coin flip) assigned to attend one of the two interventions. Read Less

Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD) Read Less

Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have been made. Research has shown that individuals with FXS process sounds differently than those in the typical population, and they also show baseline differences in brain activity, including high gamma activity, increased theta activity, and decreased alpha activity. The investigators' central hypothesis is that these alterations in brain activity (specifically alpha and gamma activity) impair the brain's ability to process new information, thereby impeding cognitive functioning and increasing sensory sensitivity. The investigators propose that auditory entrainment, a technique that involves playing special sounds through headphones, will normalize brain activity in individuals with FXS and lead to increased cognitive function and decreased sensory hypersensitivity. Read Less

The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard. Aim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard. Exploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning. Read Less

Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation. Read Less

The purpose of this clinical trial is to investigate the effects of multiple sessions of transcranial direct current stimulation (tDCS) delivered while participants complete tasks that target social learning with high functioning adults with ASD and/or high traits of ASD. The main question it aims to answer is: What are the effects of multiple sessions of active compared to sham tDCS, with tDCS simultaneously paired with social learning tasks, from employing a within-subject, cross-over randomized controlled trial design? Participants will: * Complete a randomly assigned block of 5 sessions of active and a block of 5 sessions of sham tDCS, with a four-week break occurring between the two blocks. * Complete social learning tasks simultaneously during receipt of tDCS at each session (whether receiving active or sham tDCS). * Complete behavioral, physiological, and electrophysiological testing before and after each block of active or sham tDCS. * Complete a social validity questionnaire after completion of the study. Read Less

ADNP, also known as Activity Dependent Neuroprotective Protein, is a rare neurodevelopmental disorder caused by mutations encompassing the ADNP gene on chromosome 20. Clinically, ADNP syndrome is characterized by intellectual disability and global developmental delay. This study seeks to characterize ADNP-related neurodevelopmental disorders using a number of genetic, medical and neuropsychological measures. Read Less

Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot. Read Less