Active clinical trials for "Autism Spectrum Disorder"

Difficulties in reciprocal social interaction are hallmark features of several neuropsychiatric disorders, most notably autism spectrum disorder (ASD) and schizophrenia spectrum disorder (SSD). While recent studies have demonstrated substantial overlap in genetic etiology between ASD and SSD, little is known about common versus unique neural mechanisms that may underlie these downstream social deficits that cross diagnostic boundaries. Thus, a comprehensive imaging study examining social deficits in youth with ASD and adolescent- onset SSD at the neurochemical, connectivity, as well as functional activation level will be crucial in furthering our understanding of these underlying neural mechanisms. Specifically, the current project aims to examine how targeted social skills interventions may impact the organization of large-scale functional brain networks implicated in social cognition in these disorders, leading to improved outcomes. Thirty adolescents with ASD and 30 adolescents with SSD will undergo the Program for the Education and Enrichment of Relational Skills (PEERS), which is a 16-week parent-assisted social skills intervention that aims to improve friendship quality and social skills in teens with social difficulties. All participants will receive pre- and post-treatment MRI scans including functional MRI and magnetic resonance spectroscopy to quantify neural changes resulting from the intervention. All participants will also receive behavioral and social cognition assessments pre- and post-intervention to quantify real- world gains in social behaviors resulting from the intervention. Additionally, 30 typically developing adolescents will be recruited to serve as control participants and undergo two MRI and behavioral assessment sessions 16-weeks apart with no intervention in between. Specific aims include (1) examining inter-group disruptions in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions pre-treatment in ASD and SSD groups, (2) examining inter-group changes in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions in response to treatment in ASD and SSD groups, and, (3) dimensionally identifying intra-group differences in brain responses and how they relate to real-world treatment outcomes.

Limited psychological support for parents of children with special needs in Hong Kong can profoundly impact the child rehabilitation process and the well-being of parent-child dyads. Leveraging previous evidence from our team's research, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents. Pai.ACT incorporates the counselling logic of Acceptance and Commitment Therapy (ACT) through natural language processing, enabling parents to engage in human-like voice-to-text conversations and receive assessments and stepped-care mental health interventions, including guided self-help materials and real-time, individual-based counselling based on ACT. Following the research and development phases, we aim to kick off the utilisation of Pai.ACT by (1) pilot-testing its feasibility, acceptability, and potential efficacy in improving mental health outcomes for parents of children with special needs and (2) researching to determine the most optimal service model for parents by exploring their perceptions through focus group interviews. Pai.ACT offers accessible and comprehensive mental health services to all Chinese-speaking parents, addressing their psychological burden in caring for children with special needs. Pai.ACT could bring substantial and enduring societal benefits to Chinese-speaking families by integrating mental health support services for family caregivers with current child rehabilitation services and non-governmental organisations. Furthermore, this could contribute to reducing the public stigma attached to special needs children while increasing mental health awareness.

There is an urgent need for improved access to effective autism treatments. With advances in technology, distance learning models have particular promise for families who cannot access evidence-based parent training locally or may be on long wait-lists for behavioral treatments. Pivotal Response Treatment (PRT) is an established treatment for autism spectrum disorder (ASD); however, a telehealth PRT model has not yet been evaluated in a controlled trial. This study will examine the effects of training parents in PRT via secure video conferencing and investigate 1) whether parents can learn via telehealth to deliver PRT in the home setting (PRT-T) and 2) whether their children will show greater improvement in functional communication skills compared to children in a waitlist control group. Participants will include 40 children age 2 to 5 years with ASD and significant language delay. Eligible children will be randomly assigned to either PRT-T (N=20) or waiting list (N=20). Weekly 60-minute parent training sessions will be delivered for 12 weeks via secure video conferencing software by a PRT-trained study therapist. The effects of PRT-T on parent fidelity of PRT implementation, child communication deficits including frequency of functional verbal utterances, and parent-report of communication skills on standardized questionnaires will be evaluated. This research will provide a foundation for wider dissemination of technology-based solutions to improve access to ASD treatment.

This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted at the University of Texas Health Science Center at Houston and Memorial Hermann. Biomarker identification includes Integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology & Microbiology of Baylor College of Medicine.

In the proposed pilot study, ASD+ toddlers will undergo Social Value Training (SVT) using a gaze-contingent eye-tracking paradigm in toddlers with elevated symptoms of ASD (ASD+) (n=48). SVT will be administered over a two-day period and the training effects will be assessed by changes in visual attention to high-value (HV) faces as compared to low-value (LV) faces between baseline, post-baseline, and a follow-up assessment using two tasks: a laboratory selective attention (LSA) task and real-world selective attention (RWSA) task. The investigators will also evaluate acceptability and feasibility of the value training and contribution of sex, nonverbal developmental level, and severity of autism symptoms to response to the training.

This research study, Personalized, Responsive Intervention Sequences for Minimally Verbal Children with Autism (PRISM), is designed to maximize language outcomes for limited-language preschoolers, thereby lowering the risk of being classified as "minimally verbal" at age 6, by empirically developing a two-stage, 20-week adaptive intervention approach in a real world community settings. If found efficacious, the adaptive intervention design will capitalize on the heterogeneity and evolving status of children with ASD by providing the best intervention (DTT, JASPER and CET) for children who need it (leading to individualized sequences of intervention), only when it is needed (potentially reducing burden on children).

This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.

This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum disorder (ASD) and current symptoms of emotional dysregulation.

The number of students aged 6-21 years with an educational classification of autism spectrum disorder (ASD) in the United States grew by about 19 times over a 19-year period-from 29,076 in 1995-6 to 545,198 in 2014-2015 (IDEA Data Center, 2018). Meeting the needs of this growing population of students is a significant concern for schools (Bowen, 2014). Investigators have described as many as 27 efficacious intervention strategies for teaching new skills to children with ASD (Wong et al., 2015). However, these strategies are only rarely implemented in schools. In a survey of 185 teachers across the state of Georgia working with at least one student with ASD, fewer than 5% reported using an evidence-based intervention (Hess, Morrier, Heflin, & Ivey, 2008). To address gaps in current practice for students with ASD, there is a need for (1) a process for selecting and implementing interventions that can address the multi-faceted needs of students with ASD and (2) a service-delivery system that is feasible, flexible, durable, effective, and sustainable in schools. The investigators hypothesize that The Modular Approach for Autism Programs in Schools (MAAPS), an individualized, comprehensive modular intervention system, will address this gap. MAAPS integrates evidence-based strategies to address core and associated features of autism spectrum disorders (ASD) to enhance the success of elementary students with ASD in schools. The primary aim is to evaluate whether, compared to services as usual, MAAPS improves teacher outcomes and subsequent student educational outcomes.

Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all U.S. States. This project will train EI providers to use an evidence-based, inexpensive, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.