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281 active trials for Autism Spectrum Disorder

Examining the Active Ingredients of Consultation to Improve Implementation of a Parent-mediated Intervention for Children With Autism in the Community Mental Health System

Parent-mediated interventions are considered best practice for treating children with autism spectrum disorder, but these interventions are underutilized in community settings. Implementation strategies like consultation can improve the implementation of these interventions, but little is known about the active ingredients of consultation. This study uses an experimental design (ABCD single-case design with multiple baselines) to identify the active ingredients of a consultation model designed to support the implementation of a parent-mediated intervention for autism spectrum disorder in a low-resourced community mental health system.

Start: May 2021

Age-related Changes in Myeloarchitectonics Across Adulthood in Autism Spectrum Disorder

There is increasing awareness in the Autism Spectrum Disorder (ASD) research field about the deficit of knowledge with regard to the neurobiological, cognitive, and behavioral changes that occur in adults with ASD across the later portion of the lifespan. Decline in motor skills and cognitive function in typical aging can have devastating impacts on an individual's ability to organize and maintain activities of daily living. While there is an overall lack of research on how these processes unfold across aging specifically in ASD, previous research findings of motor and cognitive deficits in young adults with ASD, localization of these functions to the anterior cerebral cortices, and trajectories of decline in typical aging indicate that motor skills and executive function are particularly at risk in the disorder in later life. In vivo myeloarchitectonic mapping based on Magnetic Resonance Imaging (MRI) provides a unique view of gray matter structure and has the potential to elucidate abnormalities of local cortical connectivity. It has shown promise for the identification of biomarkers of disease pathogenesis in clinical studies, and it provides unique information beyond the cortical thickness measurements that have been employed in previous studies of ASD and typical aging. Myelin mapping may also be a more reliable index of neurobiological aging, given some questions about the accuracy of cortical thickness measurements. Given these properties, it may be a particularly informative measure in the context of potential accelerated decline in ASD. Intracortical myelin development and remodeling are protracted across the typical lifespan, with evidence of abnormal cortical myelination in other neuropsychiatric disorders, as well as in age-related mild cognitive impairment and dementia. In young adults with Autism Spectrum Disorder (ASD) myelin content is reduced in white matter and presumably in cortical gray matter as well. However, patterns of intracortical myelination have not yet been examined in ASD at any age leaving an important gap in the current knowledge base. With the added risk of demyelination associated with aging, older adults with ASD may be the most important population to examine as they may be doubly at risk of deficits in cortical myelination. Importantly, this could have knock-on effects on cognitive and motor functions in light of myelin's role in synaptic plasticity and maintenance of intracortical circuits. The proposed fellowship project aims to bridge this gap in knowledge by investigating the age-related trajectory of intracortical myelin in middle aged to older adults with ASD and clarifying the spatial distribution of any abnormalities. Known heterogeneity in the clinical presentation and neurobiological phenotype across the autism spectrum poses a significant challenge in this research field. The proposed project includes innovative statistical approaches to help parse this heterogeneity. Intracortical myelin will be analyzed cross-sectionally using both group-wise and subject-specific approaches and with any findings confirmed with follow-up longitudinal data. This multifaceted approach will allow for a comprehensive characterization of myeloarchitectonics in adults with ASD, and also holds the potential to elucidate important links between brain structure and behavior in the disorder. Specific Aims Aim 1: Determine if intracortical myelin content and rates of age-related change differ between individuals with ASD and age-matched control participants aged 40-65 years. Hypothesis 1: Group-wise analysis will reveal decreased intracortical myelin content in ASD in association cortices of the frontal and parietal lobes. Hypothesis 2: Subject-specific analyses may reveal spatial variability across individuals in the precise brain regions demonstrating abnormalities of intracortical myelination, but with frontal and parietal regions more frequently or more heavily affected. Hypothesis 3: Both cross-sectional approaches will reveal a pattern of accelerated cortical demyelination with greater age in ASD. Aim 2: Relate local myelin content measures to cognitive and behavioral abilities that are at-risk of decline during aging, including motor skills and executive functions. Hypothesis 4: Age-related decline in domain-specific behavioral abilities will correlate with atypical patterns of intracortical myelination from Aim 1.

Start: May 2015

The Effects of Covid-19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder

The aim of the questionnaire and semi structured interview was to understand how the Covid 19 pandemic has impacted the cardiovascular health, physical activity levels, sedentary behavior, sleep, anxiety levels and eating habits of children with ASD in comparison to before the pandemic.

Start: October 2019

Open Label Phase I hCT-MSC in Toddlers With Autism Spectrum Disorder

This is a single site, prospective study of one intravenous infusion of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in toddlers with autism spectrum disorder (ASD). Toddlers 18 to 48 months of age with a confirmed diagnosis of ASD will be eligible to participate. Diagnosis will be confirmed at the time of the eligibility visit at the Duke Center for Autism and Brain Development. All participants will receive a single intravenous dose of 2x106/kg hCT-MSC per kilogram at baseline. Assessments will be conducted at baseline and 6 months, with remote follow-up assessments at 12 months.

Start: February 2021

hCT-MSC in Children With Autism Spectrum Disorder

The purpose of this Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication abilities in children with autism spectrum disorder (ASD).

Start: October 2020

Validation Digital Bio-markers During Sulforaphane Treatment.

The purpose of the research is to determine if changes seen during sulforaphane treatment (a compound that comes from eating certain vegetables) can better be understood using digital biomarkers. These digital biomarkers are things like heart rate, muscle movement etc. and are measured using non-invasive devices (like a watch) and are aimed at complementing the traditional clinical scores already in use in current trials (e.g. Aberrant Behavior Checklist (ABC), Social Responsiveness Scale (SRS) and Ohio Autism Clinical Impressions Scale (OACIS)).

Start: April 2021

Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder

The purpose of this study is to examine changes in adaptive functioning, quality of life, and prospective memory among adults with ASD (Autism Spectrum Disorder) who complete Strengthening Skills, a multi-faceted, behavioral intervention that combines the PEERS Social Skills program with cognitive compensation training, mindfulness-based emotional regulation, and support group components. Participants and their study partners (e.g., spouse, parent, friend) will be randomly assigned to one of three groups: Strengthening Skills, PEERS only, or a delayed treatment control group. The Strengthening Skills group will meet weekly for 3 hours for 16 weeks and will learn strategies for gaining and maintaining independence and emotion regulation. Participants will also learn strategies from the PEERS Social Skills Program. The PEERS only group will meet weekly for 1.5 hours for 16 weeks and will only learn strategies from the PEERS Social Skills Program. The delayed treatment control group will participant in data collection at four time points over a 10-month wait period, after which, they will be enrolled into the Strengthening Skills Program. Behavioral self-report data will be collected and a prospective memory assessment will be conducted before and after participation in the 16-week programs. Behavioral self-report data will also be collected at remote 3- and 6-month follow-up visits.

Start: April 2021

UCB Stem Cells for Autism Spectrum Disorders

Purpose. The goals of the study are to assess the safety of the intravenous infusion of umbilical cord blood (UCB) cells in patients with autism and to confirm changes in social/ communicative skills and cognitive functioning after four infusions of ABO/Rh-matched UCB stem cells. Material and methods. The sample comprises 30 patients (27 males, 3 females) aged between 3 and 11 years with ASD under the care of the National Medical Research Center for Psychiatry and Neurology (Saint-Petersburg, Russia). Participants are randomly assigned to either the control group (14 males, 1 female) or the experimental group (13 males, 2 females). The experimental group receives intravenous injections of UCB cells four times with a two-week gap between injections. The control group receives standard therapy. The dynamic of cognitive functions and social/communicative skills assess with Checklist for autism spectrum disorders (CASD), Autism treatment evaluation checklist (ATEC), subscales of Wechsler Intelligence Scale for Children (WISC) - "Digit Span", "Picture completion", "Block design", "Coding".

Start: November 2019

Propranolol for Challenging Behaviors in Autism

Severe challenging behaviors such as aggression and self-injury can cause significant morbidity and decrease the quality of life for individuals with Autism Spectrum Disorders (ASD). There are only two medications (Risperdal and Abilify) rigorously studied and FDA-approved for the treatment of irritability in individuals with ASD. These medications are not always successful and have many short and long-term side effects. Well-designed studies demonstrating efficacy and safety of alternative medication treatment choices are needed. There is preliminary evidence that high-dose propranolol can be effective in individuals with ASD who display severe aggression and have not responded to antipsychotics or mood stabilizers. Concerns regarding the safety of high dose propranolol have limited its clinical application. Well-designed clinical trials demonstrating the efficacy and safety of high dose propranolol will have significant effects on clinical practice and improve the physical and behavioral quality of life for an underserved subset of individuals with ASD. This study will pilot the safety and efficacy of high dose propranolol. The investigators will randomly assign participants to either propranolol or to placebo later crossing each participant over to the other group. As propranolol can cause changes in blood pressure and heart function, each participant will complete initial comprehensive testing to monitor cardiac safety throughout the study. The investigators will be utilizing telemedicine and computer based telemetry to minimize the burden of office visits on the individual and family.

Start: January 2021

Comparative Effectiveness of EIBI and Adaptive ABA for Children With Autism

Approximately 15,000 children with autism spectrum disorder (ASD) in military families currently receive applied behavior analysis (ABA) interventions through TRICARE insurance. This includes early intensive behavioral intervention (EIBI), which involves 20 or more hours per week of individualized instruction based on ABA and is often considered the standard of care for toddlers and preschoolers with ASD. More recently, research has found that less intensive, time limited ABA interventions can effectively target specific core and associated features of ASD. With these latest data, the investigators assert that an individualized approach to adapting and combining targeted interventions could be at least as effective as EIBI, yet substantially reduce expenditures of time and resources. The investigators call this approach adaptive, modular ABA (MABA), and propose to compare EIBI as usual, provided for approximately 20 hours per week, and MABA, provided for up to 10 hours per week, in a 24-week RCT of 132 children with ASD, under age 5 years, in military families. The investigators hypothesize that, at the end of intervention, MABA will be no less effective than EIBI as usual, or only slightly so, on the primary outcome measure (a standardized measure of adaptive skills). The primary investigators also hypothesize that, at follow-ups conducted 24 weeks after intervention and 90 weeks and/or when children are 5 years old, MABA will be superior to EIBI on primary and secondary child outcomes (tests of cognitive and language function, parent- and provider-rated ASD symptoms and adaptive skills) and on parent outcomes (parent stress and sense of competence).

Start: August 2019

Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder

The objective of this study is to evaluate the metabolic effects of a comprehensive wide-spectrum supplement for children with ASD to determine whether it physiologically targets mitochondrial pathways known to be abnormal in children with ASD.The intervention is a commonly used wide-spectrum nutritional supplement, which is theoretically designed to normalize mitochondrial function. The investigators aim to determine if the supplement does have the hypothesized effect on physiology in individuals with ASD. The investigator will enroll up to 50 children, aged 4 to 14 years of age with confirmed ASD and mitochondrial dysfunction, and participation will last 26 weeks.

Start: February 2020

SweetDreams Sleep Study for Children With Autism

This proposal will acquire preliminary data on the feasibility and effectiveness of an innovative and scalable strategy for improving access to effective sleep health care for preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop and test an on-line delivery adaptation of the existing behavioral sleep interventions for preschool aged children.

Start: September 2020

Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium

The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves language as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known language delays or impairments. Participation will last approximately 26 weeks from screening to end of treatment.

Start: September 2020

Robot-Mediated Intervention for Children With Autism Spectrum Disorders

This study is being done to examine the impact of an interactive, social robotics program in helping children with autism spectrum disorders (ASD) understand emotions and how to better recognize emotions while interacting with others. Eligible families will be randomized to either the robot intervention (n=20) or a no intervention (TAU; n=20) condition for 8-14 weeks. Assessments will occur at pre- and post-intervention as well as weekly for both conditions.

Start: November 2015

Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism

The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves social communication as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known social and communication delays. Participation will last approximately 26 weeks, from screening visit to end of treatment.

Start: October 2020

Evaluating a Social and Communication Intervention for Preschoolers

The purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (ASD). Through interactive development (continually seeking educator feedback for intervention improvement) and implementation of the intervention, the investigators hope to provide a feasible and practical means for educators to work with children with ASD in real world, large scale settings. ASD preschool educators, the children enrolled in their classes, between the ages of 3 and 6 years and their families may join.

Start: July 2012

Aquatic Therapy and Autism Spectrum Disorders

To compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (ASDs).

Start: June 2017

Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders

The purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. We will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.

Start: February 2021

Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges

The goal is to pilot a parent-mediated intervention for feeding challenges in children with autism building on recent research and current successful models already being used. A parent-mediated intervention would primarily occur in the home environment, working with the parent to establish goals and implement the intervention based on their child's specific needs.

Start: February 2017

Confirmatory Efficacy Trial of Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder

This study will investigate and confirm the efficacy of two psychological treatments for adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive remediation intervention that aims to help adults with problems in thinking, planning, and socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that aims to help adults learn about their condition, manage their emotions and stress, improve their social skills, and cope with everyday problems.

Start: June 2015