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281 active trials for Autism Spectrum Disorder

KF STRIDE to Improve Job Interview Skills

The goals of the current study are to evaluate the preliminary effectiveness and feasibility of Kessler Foundation-Strength Identification and Expression (KF-STRIDE) in an 8-week randomized controlled trial comparing the intervention to services as usual (SAU).

Start: March 2021

Autism Biomarker Consortium for Clinical Trials (ABC-CT): Follow-up Study

This is a multicenter longitudinal follow-up study to the main study of an a registered already (NCT# ). The Follow-up Study (T4) will assess the Main Study cohort for an additional longitudinal time point approximately 2-5 years after the initial study. Children participating in the Follow-up Study will be approximately 8-16 years old. The aims of the main study is to identify, develop and validate a set of measures that can be used as stratification biomarkers and/or sensitive and reliable objective measures of social impairment in autism spectrum disorders (ASD) that could serve as markers of long term clinical outcome.

Start: April 2021

Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder

This study will evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in Autism Spectrum Disorder (ASD). Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and an EEG (electroencephalogram) and eye-tracking session to measure neural and visual attentional social response before and after administration of TMS.

Start: July 2019

Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

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

Start: January 2021

Using Serious Games to Improve Social Skills in Autism

The investigators will conduct a small-scale randomized control trial comparing the intervention game to an active control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). These outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to uncontrolled, real-world social interactions between dyads.

Start: December 2019

Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD

A feasibility controlled trial of an eight-session group intervention for siblings of children who have an Autism Spectrum Disorder (ASD). Children will be recruited from a multi-academy trust of nine schools. Due to the on-going impact of COVID-19 restrictions, children will be allocated to the intervention condition (eight session support group) if they are physically attending school and to the control condition (receipt of a booklet) if they remain at home. Pre and post outcome measures will be completed by children and their parents in both research arms.

Start: December 2020

Effectiveness of a Short Computer-based Emotion Recognition Training in Different Patient Groups

Emotion recognition and regulation are necessary skills for social interaction. Disrupted development of these processes severely interferes with socio-emotional development. These difficulties are commonly reported in patients with Autistic Spectrum Disorder (ASD) or Conduct Disorder (CD), with the subsequent social/interpersonal difficulties. The available evidence suggest that impaired emotion regulation processes might underlie the aggressive behaviours frequently observed in both disorders. However, no study has yet investigated the presence of disorder-specific characteristics on emotion processing between these two disorders. Different impaired emotion recognition difficulties may underlie the reported emotion dysregulation. A practical implication of this is that given that both disorders have shown difficulties during emotion recognition processes, a short, computer-based intervention to improve emotion recognition might benefit both cases, even though their aetiologies might differ.

Start: April 2021

Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China

Objectives The primary objective of this study is to evaluate the effectiveness of the SREIA parent training program for families of children with ASD aged three to six years in mainland China. The study will be conducted within the context of routine service provision and assess the effectiveness of SREIA in reducing child behavioral problems as measured by the Externalizing scale of the Child Behavior Checklist (CBCL) for Ages 1.5-5, in comparison to a waitlist control group. Secondary objectives include examining the effectiveness of the SREIA program in reducing ASD symptoms and improving parental and familial outcomes including parental knowledge of ASD and ABA techniques, parenting styles, parental mental health (including stress, anxiety and depression), and family functioning. A process evaluation will be conducted alongside the quasi-experimental trial, the objectives of which are to 1) describe the implementation aspects of the programs with regard to participant involvement, program acceptability, delivery, and sustainability; 2) explore predictors of participant involvement; and 3) examine potential relations between implementation aspects and treatment effects. Background ASD is associated with elevated levels of child emotional and behavior disturbance, which impair child daily functioning and impose challenges to parenting. The SREIA programme is a group-based parent training in China, that has been delivered since 1993 and reached over 10,000 families. However, there is an absence of scientific evaluations of programme effectiveness. This study aims to fill this evidence gap, and the findings will be used to inform future modification, replication, and dissemination of the programme in other parts of China. This study will also contribute to the literature on the effectiveness of parent training programmes for ASD and for families living in low- and middle-income countries. Methods A quasi-experimental design with a mixed-methods approach will be used, involving two consecutive waves of delivery of the SREIA programme. Parent participants will complete demographic and outcome questionnaires at baseline, immediate post-intervention, and 6-month post-intervention (conditional to funding). The implementation components will be assessed by collecting attendance and engagement registry data, facilitators filling out fidelity checklists, research staff observing programme sessions, and parents answering a satisfaction questionnaire. After the programme, some parents, facilitators, and NGO (non-governmental organisation) managers will be invited to take part in qualitative interviews or focus group discussions so as to explore their views about the programme, and to better understand the quantitative data obtained.

Start: September 2020

Telehealth Intervention for Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children. Most children with ASD experience challenges participating in daily activities (e.g.: eating, sleeping, bathing, grooming, playing, etc.) and receive occupational therapy intervention to address these. The COVID-19 pandemic has restricted in-person therapy for many of these children and there is an urgent need for evidence-based, validated telehealth intervention. This project will adapt an evidence-based occupational therapy intervention, termed OT4ASD to a telehealth delivery model. The aims of the project are to: 1) adapt the existing intervention protocol to a telehealth delivery model, 2) train therapists and evaluate the therapist's ability to conduct OT4ASD, 3) determine if OT4ASD delivered via the telehealth is acceptable and feasible to parents and interventionists; and 4) whether children improve in the daily living skills. OT4ASD follows a systematic protocol and uses active, individually-tailored sensory motor activities that are specifically designed to address the child's needs. The investigators believe this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the daily life activity and participation levels.

Start: May 2021

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.

Start: March 2020

Biofeedback Intervention in Adolescents With Autism Spectrum Disorder

This study consists of two phases, a cross-sectional and a interventional. The cross-sectional phase will provide more insight into the differences in the autonomic functioning between adolescents with autism spectrum disorder and their typically developing peers. During the longitudinal phase, the efficacy of an RSA biofeedback intervention will be examined in adolescents with autism spectrum disorder.

Start: November 2020

Combined Gut-brain Therapy for Children With Autism

CLINICAL ISSUE: Children with Autism Spectrum Disorder (ASD) are four times more likely to suffer with functional gastrointestinal disorders (FGIDs) than their neurotypical peers. The presence of FGIDs are linked to increased undesirable behaviour and ASD severity. Current behavioural approaches for ASD therapy do not alleviate the high comorbidity of FGIDs within this population. BACKGROUND: Dysfunction of the microbiome-gut-brain (MGB) axis has been implicated in pathogenesis of both ASD and FGIDs. Probiotics and prebiotics can modulate the gut microbiome and research has shown efficacy at improving gastrointestinal (GI) symptoms in children with ASD and neurotypical (NT) children with FGIDs. Gut-directed hypnotherapy (GDH) has shown utility in treating FGIDs in NT children and adults but has not yet been trialed in children with ASD. Targeting therapies to address the dysfunction of the bidirectional MGB axis will likely be more effective than either brain/behavioural or gut-based therapy alone. HYPOTHESIS: A synbiotic (prebiotic + probiotic mixture) with combined GDH will be more effective than a synbiotic alone at reducing GI symptoms in children with ASD aged 5.00 to 10.99 years over a 12-week period.

Start: December 2020

Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay

Headsprout is a commercially available computer-based reading program that teaches children fundamental reading skills, including phonics, fluency, and comprehension. The Headsprout reading intervention has been shown to be effective with children with various levels of reading skills, but it has not been rigorously tested in children with autism spectrum disorder (ASD). The purpose of this study is to evaluate the effectiveness of Headsprout in a pilot sample of 18 children with ASD and reading delays to serve as a foundation for a larger, future randomized clinical trial (RCT). Eighteen participants will be included in the study and randomly assigned to one of two groups; the first group will immediately receive treatment with the Headsprout reading program and the second treatment group will receive treatment after 12 weeks. Treatment sessions will occur for one to two hours, two to four days a week, for twelve weeks. The participants who do not receive treatment immediately will be asked to complete reading assessments periodically throughout their wait time. Participation may occur in clinic or via telehealth.

Start: October 2018

Adult Functioning Scale in Autism (AFS)

One of the major methodological obstacles to more informed policies and programs to support the successful transition to adulthood in autism spectrum disorder (ASD) is the absence of suitable measures of functional outcomes for adults. Currently available options include (a) measures designed for children that largely fail to capture concepts pertinent in adulthood or (b) the use of broad, often dichotomous outcomes (e.g., employed or not) that are insufficiently sensitive for monitoring progress. The objective of this project is to develop efficient and validated proxy and self-report measures of functional outcome for adults with ASD in the domains of employment, independent living, and social functioning, called the Adult Functioning Scale (AFS). This study will build on prior success in applying methods from the Patient-Reported Outcomes Measurement Information System (PROMIS®) to measurement development in ASD and will utilize a national sample of 500 adults with ASD capable of self-report and 500 caregivers of adults with ASD representative of the entire range of functioning level.

Start: June 2021

A Multi-site Comparison of Social Visual Engagement to Clinical Diagnosis for Autism Spectrum Disorder

This is an outpatient, multicenter, prospective, pivotal, double-blind, within-subject comparison trial of the Marcus Autism Center Investigational Device (MAC-ID) diagnostic procedure relative to the gold-standard (reference standard), current best practice expert clinician diagnosis (ECD) of Autism Spectrum Disorder (ASD) in children 16-30 months of age. Consecutive pediatric patients from the intended population (i.e. children 16-30 months of age) recruited from pediatric referrals and general advertisements will be the subjects of this trial. All subjects will undergo the MAC-ID diagnostic procedure (test). All subjects will also undergo the current best practice clinical diagnostic procedure, using standardized ASD diagnostic instruments and standardized developmental assessments, to produce the ECD of each child's ASD status (reference/gold standard). The study consists of a screening phase and diagnostic evaluation phase to assess the validity (sensitivity and specificity), safety, and effectiveness of the MAC-ID when used to diagnose ASD. Subjects will be enrolled in the trial for a period of 1 day. The trial will be completed in approximately 12 months. The overall study objective is to assess the safety and effectiveness of the MAC-ID to accurately diagnose ASD (primary analysis), as well as to accurately assess severity of ASD (secondary analysis) in very young pediatric subjects. The primary endpoints of this study are the diagnostic result from the MAC-ID and the diagnostic results from the ECD evaluation, both of which are either positive or negative for ASD. Each subject will undergo the Social Developmental Testing Device procedure and an examination by a clinical expert in the field of ASD diagnosis; all study center site personnel (including the expert clinicians responsible for the ECD evaluation) will be blinded to MAC-ID results.

Start: April 2018

Emotional Proactive Brain Study in Adults With Autism Spectrum Condition

This project aims: to study behavioral and cerebral activity specificity (latency and amplitude of evoked potentials, time frequency maps and cerebral connectivity) in predictive process (top-down regulation) during visual recognition of static and dynamic stimuli in adults participants with autism spectrum conditions compared to typically developed participants. to study the relation between predictive process and autonomous response (heart activity and electrodermal activity) to explore potential sex differences between autistic males and females

Start: September 2020

Sensory Integration Versus Fine Motor Intervention in Children With Autism

Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life. Delay in crawling, walking, and achieving other motor milestones are frequently observed in toddler hood. In addition, difficulties in fine motor skills are frequent in individuals with Autism spectrum.

Start: March 2021

Examining the Effects of a Job Entry Intervention

The current study will examine the efficacy of a virtual reality (VR) intervention entitled "Virtual Reality Job Interview Training (VR-JIT)" as well as a newly developed Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE) with adolescents diagnosed with autism spectrum disorder.

Start: September 2019

North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2

The "North Carolina Clinical Genomic Evaluation by Next-gen Exome Sequencing, 2 (NCGENES 2)" study is part of a larger consortium project investigating the clinical utility, or net benefit of an intervention on patient and family well-being as well as diagnostic efficacy, management planning, and medical outcomes. A clinical trial will be implemented to compare (1) first-line exome sequencing to usual care and (2) participant pre-visit preparation to no pre-visit preparation. The study will use a randomized controlled design, with 2x2 factorial design, coupled with patient-reported outcomes and comprehensive clinical data collection addressing key outcomes, to determine the net impact of diagnostic results and secondary findings.

Start: September 2018

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