177 Clinical Trials for Autism
Naturalistic developmental behavioral interventions (NDBIs) are a newer class of evidence-based interventions for young autistic children to promote their positive developmental or behavioral outcomes. These are often delivered by family members or other natural change agents given the emphasis on naturalistic transactions between an adult and a child. Despite the emerging evidence, there are practical difficulties that hinder wider dissemination and implementation of NDBIs, including low level of access to some of these branded, packaged NDBIs. To mitigate these difficulties related to access, we have created a series of video modules that demonstrate nine commonly used core components in NDBI strategies. In this study, caregivers will receive training and coaching using these modules and both synchronous and asynchronous coaching from a clinician. In this type 1 hybrid implementation trial, there are two groups of participants: (1) caregivers of young autistic children or children with other developmental disabilities/delays, (2) children, and (3) clinicians. Caregivers will meet with clinicians virtually weekly to (a) watch the newly developed NDBI videos that demonstrate the strategy use, (b) discuss how this might be applied to their own child, (c) receive individualized homework planning, (d) record and upload videos of their practice of strategy use with their own child, and (e) review the videos with clinicians to receive individualized feedback on their strategy use. This will occur for 10 weeks. Each session will be video recorded to assess the clinicians' intervention fidelity. After 10 weeks, pre-post tests will be conducted to assess parents' confidence on implementing these strategies, their child's social communication, and satisfaction of providers and caregivers. Qualitative data will also be collected via interviews with some selected participants to gain a deeper understanding of their perceptions.
The goal of this clinical trial is to investigate neural constructs related to anxiety symptoms in response to Facing Your Fears (FYF) treatment in autistic participants with co-occurring anxiety. Researchers will compare participants receiving immediate FYF intervention to those in the waitlist control group (receiving treatment as usual) to see if there are differences in neural constructs and anxiety symptom changes over the study period. Participants will: * Complete the Facing Your Fears (FYF) intervention if assigned to the immediate treatment group * Continue their usual treatment during a waitlist period if assigned to the control group, followed by the opportunity to participate in FYF intervention after the waiting period ends * Complete assessments of neural constructs, anxiety symptoms, and other measures
The purpose of this study is to test a novel, 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. The Investigators 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.
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.
Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)
The overall objective of this research is to determine whether parentese delivered in the video format (Aim 1) and in live interaction (Aim 2) facilitates novel word learning in autistic children and to investigate if there are factors that influence the effect of parentese on word learning (Aim 3).
The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds. What Will Happen: Researchers will compare two versions of the Pathways Intervention: * Version 1: Includes mutual gaze strategies. * Version 2: Does not include mutual gaze strategies. What to Expect: Participants will: * Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations). * Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.
Adolescents with ASD often have co-occurring mental health symptoms like stress, anxiety, and depression. The investigators are conducting this research study to develop interventions for adolescents with ASD that will improve co-occurring mental health symptoms.
The goal of this study is to pilot test a new educational intervention for organization members focused on suicide prevention for autistic people. The main questions it aims to answer are: * Does participating in the intervention increase participants' knowledge, skills, and actions to support suicide prevention for autistic people? * What feedback do participants have to help improve the intervention? Participants will: * engage in a four-part virtual educational intervention * answer questions via online survey before, after, and 3-months after the intervention * participate in an optional interview to provide feedback
Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.
The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.
Children on the autism spectrum sometimes have difficulty learning new words and using the newly taught information in different situations. In this study, the investigators are testing whether strategies that have been found to improve word learning in non-autistic children will also help autistic children. Specifically, the investigators aim to test whether autistic children learn words more successfully if novel words are taught by repeating the words to the child (re-study) or if the novel words are taught first with labeling each word and then quizzing the child (repeated quizzing). The main questions it aims to answer are: * When teaching nouns (names of exotic animals), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught words? * When teaching adjectives (visible features of objects, like a bumpy chair), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught adjectives? * Does the word learning condition (re-study vs. repeated quizzing) impact whether autistic children are more successful in demonstrating their knowledge of the newly taught words in different contexts? * Are autistic features related to patterns of word learning? Participants will: * Learn new words with half of the words being taught in one way (re-study) and the other half of the words being taught in the other way (repeated quizzing). * Participate in 5-minute and 1-week tests of the newly taught words to measure child learning. * Complete other language, thinking, and autism clinical assessments.
The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.
The investigators are looking to evaluate how effective a training program that focuses on character strengths may be in improving job maintenance skills in young adults. The investigators are examining the effects of this intervention in young adults who feel they would like to help in improving their satisfaction with work, and in keeping their jobs.
The goal of this clinical trial is to compare the effects of a specialized swimming and water-safety program (Sensory Enhanced Aquatics) and standard swimming lessons for autistic children. The main question\[s\]it aims to answer are: * Do Sensory Enhanced Aquatics and standard swimming lessons improve swimming and water-safety skills of autistic children? * Which participant characteristics are associated with the highest post-intervention swim skills and water safety across both groups? Participants will: * Complete questionnaires, motor, and swim tests before the intervention. * participate in 16, 30-minute Sensory Enhanced Aquatics lessons. * Complete a swim test after the intervention. * Complete an interview. Researchers will compare with participation in standard swim lessons to see if which bests teaches swimming and water-safety to autistic children.
The goal of this proposed trial will modify an existing toothbrushing app for teens with autism and compare toothbrushing outcomes with a control app. We have 2 specific aims: * During the 2-year UG3 phase, we will use the Discover, Design+Build, and Test Framework to modify our existing app and pilot the intervention. * During the 4-year UH3 phase, we will recruit 270 pre-adolescents and teens with autism ages 10 to 17 years, randomize participants to one of two arms, and compare outcomes. Participants will asked to use the app, complete surveys on REDCap, participate in feedback interviews and focus groups. Behavior change in the experimental group will be compared with that in the control group.
This study tests the effectiveness of the Early Start Denver Model (ESDM) in community agencies that serve young autistic children. The feasibility, usability and acceptability of the model will be explored. Understanding effectiveness of new evidence-based models will increase the quality of autism care available to more diverse children and families in more geographic locations.
The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).
The overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: a social communication intervention (Project ImPACT, Improving Parents as Communication Teachers) and a disruptive behavior intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes.
The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.
The goal of this clinical trial is to learn about the journey of families after their child's diagnosis of autism and to help parents understand autism and get the right treatments for their child. This study is for parents of children just diagnosed with autism who are: * Age greater than 1 and up to 5 years old; * Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND * Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma). The main questions it aims to answer are: * Whether parent coaching through Project AFECT leads to decreased parental stress and increased parental confidence; * Whether family navigation through Project AFECT leads to increased number of referrals to early intervention and educational services and reduced wait times to autism treatments; * Whether children whose parents receive Project AFECT intervention show increased language skills compared to children whose parents did not receive intervention. Participants will be asked to: * Complete surveys at enrollment and 3 and 6 months later. * Work with Project AFECT Coach. Researchers will compare control and intervention groups to see if Project AFECT leads to improved parent and child outcomes.
The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the detection of autism spectrum disorder in children 16-36 months of age.
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).
The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with ASD. The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with ASD (relative to full, grammatical utterances). The proposed project will investigate three specific aims: 1) Determine how single-word and telegraphic simplification affects language processing. 2) Determine how single-word and telegraphic simplification affects word learning. 3) Evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. Aim 1 will test the hypothesis that children with ASD will process full, grammatical utterances faster and more accurately than single-word or telegraphic utterances. Aim 2 will test the hypothesis that full, grammatical utterances will support word learning better than telegraphic or single-word utterances. Aim 3 will test the hypothesis that language and cognitive skills significantly moderate the effects of linguistic simplification on language processing and word learning in young children with ASD.
The goal of this study is to conduct the first community-based implementation of the STEPS program and test feasibility and preliminary impact. After first working with stakeholders to refine and optimize the program we will launch a Hybrid Type 1 open trial, targeting 25 transition-age youth (TAY) with ASD.