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Autism clinical trials at University of California Health

26 in progress, 14 open to eligible people

Showing trials for
  • Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool

    open to eligible people ages 18 months to 42 months

    The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. The TAP was developed at VUMC by a team of clinical psychologists with expertise in the early identification of ASD. The TAP has been studied in controlled laboratory settings, with high levels of family and clinician satisfaction, as well as excellent agreement with blinded comprehensive ASD evaluation. The TAP has also been used to complete direct-to-home telemedicine assessments during the COVID-19 pandemic. However, the investigators have not yet compared direct-to-home assessments using the TAP with gold standard, in-person ASD assessments. It has also not yet been studied in a diverse sample of families or with providers outside of VUMC. This study will allow the investigators to address those gaps.

    at UC Davis

  • AIR-B4: Mind the Gap

    open to eligible people ages 2 years and up

    The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of an implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention, and active coaching for up to 12 sessions as dictated by the intervention procedures during a time span of 6 months. The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self-advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities). For MTG, peer navigators (staff working in an organization that already works with parents) and parents (with children with ASD) will meet via phone or video conference for up to 12 sessions within a 6 month span (an hour each time). They will go over sessions that were created by the research group that help parents understand the system of acquiring services. The total time commitment for peer navigators is about 18 hours and for parents with children with ASD is about 8.5 hours. Identified families connected to the community organization will be matched with one peer navigator who will then guide and support the caregiver through completion of the MTG modules with active coaching of the family. Family needs and preferences will guide topic selection. Active coaching will occur via zoom, or over the phone, based on family preference and some recorded sessions will be shared with the research group for analyses. Mind the Gap will be available in English, Spanish, and Korean.

    at UC Davis

  • Boosting Language Outcomes of Minimally Verbal Children With ASD (BLOOM)

    open to eligible people ages 48 months to 66 months

    In this project, the investigator will test the effect of augmenting an evidence based joint attention intervention (JASPER) with a motor-sound system intervention (PROMPT) compared to JASPER only on speech and language outcomes. The investigator will model change over a year to determine the percentage of children who cross the hurdle from single words to word combinations by Kindergarten. The proposed research will foster the understanding of the mechanisms underlying speech heterogeneity in ASD, thereby ultimately contributing to the development of more personalized, efficacious interventions. Upon qualification to the study (after entry assessments), the child will be randomized to receive JASPER alone (play-based intervention) or JASPER plus PROMPT (both play-based and speech-based interventions). The active intervention will last for 12 weeks, 60 minute sessions twice a week. There are assessments scheduled at entry (6.5 hours), end of study (exit-2.5 hours), 3 month follow up (2 hours), and when the child turns 6 years of age (2 hours). The total time commitment per participant is 37 hours.

    at UCLA

  • CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings

    open to eligible people ages 6-14

    This study is a 4-year randomized, controlled trial comparing cognitive behavioral therapy (CBT) to usual clinical care for children (aged 6-14 years) with autism and emotional dysregulation (e.g., irritability, anxiety). We will randomly assign 50 mental health clinicians, each treating 2 youth (N = 100 youth total), to CBT program for emotional dysregulation and core autism symptoms with weekly live consultation with an expert or to usual clinical care augmented by self-instruction in CBT, in a 1:1 allocation. The CBT manual is well-supported in our efficacy research, has been replicated in other centers, is free/open-access (meya.ucla.edu), and has user-friendly digital and traditional print materials for mental health clinicians (e.g., psychologists, counselors) to use in preparing for and conducting therapy sessions. The primary outcome measure will be assessed weekly. Additional assessments will occur at Screening, Mid-treatment, Post- treatment and 3-month Follow-up.

    at UCLA

  • Dance for Children With Autism

    open to eligible people ages 8-12

    Motor impairments are prominent in individuals with autism spectrum disorder (ASD) and other neurodevelopment disorders, and these impairments often impact the individual's ability to engage in organized physical activity programs (OPA). While many studies have identified dance and creative movement to be retrospectively and anecdotally therapeutic, there remains a paucity of literature regarding outcomes associated with these programs, and specifically, their impact on (1) perceived and objective gross and fine motor skills, (2) perceived ability to succeed in related or divergent goals or tasks, (3) quality of life for affected individuals and their caregivers. (4) adaptive function and socialization, (5) social communication This study explores the impact of organized dance and creative movement classes on children with autism (ages 8-12) and their caregivers. Participants will complete a set of surveys and assessments designed to measure the above metrics (labeled 1, 2, and 3) at their first study visit. This initial assessment is expected to take place within two weeks prior to beginning the intervention (either a wait period or a series of 1-hour dance classes, which children will attend weekly for 10 weeks). The second and final study visit will consist of a similar set of surveys and assessments designed to measure the same metrics within the two weeks following completion of the dance class series. Participants who have completed the wait period at this point will then begin their set of 10 weekly dance classes. Expected duration of participation in the study is no longer than 14 weeks in total.

    at UCLA

  • Evaluating BOSCC and ELSA as Outcome Measures in the Context of a JASPER Intervention Trial

    open to eligible people ages 18 months to 5 years

    Research teams in Boston University, UCLA, and Weill Cornell will recruit 90 participants in 3 years (10 participants per site per year) and evaluate JASPER, play-based intervention, using the BOSCC and ELSA-T. Participants will be randomized to receive JASPER facilitated either by a clinician or the caregiver. After 10 weeks, the participants will be evaluated using the CGI to determine if they are "responders" or "non-responders". Nonresponders will be given a mix of clinician and caregiver-facilitated JASPER and responders will remain the course for the following 10 weeks. Coding of the BOSCC and ELSA-T will be the outcome measures and change will be evaluated throughout the study.

    at UCLA

  • Early Start Denver Model in Community Programs Serving Young Autism

    open to eligible people ages 12 months and up

    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.

    at UC Davis

  • Family, Responsibility, Education, Support, and Health for Families With a Child With Autism

    open to eligible people ages 6-12

    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).

    at UCSD

  • ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

    open to eligible people ages 12-45

    ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.

    at UCSF

  • PRISM Intervention Study

    open to eligible people ages 36 months to 59 months

    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).

    at UCLA

  • Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)

    open to eligible people ages 18 months and up

    The purpose of this study is to characterize the developmental phenotype of ASD and ID and to identify biomarkers using advanced MRI methodology and electrophysiological biomarkers of synaptic function and connectivity predictive of ASD and ID presence and severity in patients with TSC. In addition, this study will be establishing infrastructure for the collection and storage of human bio-specimens, including genetic material, from TSC patients and their family members with ASD.

    at UCLA

  • Individuals With Autism and Germline Heterozygous PTEN Mutations

    open to eligible people ages 18 months and up

    The purpose of this study is to determine cross-sectional and longitudinal medical, behavioral, and cognitive differences between PTEN ASD and other groups, as well as to identify cognitive, neural systems, and molecular biomarkers specific to PTEN ASD. In addition, this study will be creating and maintaining a biorepository and linked phenotypic database for PTEN ASD.

    at UCLA

  • Autism Biomarkers Consortium for Clinical Trials: Confirmation Study

    open to eligible people ages 6-11

    This is a multicenter longitudinal study that aims to validate a set of measures that were previously identified as promising candidate biomarkers and/or sensitive and reliable objective measures of social function in ASD for potential use in clinical trials. The confirmation study will repeat the data collection and analysis protocols from the original ABC-CT study. This confirmation study will recruit 200 ASD and 200 TD comparison participants who are 6-11 years old, matching the overall sample size but providing a larger normative reference sample and greater statistical power for group comparisons.

    at UCLA

  • Validation of a Salivary miRNA Diagnostic Test for ASD

    open to eligible people ages 18 months to 7 years

    This study involves sample collection to identify biomarkers relating to Autism Spectrum Disorder(ASD) in the saliva of children who are between the ages of 18 months to 6 years and 11 months. Participants will at each timepoint have a non-invasive saliva swab collected and complete a brief demographic and medical history questionnaire as well. Children in the pediatric/provider setting who will receive a referral for an ASD diagnosis because they were determined to have a suspicion of developing ASD will be enrolled in the study. Children will also be enrolled in the specialist evaluation setting where they will receive a DSM-5 diagnosis. A subset of both enrollment cohorts will also be followed up with at a third time point in which their diagnosis will be confirmed, and information about any ongoing treatment will be gathered.

    at UC Irvine

  • AIRB-4: Self-Determined Learning Model of Instruction

    Sorry, not currently recruiting here

    The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determined Learning Model of Instruction) with and without the addition of our implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention and active coaching as dictated by the intervention procedures. The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self-advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities). For the SDLMI, school personnel will be trained to work with adolescents with ASD using the SDLMI model. This model will help students with ASD set their own goals and help attain them. The total time commitment for the school personnel is 1 school year (2 semesters) for about 47 hours. The total time commitment for the parent of the student with ASD is about 1 hour (sign consent/fill out demographic survey). The total time commitment for the student with ASD is 1 school year (2 semesters) for about 25.25 hours.

    at UC Davis

  • CM-AT for the Treatment of Children With Autism

    Sorry, in progress, not accepting new patients

    This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.

    at UCSF

  • Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care

    Sorry, not currently recruiting here

    The goal of this collaborative R01 is to demonstrate the therapeutic value and community-wide implementability of an early intervention (EI) platform for toddlers with autism spectrum disorder (ASD) that is completely virtual, from recruitment through intervention. This platform-Early Social Interaction Mobile Coaching (ESI-MC) deploys individual telehealth sessions with coaching and feedback to help families embed intervention in everyday activities. Specifically, the investigators will conduct an effectiveness trial of ESI-MC to address the important question of whether starting evidence-based intervention earlier leads to better outcomes than starting later. The investigators will address this question by using a modified stepped wedge design and blended implementation research to analyze data obtained with ESI-MC start at 18, 24, or 30 months. The investigators will diagnostically ascertain 240 children from a pool of 360 18-month-olds with early signs of autism, 30 in each of 8 US regions (Central and SW Florida; Atlanta, GA; suburbs of Philadelphia, PA; New York City, NY; Cincinnati, OH; Chicago, IL; Seattle, WA; and Los Angeles, CA). Research participants will be recruited using a new virtual platform-My Baby Navigator-linking a new surveillance and screening tool, an app to upload video-recorded home observations and telehealth intervention sessions, and a package of educational resources. The 240 children will be randomly assigned to one of three ESI-MC timing groups. ESI-MC will be delivered by community-based early intervention providers (EIPs) currently working within the the early intervention system in the recruitment regions. The investigators will measure child active engagement and social communication change every 6 months as the primary outcome variables. Outcome measures of developmental level, autism symptoms, and adaptive behavior will be examined to measure differential treatment effects. Maximizing the use of mobile technology, ESI-MC offers the prospect of a community-viable, scalable and sustainable treatment to improve EI services for toddlers with ASD, particularly among minority and low-resource communities.

    at UCLA

  • Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes

    Sorry, in progress, not accepting new patients

    The overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about ASD in their infants. In this study, we will gather exploratory data related to the potential of two telehealth tools: 1) The Telehealth Evaluation of Development for Infants (TEDI); and 2) "Help is in Your Hands" (HIIYH), a set of video materials and information on interactive strategies parents can use to support their child's communication development. We will recruit families participating in an ongoing study using the TEDI (R21 HD100372, PI: Talbott) to evaluate infants' behavioral development. As families exit the parent TEDI study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (HIIYH) for parents or no additional materials. After 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. When children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.

    at UC Davis

  • Heterogeneity in ASD: Biological Mechanisms, Trajectories, and Treatment Response

    Sorry, in progress, not accepting new patients

    Parent-mediated interventions often target social communication in young children with ASD, although to date studies yield inconsistent effects. One reason for the limited evidence may be the considerable heterogeneity in both parent and child characteristics that affect the fit of intervention to family and ultimately influence treatment outcome. For parents, these factors might include stress associated with the uncertainty of their child's diagnosis, caregiver expectations for the intervention itself, and a parent's own style of interaction that may be influenced by milder but qualitatively similar ASD characteristics, known as the broad autism phenotype (BAP). For children, these factors might include nonverbal DQ, language, or sensory impairment. The fit between type of intervention and optimal outcome for parent and child is an understudied, yet essential component of early intervention that may be susceptible to the influence of heterogeneity in the parent and child. One approach to addressing this variability is to implement an adaptive intervention approach that seeks to capitalize on heterogeneity among children and parents. Utilizing an adaptive treatment design, the current study tests the optimal sequence of intervention delivery and specific parent and child characteristics that may moderate treatment success in three 10-week stages of intervention. The first phase will randomize parents and children to a parent education condition, consisting of a parent support and education group focused on social communication development, or to a parent mediated and therapist delivered condition involving coaching of the parent with their child in social communication strategies. Phase 2 involves re-randomizing parents and children to maintain the same treatment arm, or change to the opposite arm to test the optimal sequence of intervention delivery and specific parent and child characteristics that may moderate treatment success. In the final phase, dyads are randomized to different maintenance arms, each comprised of 5 sessions with one involving skype and text contact, the other in -home visits, to explore how best to maintain treatment gains once the active intervention phase is complete. This study has the potential to dramatically improve child social communication outcomes by individualizing and personalizing parent intervention approaches with very young children, a high priority need of the Interagency Autism Coordinating Council and NIH.

    at UCLA

  • Management of ADHD in Autism Spectrum Disorder

    Sorry, not currently recruiting here

    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.

    at UC Irvine

  • Measuring Brain Inflammation in Autism

    Sorry, currently not accepting new patients, but might later

    Autism spectrum disorders (ASD) are highly disabling, persistent neurodevelopmental disorders. There are no available treatments for core symptoms of ASD or biologically-based clinical biomarkers. Emerging evidence indicates that levels of brain inflammation are increased in ASD. In particular, recent work implicates hyperactivity of microglial cells, the resident immune cells of the brain. However, the functional consequences of microglial activation remain unknown. This study will measure microglial activation in ASD using positron emission tomography (PET) brain imaging. Adult males with ASD (n=15) and healthy controls (n=15) will be recruited for this study and undergo comprehensive clinical and behavioral baseline assessment. All subjects will then undergo baseline PET imaging using a radiotracer that labels activated microglia. Subjects with ASD will then undergo 12-week open label treatment with minocycline, an FDA-approved antibiotic thought to block microglial activation. PET imaging will be repeated at 12 weeks to confirm target engagement. A subset of control subjects will also undergo repeat PET imaging to determine test-retest reliability. During minocycline treatment, ASD subjects will be evaluated every 2 weeks for safety, clinical impression, behavioral functioning, and measures of cognition. Results will provide important information regarding the relationship between levels of brain inflammation, cognitive and behavioral function in ASD.

    at UCLA

  • Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes

    Sorry, in progress, not accepting new patients

    Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests. The average age of diagnosis in the US is after the fourth birthday. However, children who start ASD-specific early intervention have better outcomes than children start later. The current study will address a gap identified by the US Prevention Services Task Force, namely that children detected through screening respond positively to early intervention. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. Local pediatric providers will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Across all sites, 8,000 children will be recruited through their participating pediatric practice. Qualifying children will receive up to one year of early intensive behavioral intervention, after getting an ASD diagnosis. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.

    at UC Davis

  • Proof of Mechanism Study for the Treatment of Social Anhedonia in ASD

    Sorry, in progress, not accepting new patients

    This project will use the experimental medicine approach of a Phase IIa Proof of Mechanism 16-week, randomized, double-blind, controlled trial of L-DOPA versus placebo administration in combination with a 16 week social skills training group in order to: 1) identify differences in social reward processes in adolescent and young adult ASD participants versus healthy controls as measured by fMRI activation in reward circuitry; 2) provide evidence of dopaminergic moderating effects on social reward components in ASD with greater pre- to post-treatment changes expected in the subjects randomized to L-DOPA versus placebo; 3) examine the hypothesis that baseline readouts of putative dopamine signaling (wanting activation responses) will predict the extent of fMRI reward-related activation changes pre- to post-treatment; and, 4) examine the proposed relationship between pre- to post- L-DOPA fMRI reward changes and changes in individual self-report ratings of social wanting and ratings of videotaped positive affect in a structured interaction with an examiner. The study will enroll 56 participants with DSM-5 ASD between the ages of 13-30 years of age and 18 healthy control participants without histories of psychopathology for baseline comparisons.

    at UCLA

  • Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

    Sorry, accepting new patients by invitation only

    This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.

    at UCSD

  • Translating Evidence-based Interventions for ASD: Multi-Level Implementation Strategy

    Sorry, accepting new patients by invitation only

    The purpose of this study is to test the effectiveness of the "Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy" (TEAMS) model on provider-level implementation outcomes when used to enhance provider training in two evidence-based interventions for children with autism spectrum disorder (ASD). The TEAMS- Leadership Institute (TLI) module includes training to program/school district leaders in implementation of EBI, and the TEAMS Individualized Provider Strategy for Training (TIPS) module applies Motivational Interviewing strategies to facilitate individual provider behavior change. TEAMS will be tested in combination with two clinical interventions in two community service setting contexts (1) AIM HI intervention in mental health programs and (2) CPRT intervention in schools. It is expected that the addition of TLI and / or TIPS will improve use of EBI by community providers.

    at UC Davis UCLA UCSD

  • Cannabidiol to Treat Severe Behavior Problems in Children With Autism

    Sorry, in progress, not accepting new patients

    There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.

    at UCSD

Our lead scientists for Autism research studies include .

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