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Autism clinical trials at UC Health
25 in progress, 13 open to new patients

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

    open to eligible people ages 16 months to 30 months

    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.

    at UCSF

  • A Study of Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder

    “We hope to learn how to support families concerned with their infants’ development.”

    open to eligible people ages 5 months to 12 months

    Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.

    at UC Davis

  • A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)

    open to eligible people ages 5-17

    This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan (RO5285119) in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). Enrollment will be staggered, starting first with adolescents (aged 13 to 17 years) and then with children (aged 5 to 12 years). Initially, a first cohort of approximately 24 adolescents will be enrolled together. Based on pharmacokinetic evaluation, safety, and tolerability in the first adolescent cohort and determined final doses, enrollment of adolescents will resume and the enrollment of a first cohort of approximately 24 children (aged 5 to 12 years) can commence. Based on acceptable safety and tolerability in the first children cohort and determined final doses, enrollment of children will resume.

    at UCSF

  • Building Better Bridges Randomized Control Trial

    open to all eligible people

    In this study, the investigators will randomize 20 families per site (across 4 sites) to be in the BBB Transition Passport Only Group or BBB Intervention Group. Both groups will receive the BBB Transition Passport, which include the Transition Checklist, Student Snapshot, Parent/Caregiver Guide, and Student Guide. In addition to receiving the Transition Passport, the BBB Intervention Group will also receive coaching support to implement these resources. This coaching will include a member of the research team assigned as a coach for each family. This coach will introduce the resources to the family, briefly teach them fundamental information about the transition process, provide brief coaching phone calls, and guide parents in using the tools and requesting help from the child's provider(s). The investigators will be testing the differences between these two groups in terms of: 1) quality of the transition as reported by the parent and teacher, 2) self-efficacy of the parent during the transition process, 3) child school engagement and behavior during the transition as rated by the teacher and parent, and 4) the quality of the child's team to communicate about information important to the child's transition.

    at UC Davis

  • Combination Treatment for Augmenting Language in Children With ASD

    open to eligible people ages 5-11

    The study will consist of two main elements: the enrollment of 72 children aged 6-11 years with ASD and low language competency to receive a thrice-weekly one hour language intervention for 12 weeks; and, beginning at the same time, subjects will be equally randomized to receive either aripiprazole (Abilify) (flexibly dosed from 2-10 mg per day) or placebo for 12 weeks.

    at UCLA

  • Detection of ASD at the 1st Birthday as Standard of Care: The Get SET Early Model

    open to eligible people ages 12 months to 36 months

    According to a recent report from the Centers for Disease Control, most children with ASD do not receive a diagnosis and begin receiving treatment until well after their 4th birthday, which is unfortunate given that many connections between brain cells have already been established by that age. This program will test a model called Get S.E.T. Early (S=Screen, E=Evaluate, T=Treat) in both San Diego and Phoenix, designed to detect, evaluate, and treat ASD within the first 2 years of life. In this proposal 7,500 toddlers from the general population will be screened in San Diego and Phoenix (total 15,000) using the CSBS IT Checklist (Wetherby & Prizant, 2002) at well baby check-ups using a "triple screen" approach wherein toddlers are screened at three ages starting at 12 months. Investigators predict that providing screening tools with clear cut-off scores and guidelines for automatic referral for both evaluation and treatment will result in dramatically lowering mean age of detection in Phoenix from 4-5 years down to 1-2 years. Investigators also predict that using repeat screening at 12, 18, & 24 months in combination with automatic referral options via technology (i-Pads) will result in an increase in the number of ASD toddlers detected by 24 months relative to a single time point screen using traditional paper screens.

    at UCSD

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

    open to eligible people ages 12 months to 36 months

    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

  • Improving Dental Care and Oral Health in Children With Autism Spectrum Disorder

    open to eligible people ages 3-13

    A randomized controlled trial (at sites) comparing the efficacy of the established AIR-P Dental Toolkit (control condition) to a combined regimen involving the Dental Toolkit and parent-mediated behavioral intervention (intervention condition) to improve home dental care, oral health outcomes, and dental office visit experiences.

    at UC Irvine

  • Measuring Brain Inflammation in Autism

    open to eligible males ages 18-35

    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

  • MIND THE GAP

    “Are you interested in receiving information and educational materials about autism and the service system?”

    open to eligible people ages 2 years and up

    There has been a lack of research on the unique needs of families with autism in the African-American and Latino communities. The process of screening, evaluation and treatment for children with autism can be long and arduous, especially in these communities. This often means that the best interventions for children with autism are not reaching minority communities. For many families, the complexity of the services system leads to a long wait after the initial diagnosis before accessing intervention. This means that the children have delayed access to treatment. Mind the Gap is a study that seeks to provide immediate and culturally appropriate support for families who have just received diagnosis but have yet to receive treatment. This support will be provided in families' native languages and, through the use of phone and video sessions, can accommodate busy schedules. Mind the Gap participants will be randomized to receive one of two conditions, which are 1.Resources only (online training modules and paper or on line resource lists, but no peer coaching) 2. Peer coaching (will receive all online training access). The peer coaches will be recruited from local parent support agencies. They will not be professionals in the field of ASD, but they will be trained by the research group on how to access the online tools and how to work whith families. They will contact the participants via phone or video conference on a weekly basis and an in- person visit per month for 3 months. Peer coaches will have a monthly call with participants for an additional nine months.We hope that this study will help the African American and Latino communities receive services sooner than currently reported. We also hope that in the future, parent organizations will use these tools to help families that have recently received an ASD diagnosis will us navigate the complex system of attaining services.

    at UC Davis

  • Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

    open to eligible people ages up to 21 years

    Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

    at UCSD UCLA

  • Study of anxiety treatments in Autism Spectrum Disorder (ASD)

    “How can therapy or medication better alleviate symptoms of anxiety and/or autism?”

    open to eligible people ages 8-12

    Approximately 40%-80% of children and adolescents with autism spectrum disorder (ASD) exhibit clinically significant anxiety symptoms. These symptoms are associated with increased social deficits, depression, irritability, and stereotyped and self-injurious behaviors. Children and adolescents with anxiety also frequently avoid potentially stressful situations, thereby missing opportunities to learn important new skills. However, there is a lack of clarity about how to differentiate ASD and anxiety symptoms. There is also little known about how anxiety manifests in those with ASD and intellectual disability (ID). The goal of this study is to investigate these issues in order to make interventions more precise, more personalized, and more likely to promote positive outcomes While there is no doubt that anxiety is a very serious issue for those with ASD, what to do about this problem is less clear. Multiple small trials have provided promising evidence that selective serotonin reuptake inhibitors (SSRIs) and cognitive behavior therapy (CBT) might reduce anxiety in those with ASD. However, this work is in its early stages. In this study we will conduct a study in children with ASD and clinically significant anxiety ages 8-12 to compare efficacy of these different treatment types.

    at UC Davis

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

    open to eligible people ages 18 years and up

    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 UCSD UCLA

  • A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

    Sorry, not currently recruiting here

    This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).

    at UCLA UCSF

  • A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)

    Sorry, not currently recruiting here

    This is a non-drug study seeking to characterize different scales to measure repetitive and restrictive behaviors in different ASD sub-populations over time. This study will also explore the use of digital biomarkers.

    at UCLA

  • An Open Label Study of 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

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

    Sorry, in progress, not accepting new patients

    The purpose of this study is to characterize the developmental phenotype of ASD and ID and identify biomarkers using advanced MRI methodology predictive of ASD and ID presence and severity in pediatric 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

  • Early Biomarkers of Autism in Infants With Tuberous Sclerosis Complex (TSC)

    Sorry, in progress, not accepting new patients

    The investigators are enrolling 3-12 month old infants with a diagnosis of tuberous sclerosis complex (TSC) for a new study on early markers of autism. The study is looking for early signs for autism in a population (TSC) where autism is common. The goal of this project is to use behavioral testing, MRI and EEG techniques to identify children at risk for developing autism starting at 3 months of age and continuing until 36 months of age. Throughout the study, the investigators will recommend Early Intervention services for any child who shows early signs of autism.

    at UCLA

  • Extension for Community Healthcare Outcomes Autism Replication Evaluation

    Sorry, in progress, not accepting new patients

    ECHO Autism was intended to assess rigorously the impact of a 12-session telemedicine training program on participating Primary Care Providers (PCP) knowledge, clinical behavior, and self-efficacy in the screening and care of children with Autism Spectrum Disorder (ASD). Each session is referred to as an "ECHO clinic".

    at UC Irvine

  • Intervention Effects of Intensity and Delivery Style for Toddlers With Autism

    Sorry, in progress, not accepting new patients

    A multi-site randomized study of intensive treatment for toddlers with autism. This project proposes a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention intensity and intervention style delivered for 12 months, on the developmental quotients (primary outcome) of very young children with ASD ages 12-30 months old and their families, and the effect of children's initial vocal skills, developmental rates and autism severity on their response to intervention. A second study will examine whether the effects of the Early Start Denver Model intervention are sustained over a three year period for 6-7 year old children who previously were enrolled in a two year study that compared ESDM treatment to usual community interventions.

    at UC Davis UCLA

  • Natural History Study of Individuals With Autism and Germline Heterozygous PTEN Mutations

    Sorry, in progress, not accepting new patients

    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

  • Pediatric Open-Label Extension Study

    Sorry, in progress, not accepting new patients

    This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

    at UCSF

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

    Sorry, accepting new patients by invitation only

    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

  • The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)

    Sorry, in progress, not accepting new patients

    The Centers for Disease Control and Prevention estimates that 1 in 59 U.S. children have been diagnosed with an autism spectrum disorder (ASD). Peer relationships, social skills, and repetitive behaviors are a challenge for those with ASD. Exercise in the ASD population has been examined as a means to improve some of these challenges for children with ASD. This research study will try to see if a structured exercise program called CrossFit Kids can help with these challenges. This study is potentially beneficial in developing an exercise program for children with ASD that can help promote social skill development, reduce stereotypical behaviors, and provide overall health benefits.

    at UC Davis

  • Use of Virtual Reality Game Playing During Venipuncture (blood draw)

    “Using virtual reality game playing during blood draw may help distract children, especially those with developmental delays.”

    Sorry, accepting new patients by invitation only

    To evaluate the impact of using virtual reality, VR, game playing on successful completion and reduction of distress and pain in pediatric venipuncture, and to increase adherence in obtaining the desired blood volume.

    at UC Davis

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