Clinical Research

Through our extensive Clinical Research Program, the Seaver Autism Center for Research and Treatment has gained significant expertise in the medical and behavioral treatment of children, adolescents, and adults with autism spectrum disorder and related conditions.

Our group has developed an effective experimental therapeutics program in psychosocial and psychopharmacological treatment approaches, incorporating established and novel treatment approaches. Our clinicians provide state-of-the-art assessments, among the best available in the world today. Their work also supports autism research across programs at the Icahn School of Medicine at Mount Sinai and enhances communication between the various programs and individual investigators, generating new ideas and innovative opportunities for outstanding clinical and basic science research.

The Seaver Autism Center is conducting the following clinical trials:

Study of Oxytocin in Autism to Improve Reciprocal Social Behavior (SOARS-B): The goal of this project is to evaluate intranasal oxytocin as a treatment for improving social difficulties in individuals with autism spectrum disorder. This is a phase 2 clinical trial using a multi-site, placebo-controlled, parallel group design followed by an open label extension phase. Children ages 3-17 may be eligible.

A Pilot Treatment of Insulin-like Growth-Factor-1 (IGF-1) in Autism: This project is piloting the use of Insulin-Like Growth Factor-1 (IGF-1) as a new treatment for children between the ages 5-12 with autism spectrum disorder (ASD). A previous treatment study with IGF-1 in children with a single gene cause of ASD (Phelan-McDermid syndrome) suggests that IGF-1 can improve symptoms of social withdrawal and repetitive behaviors.

Piloting Treatment with Intranasal Oxytocin in Phelan-McDermid Syndrome: The goal of this study is to examine the efficacy, safety and tolerability of intranasal oxytocin as a novel treatment in Phelan-McDermid Syndrome (PMS) to improve impairments in attention, social memory, socialization, language, and repetitive behaviors. Children ages 5-17 may be eligible to participate.

The Seaver Autism Center is conducting the following behavioral, neuroimaging, and genetic studies:

Development of Behavioral and Neural Biomarkers for Autism Spectrum Disorder Using a Genetically Defined SubtypeThe research team at the Seaver Autism Center is seeking children to participate in a study to examine sensory processing in children with autism spectrum disorder and Phelan-McDermid syndrome using brain wave measurement and sensory assessments. The brain wave measurement involves placing three non-invasive electrodes on your child’s head using a paste that dissolves in water and your child will be asked to look at patterns on a computer monitor for approximately 10-minutes. Your child will also complete a play-based sensory observational assessment and you will complete questionnaires about your child’s sensory preferences. Typically developing children are also eligible to participate.

Developing Scalable Measures of Behavior Change for ASD Treatment: The goal of this study is to develop and evaluate a new instrument for measuring change in social-communication behaviors in verbally fluent children with autism spectrum disorder. Participating in the study involves evaluating cognitive abilities, autism symptoms, social behaviors, treatment outcomes and adaptive functioning. Children between the ages of 4 and 16 may be eligible to participate.

Improving Access to Care for Minority Youth with Autism Spectrum Disorder Using a Family Peer Advocate Model: The Seaver Autism Center is evaluating the use of Family Peer Advocates (FPA) to improve the health and well-being of children with autism spectrum disorder. Family Peer Advocates (often referred to as Parent Advocates) are being used across child service delivery systems to improve engagement in care and collaboration between caregivers and service providers. The goal of this study is to expand the resources available to families within ASD service systems, with a focus on helping African-American and Latino caregivers understand ASD and available treatment options, decrease obstacles in service use, collaborate with service providers, and actively pursue treatment goals at home.

Mapping the Genotype, Phenotype, and Natural History of Phelan-McDermid Syndrome: The goal of this study is to gain a better understanding of Phelan-McDermid syndrome (PMS). This is a multi-center research study conducted as part of the Rare Disease Clinical Research Network (RDCRN) and sponsored by the National Institutes of Health (NIH).  Individuals between the ages of 3-21 diagnosed with PMS are eligible to participate in this study.

Mapping the Genotype and Phenotype in Individuals with FOXP1 Mutations: The goal of this study is to gain a better understanding of the impact of FOXP1 mutations in children and adults. The study will involve a medical evaluation, neurological examination, dysmorphological examination, detailed behavioral testing and imaging.

The Autism Sisters Project: The Autism Sisters Project will collect behavioral and genetic information from all family members including siblings and parents of individuals with ASD. If you agree to participate, all family members will complete activities looking at thinking and language abilities. You will also be asked to complete several questionnaires and a provide a saliva sample for genetic analysis.

Brain Imaging of Children with Developmental Delays or Autism: This study is examining the ways in which the brains of children with developmental delay or autism respond to speech and other sounds. We are also studying brain structure and the connections between brain regions. Children ages 2-17 may be eligible.

Genetic Testing: Genetic testing is available to all patients who participate in Seaver Autism Center research. Our clinicians work directly with our clinical geneticists to carry out basic and advanced genetic analyses on all consenting families. Our genetic testing can determine an etiological diagnosis in more than 20 percent of families, and this information may have important ramifications for predicting recurrence risk in families and identifying new genes in autism.

Autism BrainNet: The Icahn School of Medicine at Mount Sinai is one of the nodes of Autism BrainNet, a network of research institutions dedicated to groundbreaking brain research in autism.