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.
Study Type
OBSERVATIONAL
Enrollment
6,604
Collection of saliva via swab for miRNA processing
Includes Vineland Adaptive Behavior Scale or equivalent
Survey that collects basic medical and demographic information
Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent
Includes Mullens Scales of Early Learning, Stanford Binet Intelligence Scales, Wechsler Preschool and Primary Scale of Intelligence (WPPSI), Bayley Scales of Infant Development or an equivalent
University of California - Irvine
Santa Ana, California, United States
RECRUITINGMarcus Autism Center/Emory University
Atlanta, Georgia, United States
RECRUITINGRUSH University
Chicago, Illinois, United States
NOT_YET_RECRUITINGUniversity of Massachusetts Medical School
Worcester, Massachusetts, United States
RECRUITINGUniversity of Rochester
Rochester, New York, United States
RECRUITINGQuadrant Biosciences
Syracuse, New York, United States
ACTIVE_NOT_RECRUITINGSUNY Upstate Medical University
Syracuse, New York, United States
NOT_YET_RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGMetroHealth Medical Center
Parma, Ohio, United States
RECRUITINGNationwide Children's Hospital
Westerville, Ohio, United States
RECRUITING...and 6 more locations
Salivary miRNA Profile
Measures of miRNA abundance in saliva
Time frame: At the time of collection (from 18 months to 6 years 11 months of age)
DSM-5 Diagnosis
Confirmation of participants meeting or not meeting the DSM-5 Criteria for a diagnosis of Autism Spectrum Disorder
Time frame: At the time of the diagnostic evaluation
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