Autism Spectrum Disorder, Developmental Delay
Conditions
Keywords
Autism Spectrum Disorder, ASD, Saliva, Biomarkers
Brief summary
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.
Interventions
OTHERSalivary Collection
Collection of saliva via swab for miRNA processing
OTHERAdaptive Assessment
Includes Vineland Adaptive Behavior Scale or equivalent
OTHERMedical and Demographic questionnaire
Survey that collects basic medical and demographic information
OTHERAutism Assessment
Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent
OTHERIntellectual Development Assessment
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
Sponsors
University of California, Irvine
Holland Bloorview Kids Rehabilitation Hospital
Children's Hospital of Philadelphia
MetroHealth Medical Center
University of Rochester
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati
University of Pittsburgh
University of Massachusetts, Worcester
Children's Hospital Los Angeles
Prisma Health-Upstate
University of Virginia
State University of New York - Upstate Medical University
Rush University
Seattle Children's Hospital
Drexel University
Emory University
Quadrant Biosciences Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Months to 7 Years
Healthy volunteers
No
Inclusion criteria
* 18 through 83 months old * The study will include children at risk for ASD as defined by meeting one or more of the following criteria: * flagged positive on a developmental screening tool (see below for assessment cut off scores) * the child has a biological sibling with ASD * Significant provider concern based on parent report noted in the child's medical chart at the time of the appointment. * Significant parental concern
Exclusion criteria
* Feeding tube dependence * Active periodontal disease * Confounding neurological condition (i.e. cerebral palsy, epilepsy) * Sensory impairments (i.e. blindness or deafness) * Acute illnesses (i.e. upper respiratory infection) * Currently on antibiotics * Had taken antibiotics within the previous 30 days * Wards of the state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary miRNA Profile | At the time of collection (from 18 months to 6 years 11 months of age) | Measures of miRNA abundance in saliva |
| DSM-5 Diagnosis | At the time of the diagnostic evaluation | Confirmation of participants meeting or not meeting the DSM-5 Criteria for a diagnosis of Autism Spectrum Disorder |
Countries
United States
Contacts
Primary ContactAndrew Brindle
Backup ContactArianna Montefusco
Outcome results
None listed