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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Months and 7 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Autism Spectrum Disorder (ASD)
  • Other: Salivary Collection
    Collection of saliva via swab for miRNA processing
  • Other: Adaptive Assessment
    Includes Vineland Adaptive Behavior Scale or equivalent
  • Other: Medical and Demographic questionnaire
    Survey that collects basic medical and demographic information
  • Other: Autism 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
  • Other: Intellectual 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
Non-ASD
  • Other: Salivary Collection
    Collection of saliva via swab for miRNA processing
  • Other: Adaptive Assessment
    Includes Vineland Adaptive Behavior Scale or equivalent
  • Other: Medical and Demographic questionnaire
    Survey that collects basic medical and demographic information
  • Other: Autism 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
  • Other: Intellectual 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

Recruiting Locations

MetroHealth Medical Center
Parma, Ohio 44130
Contact:
Melissa Armstrong-Brine, PhD

More Details

Status
Recruiting
Sponsor
Quadrant Biosciences Inc.

Study Contact

Andrew Brindle
3153260760
abrindle@quadrantbiosciences.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.