Summary

Eligibility
for people ages 18 months to 7 years (full criteria)
Location
at Santa Ana, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder Developmental Delay ASD Saliva Biomarkers Autistic Disorder Child Development Disorders, Pervasive Salivary Collection Adaptive Assessment Autism Assessment Intellectual Development Assessment Autism Spectrum Disorder (ASD)

Eligibility

You can join if…

Open to people ages 18 months to 7 years

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California - Irvine accepting new patients
    Santa Ana California 92705 United States
  • Children's Hospital Los Angeles not yet accepting patients
    Los Angeles California 90027 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Quadrant Biosciences Inc.
ID
NCT05418023
Study Type
Observational
Participants
Expecting 6604 study participants
Last Updated