Validation of a Salivary miRNA Diagnostic Test for ASD

Quadrant Biosciences

Status: Enrolling

Conditions: Autism Spectrum Disorder; Developmental Delay

Treatments: Other: Autism Assessment; Other: Adaptive Assessment; Other: Salivary Collection; Other: Medical and Demographic questionnaire; Other: Intellectual Development Assessment

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05418023

20214744

Details and patient eligibility

About

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.

Enrollment: 6,604 estimated patients

Sex: All

Ages: 18 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

6,604 participants in 2 patient groups

Autism Spectrum Disorder (ASD)

Treatment:

Other: Adaptive Assessment

Other: Salivary Collection

Other: Intellectual Development Assessment

Other: Autism Assessment

Other: Medical and Demographic questionnaire

Non-ASD

Treatment:

Other: Adaptive Assessment

Other: Salivary Collection

Other: Intellectual Development Assessment

Other: Autism Assessment

Other: Medical and Demographic questionnaire