Validation of a Salivary miRNA Diagnostic Test for ASD

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.

Conditions

• Autism Spectrum Disorder
• Developmental Delay

Interventions

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

Sponsors & Collaborators

• University of California, Irvine

  collaborator OTHER

• Holland Bloorview Kids Rehabilitation Hospital

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• MetroHealth Medical Center

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Prisma Health-Upstate

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• State University of New York - Upstate Medical University

  collaborator OTHER

• Rush University

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Drexel University

  collaborator OTHER

• Emory University

  collaborator OTHER

• Quadrant Biosciences Inc.

  lead INDUSTRY

Principal Investigators

• David Levitskiy, MS · Quadrant Biosciences

Eligibility

Min Age

18 Months

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-16

Primary Completion

2023-07-31

Completion

2023-07-31

Countries

• United States

Study Locations