Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
6604 participants
OBSERVATIONAL
2022-03-16
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Autism Spectrum Disorder (ASD)
Salivary Collection
Collection of saliva via swab for miRNA processing
Adaptive Assessment
Includes Vineland Adaptive Behavior Scale or equivalent
Medical and Demographic questionnaire
Survey that collects basic medical and demographic information
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
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
Salivary Collection
Collection of saliva via swab for miRNA processing
Adaptive Assessment
Includes Vineland Adaptive Behavior Scale or equivalent
Medical and Demographic questionnaire
Survey that collects basic medical and demographic information
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
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
Interventions
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Salivary Collection
Collection of saliva via swab for miRNA processing
Adaptive Assessment
Includes Vineland Adaptive Behavior Scale or equivalent
Medical and Demographic questionnaire
Survey that collects basic medical and demographic information
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Months
7 Years
ALL
No
Sponsors
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University of California, Irvine
OTHER
Holland Bloorview Kids Rehabilitation Hospital
OTHER
Children's Hospital of Philadelphia
OTHER
MetroHealth Medical Center
OTHER
University of Rochester
OTHER
Nationwide Children's Hospital
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
University of Pittsburgh
OTHER
University of Massachusetts, Worcester
OTHER
Children's Hospital Los Angeles
OTHER
Prisma Health-Upstate
OTHER
University of Virginia
OTHER
State University of New York - Upstate Medical University
OTHER
Rush University
OTHER
Seattle Children's Hospital
OTHER
Drexel University
OTHER
Emory University
OTHER
Quadrant Biosciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Levitskiy, MS
Role: PRINCIPAL_INVESTIGATOR
Quadrant Biosciences
Locations
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University of California - Irvine
Santa Ana, California, United States
Marcus Autism Center/Emory University
Atlanta, Georgia, United States
RUSH University
Chicago, Illinois, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
University of Rochester
Rochester, New York, United States
Quadrant Biosciences
Syracuse, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
MetroHealth Medical Center
Parma, Ohio, United States
Nationwide Children's Hospital
Westerville, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Drexel University
Philadelphia, Pennsylvania, United States
Prisma Health-Upstate
Greenville, South Carolina, United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Jean Gehricke, PhD
Role: primary
Cheryl Klaiman, PhD
Role: primary
Latha Soorya, PhD
Role: primary
Jean Frazier, MD
Role: primary
Lynn Cole, MS
Role: primary
Henry Roane, PhD
Role: primary
Rebecca Shaffer, PsyD
Role: primary
Melissa Armstrong-Brine, PhD
Role: primary
Eric Butter, PhD
Role: primary
Amanda Bennett, MD
Role: primary
Diana Robins, PhD
Role: primary
Karen Ratliff-Schaub, MD
Role: primary
Robin Kochel, PhD
Role: primary
Richard Stevenson, MD
Role: primary
Karen Bearss, PhD
Role: primary
References
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Hicks SD, Ignacio C, Gentile K, Middleton FA. Salivary miRNA profiles identify children with autism spectrum disorder, correlate with adaptive behavior, and implicate ASD candidate genes involved in neurodevelopment. BMC Pediatr. 2016 Apr 22;16:52. doi: 10.1186/s12887-016-0586-x.
Hicks SD, Rajan AT, Wagner KE, Barns S, Carpenter RL, Middleton FA. Validation of a Salivary RNA Test for Childhood Autism Spectrum Disorder. Front Genet. 2018 Nov 9;9:534. doi: 10.3389/fgene.2018.00534. eCollection 2018.
Hicks SD, Carpenter RL, Wagner KE, Pauley R, Barros M, Tierney-Aves C, Barns S, Greene CD, Middleton FA. Saliva MicroRNA Differentiates Children With Autism From Peers With Typical and Atypical Development. J Am Acad Child Adolesc Psychiatry. 2020 Feb;59(2):296-308. doi: 10.1016/j.jaac.2019.03.017. Epub 2019 Mar 27.
Other Identifiers
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20214744
Identifier Type: -
Identifier Source: org_study_id
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