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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COMPLETED
998 participants
OBSERVATIONAL
2015-11-01
2021-08-31
Brief Summary
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Detailed Description
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The primary endpoints of this study are as follows:
1. Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with ASD from their non-ASD peers.
2. Assess stability of the salivary microtranscriptome diagnosis over time, and interrogate longitudinal microtranscriptome levels relative to neuropsychological measures.
Secondary endpoints are the identification of microtranscriptome features whose concentrations correlate with ASD endophenotypes.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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MCHAT-R Positive
Children identified at risk for the development of autism spectrum disorder (ASD) by scoring a 3 or higher on the MCHAT-R. Participants should not have a history of extreme pre-term birth or underlying neurological disorders such as seizures or cerebral palsy.
Salivary collection
Collection of saliva via swab for miRNA processing
Vineland Adaptive Behavior Scale-III Assessment
Medical history questionaire
Autism Diagnostic Observation Schedule -2nd edition (ADOS-2)
Mullen Scales of Early Learning
Interventions
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Salivary collection
Collection of saliva via swab for miRNA processing
Vineland Adaptive Behavior Scale-III Assessment
Medical history questionaire
Autism Diagnostic Observation Schedule -2nd edition (ADOS-2)
Mullen Scales of Early Learning
Eligibility Criteria
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Inclusion Criteria
* MCHAT-R score of 3 or greater
* Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc)
Exclusion Criteria
* history of extreme pre-term birth (\< 32 weeks gestation)
* wards of the state
* Autistic subjects with known syndromic autism (attributed to a known genetic mutation)
24 Months
48 Months
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Quadrant Biosciences Inc.
INDUSTRY
Milton S. Hershey Medical Center
OTHER
University of Missouri-Columbia
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Baylor College of Medicine
OTHER
State University of New York - Upstate Medical University
OTHER
Responsible Party
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Frank A Middleton
Principal Investigator/Associate Professor
Locations
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SUNY Upstate Medical University
Syracuse, New York, United States
Countries
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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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