An observational study in Autism Spectrum Disorder and Developmental Delay, sponsored by State University of New York - Upstate Medical University. Completed at 1 site in United States. Open to participants aged 24 Months to 48 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by State University of New York - Upstate Medical University · Observational
The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.
The central aim of this project is to validate a panel of expressed microRNA (miRNA) in the saliva of children identified at risk for developing ASD by the MCHAT-R. Further, this study aims to assess the value of the current panel as an adjunctive test that may increase specificity of MCHAT-R positive results, or affirm clinical diagnoses alongside the ADOS or other objective assessments.
The primary endpoints of this study are as follows:
Secondary endpoints are the identification of microtranscriptome features whose concentrations correlate with ASD endophenotypes.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 998 is above the median of 102 across 267 observational studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →State University of New York - Upstate Medical University is the lead sponsor of 154 studies on the registry; 17 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study will compare salivary miRNA in children between the ages of 24 months and 48 months of age who are considered at risk for the development of autism spectrum disorder as identified by a score of 3 or greater on the MCHAT-R.
Exclusion Criteria:
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.
Other: Salivary collection · Other: Vineland Adaptive Behavior Scale-III Assessment · Other: Medical history questionaire · Other: Autism Diagnostic Observation Schedule -2nd edition (ADOS-2) · Other: Mullen Scales of Early Learning
Collection of saliva via swab for miRNA processing
Salivary miRNA profile
Measures of miRNA abundance in saliva
Time frame: at the time of collect (from 18m to 6 years of age)
Measures of adaptive function
Vineland Adaptive Behavior Composite Score
Time frame: At time of enrollment (from 18m to 6 years of age)
Measures of early intellectual development
Mullen Scales of Early Learning
Time frame: At time of enrollment (from 18m to 6 years of age)
Measure of autistic behavior
Autism Diagnostic Observation Schedule (ADOS) Composite Score (Autism Group Only)
Time frame: At time of enrollment (from 18m to 6 years of age)
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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State University of New York - Upstate Medical University