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Validation of a Salivary miRNA Diagnostic Test for ASD

Andrew Brindle - abrindle@quadrantbiosciences.com

ALL
18 months to 7 years old
This study is NOT accepting healthy volunteers
NCT05418023
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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
OTHER: Salivary Collection, OTHER: Adaptive Assessment, OTHER: Medical and Demographic questionnaire, OTHER: Autism Assessment, OTHER: Intellectual Development Assessment
Autism Spectrum Disorder, Developmental Delay
Autism Spectrum Disorder, ASD, Saliva, Biomarkers
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