Validation of a Salivary miRNA Diagnostic Test for ASD

Study Overview
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Brief Summary
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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.

Official Title
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Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder, Developmental Delay

Intervention / Treatment
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* Other: Salivary Collection
* Other: Adaptive Assessment
* Other: Medical and Demographic questionnaire
* Other: Autism Assessment
* Other: Intellectual Development Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autism Spectrum Disorder (ASD)<br> | Other: Salivary Collection<br>* Collection of saliva via swab for miRNA processing<br>Other: Adaptive Assessment<br>* Includes Vineland Adaptive Behavior Scale or equivalent<br>Other: Medical and Demographic questionnaire<br>* Survey that collects basic medical and demographic information<br>Other: Autism Assessment<br>* Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent<br>Other: Intellectual Development Assessment<br>* 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<br>|
| Non-ASD<br> | Other: Salivary Collection<br>* Collection of saliva via swab for miRNA processing<br>Other: Adaptive Assessment<br>* Includes Vineland Adaptive Behavior Scale or equivalent<br>Other: Medical and Demographic questionnaire<br>* Survey that collects basic medical and demographic information<br>Other: Autism Assessment<br>* Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent<br>Other: Intellectual Development Assessment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary miRNA Profile | Measures of miRNA abundance in saliva | At the time of collection (from 18 months to 6 years 11 months of age) | 
| DSM-5 Diagnosis | Confirmation of participants meeting or not meeting the DSM-5 Criteria for a diagnosis of Autism Spectrum Disorder | At the time of the diagnostic evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, ASD, Saliva, Biomarkers