Improving Autism Screening With Brain-Related miRNA

Completed

Conditions studied: Autism Spectrum Disorder, Developmental Delay

In brief

The goal of this project is to identify specific miRNAs that are increased or decreased in the saliva of children with developmental delay and are useful for screening toddlers for ASD. Such a screening tool would improve the specificity of diagnosis, streamline referrals to developmental specialists, and expedite the arrangement of early intervention services.

Key facts

Study ID

NCT02712853

Run by

Milton S. Hershey Medical Center

People needed

304

Starts

2015-11-01

Expected to finish

2018-08-01

Last updated by the study team

2018-08-22

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • Age at enrollment: 18 months and 6 years (inclusive)
• Control group documented negative ASD screening on M-CHAT-R
• ASD group: established DSM-5 diagnosis
• Parent/guardian must be fluent in written and spoken English (required to complete study specific questionnaires etc)

You may not qualify if…

• For autistic subjects study exclusion criteria will include:
• Autistic subjects with known syndromic autism (attributed to a known genetic mutation)
• Control subjects only exclusion criteria will include:
• A diagnosis of autism
• For both groups: wards of the state, active periodontal infection, active upper respiratory infection

Where it is running

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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