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RecruitingNCT04322734

Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders

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Trial Parameters

ConditionAutism Spectrum Disorder
SponsorSouthwest Autism Research & Resource Center
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment500
SexALL
Min AgeN/A
Max Age18 Years
Start Date2023-12-13
Completion2028-12-31

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Brief Summary

The study involves up to 5 visits for a fasting blood draw, behavioral assessments, and/or questionnaires. Other samples may be collected when appropriate. This study is currently recruiting. There is no cost for visits or study-related exams.

Eligibility Criteria

Inclusion Criteria (ASD): 1. ASD, as defined by either a gold standard measure for ASD diagnosis, the Autism Diagnostic Observation Schedule (ADOS); the Autism Diagnostic Interview-Revised (ADI-R); and/or a comprehensive assessment that is consistent with ASD, in the opinion of the principal investigator. For those the PI believes a prospective diagnosis of ASD is warranted, a formal diagnostic assessment will be scheduled at screening. 2. 0 years through 17 years 11 months of age Inclusion Criteria (TD, MD, Epilepsy, Brain Tumor, Psychiatric) 1\. 0 years to 17 years 11 months of age Exclusion Criteria (All): 1. History of a significant adverse reaction to a prior blood draw 2. In females of reproductive age, pregnancy or plans to become pregnant 3. Any other historical event/information that may, in the opinion of the PI, be a reason to exclude the child from participation.

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