Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
Recruiting · NCT04322734 · Observational (researchers observe without assigning treatment) · Lead sponsor: Southwest Autism Research & Resource Center
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
Up to 18 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- ASD):
- 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.
- 0 years through 17 years 11 months of age
- Inclusion Criteria (TD, MD, Epilepsy, Brain Tumor, Psychiatric)
- \. 0 years to 17 years 11 months of age
Exclusion criteria
- All):
- History of a significant adverse reaction to a prior blood draw
- In females of reproductive age, pregnancy or plans to become pregnant
- Any other historical event/information that may, in the opinion of the PI, be a reason to exclude the child from participation.
Where it is running
2 locations listed across 2 US states.
- Southwestern Research and Resource Center - Phoenix, Arizona, United States
- State University of New York, Downstate - Brooklyn, New York, United States