About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
400 children aged 0 years to 17 years 11 months with a neurological, psychiatric or neurodevelopmental disorder. 250 children in this sample will have a known diagnosis of ASD: 50 children with a diagnosed MD (ASD/MD), 50 children with ruled out MD (ASD/NoMD), 150 children with ASD and unknown MD status. Comparison groups: 50 children with epilepsy (without ASD), 50 with psychiatric disorders, 50 with brain tumors (without ASD) 50 with a diagnosed MD (without ASD) Control group: 100 TD children (50 siblings of children with ASD and 50 without any siblings with ASD or developmental delay).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
9
Trial groupsSee each trial group below.
Trial outcomes
Primary outcomes
Mitochondrial Reserve Capacity measured using the Seahorse XR Flux Analyzer
Children with ASD will be differentiated from all other cohorts and have a specific pattern of mitochondrial dysfunction that will be different from and comparable to other groups of children in the study (e.g. mitochondrial disease without autism, typically developing, autism with mitochondrial disease, and developmental delay). It is hypothesized that these children will have a more pronounced delay in their development and will have a higher probability for poor developmental and behavioral outcomes. This will be evaluated using a Seahorse XR flux analyzer to generate a maximal reserve capacity value.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Southwest Autism Research & Resource Center
Lead sponsor
State University of New York - Downstate Medical Center
Collaborator