Characterization of a Clinical Subpopulation With Autism Spectrum Disorder
Completed
- Conditions
- Autism Spectrum Disorder
- Registration Number
- NCT04273087
- Lead Sponsor
- Stalicla SA
- Brief Summary
The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
Inclusion Criteria
- Participants previously diagnosed with ASD (DSM-5) supported by either autism diagnostic interview revised (ADI-R) or Autism Diagnostic Observation Scale (ADOS-2) scores
- Available health records within the first 2 years of life
- Participants must have a parent or reliable caregiver who agrees to provide information about the participant
Exclusion Criteria
- Genetically identified ASD (syndromic form of autism, e.g. fragile X)
- Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD) Day 0 A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States