Study Stopped
No subjects enrolled
Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder
1 other identifier
observational
N/A
1 country
1
Brief Summary
This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedAugust 31, 2022
August 1, 2022
4 months
October 19, 2020
August 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD)
A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants
Day 0
Eligibility Criteria
Nationwide Children's Hospital Primary Care Clinic
You may qualify if:
- Previously diagnosed with ASD (based on DSM-5 criteria and supported by either ADI-R or ADOS-2 scores)
- At least two well documented head circumference values recorded within the first 2 years of life
- Participants must have a parent or reliable caregiver who agrees to provide information about the participant as required by the protocol and should be fluent in English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stalicla SAlead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
November 30, 2020
Primary Completion
March 31, 2021
Study Completion
April 30, 2021
Last Updated
August 31, 2022
Record last verified: 2022-08