Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder (ASD)

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.

Study Overview

• Status: Withdrawn
• Conditions: Autism Spectrum Disorder

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Nationwide Children's Hospital Primary Care Clinic

Description

Inclusion Criteria:

• 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

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stalicla SA

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: autism spectrum disorder; observational; endophenotyping
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: STP1-C002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No