Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

November 15, 2022 updated by: Stalicla SA
The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cincinnati Children's Hospital Primary Care Clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: Day 0
A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stalicla SA

Investigators

  • Principal Investigator: Craig A Erickson, MD, CCHMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 4, 2020

Primary Completion (ACTUAL)

October 31, 2022

Study Completion (ACTUAL)

October 31, 2022

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STP1-C003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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