Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04600882

Enrollment

Registered

2020-10-23

Start date

2020-11-30

Completion date

2021-04-30

Last updated

2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorder, endophenotyping, observational

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

4 Years to 10 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results