NCT04273087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 4, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

February 6, 2020

Last Update Submit

November 15, 2022

Conditions

Autism Spectrum Disorder

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

Interventions

ObservationOTHER

Clinical signs and symptoms

Eligibility Criteria

Age10 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cincinnati Children's Hospital Primary Care Clinic

You may qualify if:

  • 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

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

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Observation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Craig A Erickson, MD

    CCHMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 17, 2020

Study Start

June 4, 2020

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

November 18, 2022

Record last verified: 2022-11

Locations

US(1)