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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04766970
Other study ID # 202427
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Vanderbilt University Medical Center
Contact Brianna Lewis, PhD
Phone 615-936-2074
Email brianna.j.lewis@vumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to investigate the reliability and validity of an adapted Autism Spectrum Disorder assessment measure for use in a telehealth visit.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Age 18-60 years old - Access to personal computer with video, microphone, and speaker - English literate - Fluent English speaker Exclusion Criteria: - Non-fluent English speaker - Not English literate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ADOS-2 Module 4
Assessment in person using standardized Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4.
Adapted Telehealth ADOS-2 Module 4
Assessment via telehealth/teleconference platform using an adapted ADOS-2, Module 4 assessment protocol.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concurrent validity Concurrent validity will be assessed through correlations between the domain, Overall Total, and calculated Comparison scores of the two ADOS-2 versions, as well as through comparison of total scores on the Social Communication Questionnaire (SCQ) and the Social Responsiveness Scale, Second Edition (SRS-2). Immediately after intervention
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