Telehealth Autism Assessment for Adults
Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04766970
Collaborator
(none)
100
2
43
Study Details
Study Description
Brief Summary
The study aims to investigate the reliability and validity of an adapted Autism Spectrum Disorder assessment measure for use in a telehealth visit.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Telehealth Autism Assessment for Adults
Anticipated Study Start Date
:
Jun 1, 2022
Anticipated Primary Completion Date
:
Dec 31, 2025
Anticipated Study Completion Date
:
Dec 31, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standardized assessment
|
Behavioral: ADOS-2 Module 4
Assessment in person using standardized Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4.
|
| Experimental: Telehealth assessment
|
Behavioral: Adapted Telehealth ADOS-2 Module 4
Assessment via telehealth/teleconference platform using an adapted ADOS-2, Module 4 assessment protocol.
|
Outcome Measures
Primary Outcome Measures
- Concurrent validity [Immediately after intervention]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Brianna Lewis,
Assistant Professor,
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT04766970
Other Study ID Numbers:
- 202427
First Posted:
Feb 23, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: