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Telehealth Autism Assessment for Adults

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADOS-2 Module 4
Adapted Telehealth ADOS-2 Module 4
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standardized assessment

Telehealth assessment

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 11, 2021
Last Updated
October 24, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04766970
Brief Title
Telehealth Autism Assessment for Adults
Official Title
Telehealth Autism Assessment for Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standardized assessment
Arm Type
Active Comparator
Arm Title
Telehealth assessment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
ADOS-2 Module 4
Intervention Description
Assessment in person using standardized Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4.
Intervention Type
Behavioral
Intervention Name(s)
Adapted Telehealth ADOS-2 Module 4
Intervention Description
Assessment via telehealth/teleconference platform using an adapted ADOS-2, Module 4 assessment protocol.
Primary Outcome Measure Information:
Title
Concurrent validity
Description
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).
Time Frame
Immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brianna Lewis, PhD
Phone
615-936-2074
Email
brianna.j.lewis@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brianna Lewis, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brianna Lewis, PhD
Email
brianna.j.lewis@vumc.org

12. IPD Sharing Statement

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Telehealth Autism Assessment for Adults

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