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WithdrawnNCT04766970Updated Aug 23, 2024

Telehealth Autism Assessment for Adults

An interventional study of ADOS-2 Module 4 and Adapted Telehealth ADOS-2 Module 4 in Autism Spectrum Disorder, sponsored by Vanderbilt University Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
PI resigning from VUMC
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Autism Spectrum Disorder
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

Browse Autistic Disorder studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • Non-fluent English speaker
  • Not English literate
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Standardized assessment

    Behavioral: ADOS-2 Module 4

  • Experimental
    Telehealth assessment

    Behavioral: Adapted Telehealth ADOS-2 Module 4

Interventions

  • BehavioralADOS-2 Module 4

    Assessment in person using standardized Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4.

  • BehavioralAdapted Telehealth ADOS-2 Module 4

    Assessment via telehealth/teleconference platform using an adapted ADOS-2, Module 4 assessment protocol.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Immediately after intervention

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04766970
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Brianna Lewis (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Feb 23, 2021
Start date
Oct 1, 2022
Primary completion
Aug 22, 2024
Completion
Aug 22, 2024
Last update
Aug 23, 2024

Study contacts

Brianna Lewis, PhD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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