NCT04766970

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

February 11, 2021

Last Update Submit

August 22, 2024

Conditions

Autism Spectrum Disorder

Outcome Measures

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).

    Immediately after intervention

Study Arms (2)

Standardized assessment

ACTIVE COMPARATOR
Behavioral: ADOS-2 Module 4

Telehealth assessment

EXPERIMENTAL
Behavioral: Adapted Telehealth ADOS-2 Module 4

Interventions

ADOS-2 Module 4BEHAVIORAL

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

Standardized assessment
Adapted Telehealth ADOS-2 Module 4BEHAVIORAL

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

Telehealth assessment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years old
  • Access to personal computer with video, microphone, and speaker
  • English literate
  • Fluent English speaker

You may not qualify if:

  • Non-fluent English speaker
  • Not English literate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Brianna Lewis, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 23, 2021

Study Start

October 1, 2022

Primary Completion

August 22, 2024

Study Completion

August 22, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations

US(1)