Autism Spectrum DisorderNCT04766970
Telehealth Autism Assessment for Adults
A study testing ADOS-2 Module 4 and Adapted Telehealth ADOS-2 Module 4 in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ADOS-2 Module 4 and Adapted Telehealth ADOS-2 Module 4
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 22 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years old
- Access to personal computer with video, microphone, and speaker
- English literate
- Fluent English speaker
Who cannot join
- Non-fluent English speaker
- Not English literate
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
The study aims to investigate the reliability and validity of an adapted Autism Spectrum Disorder assessment measure for use in a telehealth visit.
- Conditions
- Autism Spectrum Disorder
- Being tested
- ADOS-2 Module 4, Adapted Telehealth ADOS-2 Module 4
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADOS-2 Module 4Behavioural
Assessment in person using standardized Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4.
Adapted Telehealth ADOS-2 Module 4Behavioural
Assessment via telehealth/teleconference platform using an adapted ADOS-2, Module 4 assessment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Standardized assessment | Active comparator | Not described Receives: Behavioral: ADOS-2 Module 4 |
| Telehealth assessment | Experimental | Not described Receives: Behavioral: Adapted Telehealth ADOS-2 Module 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Oct 2022
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Why it stopped: PI resigning from VUMC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brianna Lewis, Vanderbilt University Medical Center
- Investigators
- Brianna Lewis, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766970
- Sponsor's protocol ID
- 202427
- Status last verified
- Aug 2024
- First submitted
- 11 Feb 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Autism Assessment for Adults
- ClinicalTrials.gov ID
- NCT04766970
- Acronym / sponsor ID
- 202427
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI resigning from VUMC
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the reliability and validity of an adapted Autism Spectrum Disorder assessment measure for use in a telehealth visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized assessment | Active comparator | Behavioral: ADOS-2 Module 4 |
| Telehealth assessment | Experimental | Behavioral: Adapted Telehealth ADOS-2 Module 4 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years old
- Access to personal computer with video, microphone, and speaker
- English literate
- Fluent English speaker
Key exclusion criteria (2 listed)
- Non-fluent English speaker
- Not English literate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADOS-2 Module 4Assessment in person using standardized Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4. | Behavioural | Standardized assessment |
| Adapted Telehealth ADOS-2 Module 4Assessment via telehealth/teleconference platform using an adapted ADOS-2, Module 4 assessment protocol. | Behavioural | Telehealth assessment |
Primary outcome
Concurrent validity
Time frame: 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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brianna Lewis, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADOS-2 Module 4 and Adapted Telehealth ADOS-2 Module 4 in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concurrent validity (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.