Investigating the Clinical Utility of the Oxford Virtual Autism Assessment Tool (OVAAT)

NCT ID: NCT06582290

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of the study is to evaluate a new Autism Spectrum Disorder (ASD) diagnostic tool (Oxford Virtual Autism Assessment Tool (OVAAT)) to see whether it can:

* Be able to identify autistic traits
* Be able to distinguish between autistic and non-autistic young people
* Is the tool better, similar or worse than another evidence-based observational tool (ADOS-2) in identifying features of autism?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background and study aims:

Standardised tools (i.e. tools that have been formally researched/evaluated) are a key part of ASD assessments. Some young people prefer online to face-to-face assessments. Recent research indicates that some young people with ASD show fewer observable features/symptoms of ASD but describe internal features/symptoms of ASD. At present, there is (a) no standardised virtual/online assessment tool and (b) no standardised tool which balances gathering information about observable features of ASD and self-reported features of ASD. This study will begin the process of scientifically evaluating the OVAAT (a video-based tool assessing both observable and self-reported features of ASD).

Who can participate? The study will have two groups: group 1 will be 13-18 year old young people waiting for an autism assessment in the Oxfordshire CAMHS Neurodevelopmental Conditions (NDC) pathway who have access to and are able to use a laptop or desktop computer and a quiet place to complete the assessment. Group 2 will be 13-18 year old young people with no neurodevelopmental or mental health conditions who have access to and are able to use a laptop or desktop computer and a quiet place to complete the assessment.

What does the study involve? Group 1: Participants will complete the OVAAT and an ADOS-2 assessment. The OVAAT is the tool that is being tested. The ADOS-2 is an existing tool that is used to assess autism and participants would complete this as part of the standard assessment. The OVAAT assessment will be video and audio recorded (through Microsoft Teams) so that the investigators can check whether another clinical researcher comes to the same conclusion as the person providing the OVAAT. The investigators will only keep the recording until the second researcher has watched and listened to the recording.

Group 2: Participants will complete some questionnaires that identify potential features of autism, ADHD and common mental health problems. Participants will also meet with a clinical researcher from the NDC team to complete the OVAAT. The OVAAT assessment will be video and audio recorded (through Microsoft Teams) so that the investigators can check whether another clinical researcher comes to the same conclusion as the person providing the OVAAT. The recordings will only be kept until the second researcher has watched and listened to the recording.

What are the possible benefits of participating? Participants will be given a £10 Amazon voucher for taking part (for group 2, participants will need to complete the screening measures (participants must pass the screening) and the OVAAT before receiving the voucher. For group 1, participants will need to complete the diagnostic assessment and the OVAAT before receiving the voucher). The investigators also hope that this study will help to determine whether this new tool (the OVAAT) is better than existing tools at identifying autism and give young people a better experience during their assessment.

What are the possible risks of participating? There are no significant risks to taking part. However, the questionnaires or OVAAT could identify potential neurodevelopmental features or symptoms of mental health problems. If this happens, participants and/or their parents will be given information about how to access further support.

It is possible that participants confidentiality might need to be broken (e.g. if there is a risk of significant harm to the participant or others). If this is the case, every effort will be made to discuss this with the participant (unless this would e.g. increase the risk of harm). If there is a significant risk of harm to the participant or someone else, only people who need to be informed of the risk (i.e. those who can mitigate the risk and prevent harm) will be informed (e.g. GP, emergency services, CAMHS professionals, parents/caregivers) and they will only be provided with information relevant to the risk. Participants (and their parents/caregivers, where appropriate) will be informed of what information has been shared, and with whom.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder Healthy Neurotypical

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

The study will use a correlational design. An online autism assessment tool (the Oxford Virtual Autism Assessment Tool (OVAAT)) will be (a) compared to an existing standardised autism observation tool (the ADOS-2) and developmental history (gathered from parents) in terms of it's ability to identify features of ASD and (b) evaluated to determine whether it can distinguish between 13-18 year old young people with ASD and 13-18 year old young people with no neurodevelopmental conditions or mental health problems.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
The two clinicians completing and coding the OVAATs will be blind to which group the participant is.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Autistic

This will be participants who are waiting for an autism assessment in the Oxfordshire CAMHS Neurodevelopmental Conditions (NDC) pathway. The participant are will complete the OVAAT and an ADOS-2 assessment.

The participant will have a neurodevelopmental assessment using the ADOS-2 is an existing tool that we use to assess autism and a developmental history - this is the current standard assessment process. They will receive feedback from this appointment. The second appointment will be using the OVAAT. This assessment will be video and audio recorded (through Microsoft Teams) so that we can check whether another clinical researcher comes to the same conclusion as the person providing the OVAAT. We will only keep the recording until the 2nd researcher has watched and listened to the recording.

Group Type EXPERIMENTAL

Oxford Virtual Autism Assessment Tool (OVAAT)

Intervention Type DIAGNOSTIC_TEST

The OVAAT is an online ASD diagnostic tool that has been designed to identify both the external/observable features of autism but also the internal/experiential features of autism.

Neurotypical

These participants will be neurotypical young people recruited from the general population of Oxfordshire. They will only receive an OVAAT appointment.

The participants will first complete screening measures to assess their eligibility for the study. If they are still eligible, an OVAAT appointment will be arranged. This will be the same process as group 1. This assessment will be video and audio recorded (through Microsoft Teams) so that we can check whether another clinical researcher comes to the same conclusion as the person providing the OVAAT. We will only keep the recording until the 2nd researcher has watched and listened to the recording.

Group Type EXPERIMENTAL

Oxford Virtual Autism Assessment Tool (OVAAT)

Intervention Type DIAGNOSTIC_TEST

The OVAAT is an online ASD diagnostic tool that has been designed to identify both the external/observable features of autism but also the internal/experiential features of autism.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxford Virtual Autism Assessment Tool (OVAAT)

The OVAAT is an online ASD diagnostic tool that has been designed to identify both the external/observable features of autism but also the internal/experiential features of autism.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Group 1: 13-18 year old young people waiting for an autism assessment in the Oxfordshire CAMHS Neurodevelopmental Conditions (NDC) pathway who have access to and are able to use a laptop or desktop computer and a quiet place to complete the assessment.
* Group 2: 13-18 year old young people with no neurodevelopmental or mental health conditions who have access to and are able to use a laptop or desktop computer and a quiet place to complete the assessment.

Exclusion Criteria

* Group 1: 13-18 year old young people waiting for an autism assessment in the Oxfordshire CAMHS NDC pathway who have an existing or suspected neurodevelopmental diagnosis other than autism (e.g. ADHD, Learning Disability) or significant mental health problem (e.g. major depression, psychosis, eating disorder) and/or who are unable to speak English fluently.
* Group 2: 13-18 year olds with any suspected or current neurodevelopmental or mental health conditions and/or who are unable to speak English fluently.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oxford Health NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oxford Health NHS Foundation Trust

Oxford, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sophie Chalker

Role: CONTACT

+441865 902447

James Stacey

Role: CONTACT

+441865 902447

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sophie Chalker

Role: primary

+441865 902447

References

Explore related publications, articles, or registry entries linked to this study.

Schutte JL, McCue MP, Parmanto B, McGonigle J, Handen B, Lewis A, Pulantara IW, Saptono A. Usability and reliability of a remotely administered adult autism assessment, the autism diagnostic observation schedule (ADOS) module 4. Telemed J E Health. 2015 Mar;21(3):176-84. doi: 10.1089/tmj.2014.0011. Epub 2015 Jan 8.

Reference Type BACKGROUND
PMID: 25569603 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OxfordNHS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Opt-In Early Pilot Study
NCT06908187 NOT_YET_RECRUITING NA