Autism Spectrum DisorderNCT06582290
Investigating the Clinical Utility of the Oxford Virtual Autism Assessment Tool (OVAAT)
A study testing Oxford Virtual Autism Assessment Tool (OVAAT) in people with Autism Spectrum Disorder and Healthy, run by Oxford Health NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Healthy, Neurotypical
- What is being tested?
- Oxford Virtual Autism Assessment Tool (OVAAT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2023to May 2025
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Health NHS Foundation Trust
Oxford, OX3 7JH
Sophie Chalker, +441865 902447, ovaat.study@oxfordhealth.nhs.uk
About this study
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?
Read the detailed description
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
- Autism Spectrum Disorder, Healthy, Neurotypical
- Being tested
- Oxford Virtual Autism Assessment Tool (OVAAT)
- Keywords
- Autism Spectrum Disorder, ASD, OVAAT, Evaluation, Clinical utility
- 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.
Oxford Virtual Autism Assessment Tool (OVAAT)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.
| Study group | Role | What they receive |
|---|---|---|
| Autistic | Experimental | 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. Receives: Diagnostic Test: Oxford Virtual Autism Assessment Tool (OVAAT) |
| Neurotypical | Experimental | 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. Receives: Diagnostic Test: Oxford Virtual Autism Assessment Tool (OVAAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 weeks after recruitment
Secondary outcomes (5)
Revised Children's Anxiety and Depression Scale (and Subscales) (RCADS)
Used in the screening for group 2 47 item questionnaire scored on a scale of 0-3, with 0 being "never" and 3 being "always"). Participants in group 2 will score statements based on how often the things (statements) happen to them e.g., "I worry about things".
Measured: Day 0
Autism Spectrum Quotient (AQ-10)
Used in group 2 screening process. 10 item measure that looks at whether a person should be be referred for further autism assessment. Participants are asked to indicate their level of agreement on 10 statements (on a scale of 1-4, 1 being "definitely agree" to 4 "definitely disagree").
Measured: Day 0
Adult ADHD Self-Report Scale (ASRS)
Used in the group 2 screening process 18-item questionnaire spilt into 2 parts (part a. and part b.). Participants are asked to score rate themselves based on how they have felt and conducted themselves over the past six months (using "never", "rarely", "sometimes", "often" or "very often").
Measured: Day 0
Prodromal Questionnaire (PQ-16)
Used in group 2 screening process. 16-item questionnaire that asks participants to either indicate "true" or "false" for 16 items that look at the risk of potential psychosis. For any statements that participants indicate as "true" they are asked to rate their level of distress (on a scale of 0-3, with 0 being "none" and 3 being "severe").
Measured: Day 0
Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
This used before the OVAAT and is used in the diagnostic assessment in group 1. The ADOS-2 is an observation-based tool used to assess and diagnose ASD. It uses a combination of questions and activities to assess and evaluate a person's communication skills, social interaction and imaginative se of materials.
Measured: Within 2 to 3 months of consent form being signed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start22 Sep 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Health NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582290
- Sponsor's protocol ID
- OxfordNHS
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the participants age and because the IPD may contain identifiable or sensitive information it is unlikely this will be shared outside of the trust.
Publications
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.
PubMed 25569603
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Clinical Utility of the Oxford Virtual Autism Assessment Tool (OVAAT)
- ClinicalTrials.gov ID
- NCT06582290
- Acronym / sponsor ID
- OxfordNHS
- Conditions
- Autism Spectrum Disorder, Healthy, Neurotypical
- Keywords
- Autism Spectrum Disorder, ASD, OVAAT, Evaluation, Clinical utility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oxford Health NHS Foundation TrustOther government
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 3 Sep 2024 (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 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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Autistic | Experimental | Diagnostic Test: Oxford Virtual Autism Assessment Tool (OVAAT)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. |
| Neurotypical | Experimental | Diagnostic Test: Oxford Virtual Autism Assessment Tool (OVAAT)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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| 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. | Diagnostic test | Autistic, Neurotypical |
Primary outcome
Oxford Virtual Autism Assessment Tool (OVAAT)
Time frame: Up to 3 weeks after recruitment
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.
5 secondary outcomes
Revised Children's Anxiety and Depression Scale (and Subscales) (RCADS)
Time frame: Day 0
Autism Spectrum Quotient (AQ-10)
Time frame: Day 0
Adult ADHD Self-Report Scale (ASRS)
Time frame: Day 0
Prodromal Questionnaire (PQ-16)
Time frame: Day 0
Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
Time frame: Within 2 to 3 months of consent form being signed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 25569603Schutte 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.
- Individual participant dataSharing planned: No. Due to the participants age and because the IPD may contain identifiable or sensitive information it is unlikely this will be shared outside of the trust.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxford Virtual Autism Assessment Tool (OVAAT) in people with Autism Spectrum Disorder and Healthy, run by Oxford Health NHS Foundation Trust at 1 site in United Kingdom.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Sep 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Chalker (+441865 902447, ovaat.study@oxfordhealth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Virtual Autism Assessment Tool (OVAAT) (time frame: Up to 3 weeks after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06582290, which also lists 1 linked publication.
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 3 Sep 2024.