Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582290
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Investigating the Clinical Utility of the Oxford Virtual Autism Assessment Tool OVAAT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Clinical Utility of the Oxford Virtual Autism Assessment Tool OVAAT
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 evidence-based observational tool ADOS-2 in identifying features of autism
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 ie tools that have been formally researchedevaluated 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 featuressymptoms of ASD but describe internal featuressymptoms of ASD At present there is a no standardised virtualonline 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 andor their parents will be given information about how to access further support
It is possible that participants confidentiality might need to be broken eg 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 eg 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 ie those who can mitigate the risk and prevent harm will be informed eg GP emergency services CAMHS professionals parentscaregivers and they will only be provided with information relevant to the risk Participants and their parentscaregivers where appropriate will be informed of what information has been shared and with whom
Standardised tools ie tools that have been formally researchedevaluated 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 featuressymptoms of ASD but describe internal featuressymptoms of ASD At present there is a no standardised virtualonline 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 andor their parents will be given information about how to access further support
It is possible that participants confidentiality might need to be broken eg 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 eg 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 ie those who can mitigate the risk and prevent harm will be informed eg GP emergency services CAMHS professionals parentscaregivers and they will only be provided with information relevant to the risk Participants and their parentscaregivers where appropriate will be informed of what information has been shared and with whom
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None