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

NCT06582290 | Recruiting

• 1 other identifier: OxfordNHS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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?

Conditions

Autism Spectrum Disorder; Healthy; Neurotypical

Keywords

Autism Spectrum Disorder; ASD; OVAAT; Evaluation; Clinical utility

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 weeks after recruitment

Secondary Outcomes (5)

• Revised Children's Anxiety and Depression Scale (and Subscales) (RCADS)

  Day 0

• Autism Spectrum Quotient (AQ-10)

  Day 0

• Adult ADHD Self-Report Scale (ASRS)

  Day 0

• Prodromal Questionnaire (PQ-16)

  Day 0

• Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)

  Within 2 to 3 months of consent form being signed

Study Arms (2)

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.

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.

Diagnostic Test: Oxford Virtual Autism Assessment Tool (OVAAT)

Interventions

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.

Autistic; Neurotypical

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford Health NHS Foundation Trust: lead

Study Sites (1)

Oxford Health NHS Foundation Trust

Oxford, OX3 7JH, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 25569603 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Sophie Chalker

CONTACT

+441865 902447; ovaat.study@oxfordhealth.nhs.uk

James Stacey

CONTACT

+441865 902447; ovaat.study@oxfordhealth.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The two clinicians completing and coding the OVAATs will be blind to which group the participant is.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 3, 2024
• Study Start: September 22, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)