None listed
Conditions
Brief summary
This is a clinical trial of the accuracy of “Gazefinder” eye-tracking technology to support the identification and diagnosis of autism in young children aged 2- to 4-years, funded by JVCKENWOOD Corporation, Japan (developers and manufacturers of “Gazefinder”) and run by researchers at two Australian sites (Melbourne, Perth). Children in two groups – those with a diagnosis of autism and those with no developmental difficulties or close family members with autism – will view the 2½-minute animation, with preferential attention to more vs. less ‘social’ Regions of Interest (ROIs) automatically determined by Gazefinder software. The hypothesis is that “Gazefinder” will accurately differentiate children with and without autism on the basis of gaze patterns whilst watching the animation sequence.
Interventions
This is an observational trial conducted at a single time-point with planned comparison of participants recruited into two pre-defined groups: (i) children with a community diagnosis of autism, and (ii) children who are typically developing. All children will complete a face-to-face assessment including the Gazefinder eye-tracking assessment that is the focus of this observational trial. One 'Gazefinder gaze tracking and diagnostic system’ device is in use at each site. These have been manufactured by JVCKENWOOD Corporation, Japan, in Feb 2019 – both sites Model GP-100EA, Serial # CTS2-00005 (Telethon Kids Institute site device) and CTS2-00006 (La Trobe University site device). The Gazefinder system is a computer screen, with an integrated infra-red light and camera, which participants view. Stimulus presentation software comprises an initial 5-point calibration sequence followed by ~2.5 minute stimulus presentation (including social/non-social preferential attention, static/moving human face, biological motion and joint attention probes) with pre-specified gaze Regions of Interest (ROIs), known as 'Scene 10'. Each child is seated comfortably to watch Scene 10 presentation on the Gazefinder screen. The initial calibration ensures correct viewing distance and that the infra-red system can identify and track the child’s gaze. Successful calibration is automatically followed by 'Scene 10' presentation, with gaze to ROIs automatically calculated by in-built software. Participant gaze data is downloadable by the operator (as a .csv file) for collation with other data prior for further analysis. Further, children’s parents will complete standardised questionnaire measures and children (with autism only) will complete standard clinical assessments to characterise their symptoms/skills so as to allow confirmation of the appropriateness of their community autism diagnosis and appraise sample heterogeneity. Data will be collected prospectively with the following exceptions (applicable to children with autism only). Parents will be asked to provide evidence of their child’s autism diagnosis given by a community professional (i.e., copy of existing diagnostic report/letter). Further, where a child has recently completed the clinical assessments of autism symptoms (within 4 months) and/or developmental skills (within 1 month) planned for this study, and it is possible to obtain copies of the assessment raw data, these retrospective data will be used to avoid unnecessary reassessment of the child.
Sponsors
Eligibility
Inclusion criteria
Children with autism: Aged between 2 years 0 months and 4 years 11 months, with diagnosis of autism from a community professional (evidenced through provision of copy of report/letter). Typically Developing (TD) children: Aged between 2 years 0 months and 4 years 11 months
Exclusion criteria
Children with autism: Uncorrected visual/hearing impairment Typically developing (TD) children: Uncorrected visual/hearing; parent-reported family history of autism among first-degree relatives (parent/s and/or sibling/s); presence of another developmental condition and/or moderate-level autism behaviours (operationalised as score >12 on Social Communication Questionnaire).