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Trial registered on ANZCTR


Registration number
ACTRN12619000317190
Ethics application status
Approved
Date submitted
18/02/2019
Date registered
1/03/2019
Date last updated
29/03/2019
Date data sharing statement initially provided
1/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Could "Gazefinder" Eye-Tracking Technology Support the Earlier Identification and Diagnosis of Autism in Young Children?
Scientific title
Clinical Trial examining the sensitivity and specificity of Gazefinder for identifying young children with autism
Secondary ID [1] 297300 0
None
Universal Trial Number (UTN)
U1111-1228-0150
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 311385 0
Condition category
Condition code
Mental Health 310021 310021 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 313552 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator is a sample of typically-developing (TD) children, of the same mean and range of ages as the group of children with autism, in whom we can be confident there are no developmental concerns or behavioural signs of autism (i.e., ascertained via exclusion criteria and information provided on parent-report questionnaires).
Control group
Active

Outcomes
Primary outcome [1] 318926 0
Gaze pattern to more vs. less socially salient 'regions of interest' (ROIs) within 'Scene 10' stimulus sequence as assessed using Gazefinder eye-tracker
Timepoint [1] 318926 0
Single timepoint observational study only.
Secondary outcome [1] 366441 0
Exploratory analysis - as a function of within-group variability - of child gaze patterns to more vs. less socially salient 'regions of interest' (ROIs) within 'Scene 10' stimulus sequence as assessed using Gazefinder eye-tracker
Timepoint [1] 366441 0
Single timepoint observational study only.

Eligibility
Key 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
Minimum age
24 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
In total, 200 children will be enrolled in this trial: 100 with autism and 100 typically developing (TD) children.

The ‘accuracy’ of Gazefinder to differentiate autism from TD will be operationalised as the ‘Area Under the Curve’ (AUC) in the analysis of Receiver Operating Characteristics (ROC), which also provides sensitivity and specificity thresholds for correct classification. An AUC result =.80 may be considered to represent ‘good’ accuracy, and =.90, ‘excellent’ accuracy.

A sample of 40 children gives 95% power for a test of AUC =.80, assuming the following: a = .05, equal number of participants in each group, and a null hypothesis that accuracy is at chance (i.e., AUC = .50). Hence, with a target sample of 200 children – 100 per group – this trial is well-powered to meet its primary objective. Moreover, a sample of 200 gives >95% power for a test that accuracy is ‘excellent’ (i.e., AUC = .90) – again assuming the adoption of a = .05 and equal number of participants in each group – and against the null hypothesis that accuracy is ‘good’ (i.e., AUC = .80).

Furthermore, enrolling a large sample of 100 children with autism will ensure variability in key characteristics (e.g., range of ages, symptom severity and cognitive/developmental ability, etc.) is likely to be captured in the sample, to permit secondary exploratory evaluation of whether there may be individuals/subgroups of participants for whom the accuracy of Gazefinder to differentiate Autism vs. TD may be better/poorer than the observe average estimate of accuracy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2019
Actual
8/03/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 301862 0
Commercial sector/Industry
Name [1] 301862 0
JVCKENWOOD Corporation
Country [1] 301862 0
Japan
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive,
Bundoora, VIC 3086
Country
Australia
Secondary sponsor category [1] 301609 0
None
Name [1] 301609 0
Address [1] 301609 0
Country [1] 301609 0
Other collaborator category [1] 280521 0
Other Collaborative groups
Name [1] 280521 0
Telethon Kids Institute
Address [1] 280521 0
100 Roberts Road
Subiaco, Western Australia, 6008
Country [1] 280521 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302556 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 302556 0
Ethics committee country [1] 302556 0
Australia
Date submitted for ethics approval [1] 302556 0
22/01/2019
Approval date [1] 302556 0
25/02/2019
Ethics approval number [1] 302556 0
LTU HEC19027

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90638 0
Dr Kristelle Hudry
Address 90638 0
La Trobe University
Bundoora VIC 3086
Country 90638 0
Australia
Phone 90638 0
+61394795649
Fax 90638 0
Email 90638 0
[email protected]
Contact person for public queries
Name 90639 0
Kristelle Hudry
Address 90639 0
La Trobe University
Bundoora VIC 3086
Country 90639 0
Australia
Phone 90639 0
+61394795649
Fax 90639 0
Email 90639 0
[email protected]
Contact person for scientific queries
Name 90640 0
Kristelle Hudry
Address 90640 0
La Trobe University
Bundoora VIC 3086
Country 90640 0
Australia
Phone 90640 0
+61394795649
Fax 90640 0
Email 90640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
From publication of the primary trial outcome and for at least 15 years thereafter
Available to whom?
The Chief Investigators will retain a de-identified copy of the dataset for possible future use, and provide a copy of this dataset to the funder (JKC) and third party (PwC) for the conduct of further (independent) analysis and preparation of the Dossier for submission to the Therapeutic Goods Administration (TGA).
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access will be subject to approvals by the Chief Investigators and/or funder (JKC)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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