Early Assessment of Autism Through Smart Tablet Gameplay

NCT03438994 | Completed DMC

• 1 other identifier: UEC17/49
• Study Type: interventional
• Target: 779
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary aim of this study is to compare the diagnostic accuracy of an iPad application (Play.Care assessment) with the current clinical "gold standard" diagnosis for diagnosis of Autism Spectrum Disorder (ASD) in children. Recent evidence has suggested that movement abnormalities are one of the early markers of ASD. However, current clinical diagnostic assessments fail to take this into account. Further, the current "gold standard" clinical tests take a number of hours to administer, require extensive clinical training and are subject to a certain level of subjectivity. Alternatively, by assessing a child's interaction with an iPad screen as they play, an objective measurement of movement can be obtained, which can aid in the diagnostic process. This study aims to recruit a total of 760 children (Typically Developing (TD), Other Neurodevelopmental Disorders (OND) and ASD groups) to assess the diagnostic accuracy of tablet game play in ASD. Children who have been diagnosed with ASD will perform the Play.Care assessment to assess if the tablet result matches their clinical diagnosis. Results from the clinical assessment and Play.Care assessment will then be compared to assess the sensitivity (the proportion of participants with ASD who test positive for ASD as a result of the Play.Care assessment) and specificity (the proportion of participants without ASD who test negatively for ASD as a result of the Play.Care assessment assessment) of the Play.Care assessment.

Conditions

Autism Spectrum Disorder; Other Neurodevelopmental Disorder

Keywords

autism; movement; tablet; gameplay

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of Play.Care to detect ASD

  sensitivity and specificity of Play.Care to detect ASD

  Single data collection time point of 15 minutes for each subject.

Secondary Outcomes (1)

• Ability of Play.Care to distinguish ASD from OND

  Single data collection time point of 15 minutes for each subject.

Study Arms (3)

Participants diagnosed with ASD

ACTIVE COMPARATOR

Diagnostic Test: Play.Care

Participants diagnosed with OND

EXPERIMENTAL

Diagnostic Test: Play.Care

Typically developing participants

ACTIVE COMPARATOR

Diagnostic Test: Play.Care

Interventions

Play.Care DIAGNOSTIC_TEST

iPad based game to assess movement as the player interacts with the screen

Participants diagnosed with ASD; Participants diagnosed with OND; Typically developing participants

Eligibility Criteria

• Age: 30 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All participants:
• Aged 30 months - 5 years inclusive
• ASD Participants:
• Diagnosis of autism spectrum disorder on the basis of DSM-V criteria or equivalent ICD-10 framework (F84): childhood autism (F84.0), atypical autism (F84.1), and Asperger's syndrome (F84.5)
• OND participants:
• Other childhood developmental disorders including, but not limited to,
• Attention Deficit Hyperactivity Disorder,
• Developmental Coordination Disorder,
• Intellectual disability,
• Non- verbal disability and
• Communication Disability.
• Sensory and motor impairments will be included

You may not qualify if:

• Typically developing participants:
• Diagnosis or suspicion of
• Neuropathology
• Psychopathology
• Sensory or motor disorder including mild tremors
• ASD participants:
• Uncorrected sensory (visual, hearing) impairments
• Presence of any motor impairments or behavioural impairment that may obstruct testing
• OND participants:
• Sub-clinical or secondary expressions of ASD
• Uncorrected hearing or vision impairments

Sponsors & Collaborators

• University of Strathclyde: lead
• Harimata: collaborator
• University of Glasgow: collaborator
• University of Aberdeen: collaborator
• Göteborg University: collaborator

Study Sites (2)

Gillberg Neuropsychiatry Centre

Gothenburg, 411 19, Sweden

Location

University of Strathclyde

Glasgow, G, United Kingdom

Location

Related Publications (1)

• Millar L, McConnachie A, Minnis H, Wilson P, Thompson L, Anzulewicz A, Sobota K, Rowe P, Gillberg C, Delafield-Butt J. Phase 3 diagnostic evaluation of a smart tablet serious game to identify autism in 760 children 3-5 years old in Sweden and the United Kingdom. BMJ Open. 2019 Jul 16;9(7):e026226. doi: 10.1136/bmjopen-2018-026226.

  PMID: 31315858 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jonathan Delafield-Butt, PhD

  jonathan.delafield-butt@strath.ac.uk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director Laboratory for Innovation in Autism

Model Details: This study will follow the "Standard for Reporting Diagnostic accuracy studies" (STARD) guidelines

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 20, 2018
• Study Start: January 10, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); SE (1)