Early Assessment of Autism Through Smart Tablet Gameplay

NCT03438994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 779

Last updated 2026-04-17

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Play.Care

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

Sponsors & Collaborators

  • Harimata

    collaborator UNKNOWN
  • University of Glasgow

    collaborator OTHER
  • University of Aberdeen

    collaborator OTHER
  • Göteborg University

    collaborator OTHER
  • University of Strathclyde

    lead OTHER

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2019-07-30
Completion
2019-07-30

Countries

  • Sweden
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438994 on ClinicalTrials.gov