Clinical trial NCT03438994: Early Assessment of Autism Through Smart Tablet Gameplay
Official title: Toward Early Autism Assessment: A Prospective Diagnostic Accuracy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Other Neurodevelopmental Disorder
Keywords: autism
movement
tablet
gameplay
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
Collaborators: name: Harimata
name: University of Glasgow
name: University of Aberdeen
name: Göteborg University
First posted: 2018-02-20
Enrollment: 760
Sex: ALL
Minimum age (years): 30
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will follow the "Standard for Reporting Diagnostic accuracy studies" (STARD) guidelines
Primary purpose: DIAGNOSTIC

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.

Detailed description: Autism Spectrum Disorder (ASD) has, historically, been described as primarily a socio-cognitive disorder. While it has been noted that individuals with ASD may exhibit movement abnormalities such as altered gait or increased clumsiness, recent evidence has suggested the possible presence of an underlying motor disruption, common to individuals with ASD. By using smart tablet technology with built in 3 dimensional gyroscopes and accelerometers, we are now able to assess the movement of children with ASD as they interact with tablet screens during game play. It is proposed that this could be an enlightening avenue for assessment or even diagnosis of ASD.

The primary aim of this study is to clinically validate the ability of a new iPad game (called Play.Care) for diagnosis of ASD in children aged 30 months to 5 years (inclusive).

Three groups of participants will be recruited: children with a clinical diagnosis of ASD, children with a clinical diagnosis of an Other Neurodevelopmental Disorder (OND) and children developing typically (TD). A total of 760 children will be recruited between two cities, Glasgow, Scotland, United Kingdom and Gothenburg, Sweden. Gothenburgh will recruit 180 participants diagnosed with ASD, 60 participants diagnosed with OND and 100 typically developing participants. Glasgow will recruit 100 participants diagnosed with ASD, 140 participants diagnosed with OND and 180 participants developing typically.

Children developing typically will be recruited from local private nurseries. Children diagnosed with ASD or OND will be recruited from clinical diagnostic centres and specialist or inclusive schools.

Parents of children will be given a Participant Information Sheet and sign a Consent Form under protocol approved by health services (Glasgow and Gothenburg) and University ethics committees.

If the family is happy to participate, the child can either complete the Play.Care game in the clinic, during preschool hours in the preschool, or, if it is more suitable for the family, the researcher can come to their home. In either case, at the start of the data collection appointment, the parents must sign the consent form. Further information about the child's emotional state on the day of data collection will be recorded (e.g. mood, arousal, cooperativity). If the parents consented to their child being video recorded, a video camera will be setup prior to game play. This will give more information about the overall movement of the child as they play. The iPad will then be introduced to the child. Two games will be played. The first game is called 'Sharing' and requires the child to tap a piece of food to split it into 4 pieces and share it amongst game characters. The second game is called 'Creativity' and requires the child to choose an animal or object to trace and colour in. Each game has a two minute training phase followed by a five minute assessment phase. While the child is playing the games, or at an appropriate time, parents will be asked to complete 3 questionnaires about their child's everyday behaviour. These are standard assessments for children with ASD or OND and will help us understand how the information from Play.Care relates to everyday behaviour. These are the Strengths and Difficulties Questionnaire (SDQ), the Early Symptomatic Syndromes Eliciting Neurodevelopmental Clinical Examinations Questionnaire (ESSENCE-Q) and the Adaptive Behaviour Assessment Scale (ABAS). In some cases, information gathered during normal clinical assessment will also be gathered, namely but not exclusively the Vinelands Adaptive Behaviour Scale (VABS) and the Wechsler Preschool \& Primary Scale of Intelligence (WPPSI). Once the questionnaires and the Play.Care assessment are complete, no further participation is required.

Eligibility criteria: 1. Inclusion Criteria:

   1. All participants:

      * Aged 30 months - 5 years inclusive
   2. 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)
   3. 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
2. Exclusion Criteria:

   1. Typically developing participants:

      * Diagnosis or suspicion of
      * Neuropathology
      * Psychopathology
      * Sensory or motor disorder including mild tremors
   2. ASD participants:

      * Uncorrected sensory (visual, hearing) impairments
      * Presence of any motor impairments or behavioural impairment that may obstruct testing
   3. OND participants:

      * Sub-clinical or secondary expressions of ASD
      * Uncorrected hearing or vision impairments

Primary outcomes:
measure: Diagnostic accuracy of Play.Care to detect ASD
timeFrame: Single data collection time point of 15 minutes for each subject.
Secondary outcomes:
measure: Ability of Play.Care to distinguish ASD from OND
timeFrame: Single data collection time point of 15 minutes for each subject.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gillberg Neuropsychiatry Centre
city: Glasgow
country: United Kingdom
facility: University of Strathclyde
Study officials:
affiliation: jonathan.delafield-butt@strath.ac.uk
name: Jonathan Delafield-Butt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.