Toward Early Autism Assessment: A Prospective Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 779
- 试验地点
- 3
- 主要终点
- Diagnostic accuracy of Play.Care to detect ASD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •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
排除标准
- •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
研究组 & 干预措施
Participants diagnosed with ASD
干预措施: Play.Care (Diagnostic Test)
Participants diagnosed with OND
干预措施: Play.Care (Diagnostic Test)
Typically developing participants
干预措施: Play.Care (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of Play.Care to detect ASD
时间窗: Single data collection time point of 15 minutes for each subject.
sensitivity and specificity of Play.Care to detect ASD
次要结局
- Ability of Play.Care to distinguish ASD from OND(Single data collection time point of 15 minutes for each subject.)
研究者
Jonathan Delafield-Butt
Principal Investigator, Director Laboratory for Innovation in Autism
University of Strathclyde