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临床试验/NCT02968225
NCT02968225已完成2 期

Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism

Penn State University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Social/Visual Attention Task

研究概览

简要总结

The investigators hypothesize that this serious game (designed to provide a learning environment that maximizes opportunities for adolescents with autism to discover the functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to identify gazed-at objects, and will also lead to increased social attention to faces in adolescents with autism. The investigators will test this hypothesis in a small-scale exploratory randomized control trial that will include both behavioral and eye tracking outcome measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Given the design of the study, parents and adolescents will know the condition to which they have been assigned. However, researchers involved in data collection will be blinded from condition assignment during the pre-intervention data collection session as these data will be collected prior to randomization. Also, the research team is not involved in the randomization process. The research team members who are involved in ensuring the fidelity of the intervention are not involved in data collection procedures. Although we will attempt to limit unblinding, it is not possible for researchers involved in data collection to be completely blinded to the assignment of participant condition at the post-intervention visit as we cannot prohibit participants from talking to researchers about their experience in the study. Importantly, the primary outcome measures are believed to be robust to investigator bias.

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • parent/caregiver of an adolescent with a diagnosis of ASD,
  • parent/caregiver and adolescent with ASD both native English speakers,
  • adolescent with ASD aged between 10-18 years at enrollment,
  • adolescent has normal vision and hearing with correction as indicated by parent report,
  • adolescent is able to use a computer for the purposes of game play,
  • adolescent scores > 80% correct (i.e., 0.5 SD less than M of TD adolescents) on online eye gaze screening task,
  • ASD diagnosis of adolescent confirmed in lab via the Autism Diagnostic Observation Schedule,
  • Full Scale IQ of adolescent determined to be between 70-130 on the Kaufman Brief Intelligence Test,
  • reading ability of adolescent determined to be at least a second grade level as assessed by the Oral and Written Language Scales,
  • adolescent is capable of cooperating with testing,
  • parent/caregiver and adolescent both consent/assent to participate in the research.

排除标准

  • adolescent has had seizures within the previous two years,
  • family lacks stable home internet,
  • parent or adolescent refuses to consent/assent to take part in the research,
  • adolescent is 18 and has a legal guardian, prohibiting him/her from legally consenting, or
  • adolescent is 18 and cannot understand the consent (i.e., fails consent quiz).

研究组 & 干预措施

Computer Game

Experimental

All Computer Game participants will complete:

  • online screening
  • Diagnostic and eye-tracking pre-testing
  • 2 month intervention
  • Eye-tracking post-testing

干预措施: Computer Game (Behavioral)

Waitlist control

No Intervention

All Treatment as usual control participants will complete:

  • online screening
  • Diagnostic and eye-tracking pre-testing
  • Eye-tracking post-testing

结局指标

主要结局

Social/Visual Attention Task

时间窗: 2 Months

Eye tracking

Static Eye Gaze Following Task

时间窗: 2 months

Eye tracking and accuracy

Dynamic Eye Gaze Following Task

时间窗: 2 Months

Eye tracking and accuracy

次要结局

  • Social Skills Inventory System - Child version(2 months)
  • Social Responsiveness Scale(2 months)
  • Treatment as Usual(2 months)
  • Social Skills Inventory System - Adult version(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

K. Suzanne Scherf

Associate Professor of Psychology

Penn State University

研究点 (1)

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