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临床试验/NCT03672344
NCT03672344已完成不适用

Computer-based Social Skills Training for Autism Spectrum Disorder

BioStream Technologies, LLC20 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
20
主要终点
Ekman-60 Faces Test

研究概览

简要总结

The primary objective of this study is to evaluate changes in subject performance on social skills assessments after engaging in a gaze-controlled video game that leverages ABA principles of learning, in comparison to an alternative game. The secondary objectives of this study are to evaluate changes in subject gaze patterns during social skills assessments after engaging in the video game, including in comparison to an alternative game and to evaluate possible correlations in changes in social skills assessments with changes in subject game play performance.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Meets diagnostic criteria for ASD.
  • Estimated intelligence standard score of at least 40 (can be substituted for a receptive language score such as PPVT or use of the Differential Ability Scales, 2nd Edition (DAS-II)).
  • Parent reports difficulty with at least one of two social skills (via modified questions from the Social Responsiveness Scale)
  • English as the child's primary/first language (key measures used in the study do not have alternate language versions).
  • Attains a score equal to or less than 75% correct on the Ekman 60 Faces Test
  • The parent who completes the questionnaires needs to be proficient in English.
  • Has successfully played a video game using a Microsoft Xbox game controller, Sony PlayStation game controller, or other comparable game controller.
  • Parental/guardian permission (informed consent) and if appropriate, child assent.
  • Wi-Fi internet connection at subject's home/school/therapy center/research organization available for use by study laptop computer.

排除标准

  • History of seizures.
  • History of traumatic brain injury or other significant medical or neurological abnormality affecting motor or higher cortical functioning.
  • Certain visual, auditory, DSM 5, or conduct disorders (see below).
  • A visual disorder that cannot be corrected through the use of corrective lenses to a level of 20-40 in both eyes.
  • Use of corrective visual lenses that would significantly impede the valid collection of visual attention and gaze pattern data during dyadic interaction tasks.
  • Auditory impairment (that cannot be corrected by a hearing aid) that would significantly impede the valid collection of test measures.
  • Profound intellectual disability or sensory-motor difficulties that would preclude valid use of diagnostic instruments and/or use of a computer or mobile computing device.
  • A DSM 5 disorder or other psychiatric symptoms that would interfere with the participant's ability to participate in the study (e.g., active psychosis), per parent report.
  • History of one or more psychiatric hospitalizations.
  • Presence of significant symptoms of a conduct disorder.

结局指标

主要结局

Ekman-60 Faces Test

时间窗: 6 Weeks

The Ekman-60 Faces Test is used to assesses emotion recognition using pictures. In this study, children were presented with 60 faces across 10 actors displaying six basic emotions (i.e., happiness, sadness, disgust, fear, surprise, and anger). Facial expressions are displayed on the computer for five seconds, after which the image disappears, and participants select from a list of emotions which best described the facial expression shown. Correct responses are summed to create a total score with a possible range from 0-60, and higher scores indicate better emotion recognition.

Social Responsiveness Scale

时间窗: 6 Weeks

The Social Responsiveness Scale is used to identify social impairment in children with autism spectrum disorder. The measure consists of five subscales: social motivation; social awareness; social cognition; social communication; and restricted interests and repetitive behavior, each with items scored on a scale from 1 to 4. A total score can be computed by summing scores across subscales, including, or excluding the restricted interests and repetitive behavior subscale. In this study, response options were re-coded from a scale of 1 to 4, to 0 to 3. Scores were then summed across four subscales, excluding the restrictive and repetitive behavior subscale. Possible scores ranged from 0 to 195, with higher scores meaning a better outcome.

次要结局

  • Childhood Joint Attention Rating Scale(6 Weeks)

研究者

发起方
BioStream Technologies, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (20)

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