Using Serious Games to Improve Social Skills in Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Primary Target Eye Gaze Mechanisms - Performance Accuracy
研究概览
简要总结
The investigators will conduct a small-scale randomized control trial comparing the intervention game to an active control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). These outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to uncontrolled, real-world social interactions between dyads.
详细描述
The investigators will conduct a small-scale randomized control trial comparing the intervention game to an placebo control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). These outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to real-world social interactions between dyads. The aims are evaluating 1) changes in the target mechanisms (social attention to faces, sensitivity to eye gaze cues) for the intervention relative to active control group, 2) engagement of intermediate mechanisms, including face-processing behaviors and real-world social communication behaviors, and 3) the relation between engagement of the target and intermediate mechanisms and symptom outcomes. Evidence of changes in autism social symptoms resulting from changing visual attention to faces and/or improved ability to understand eye gaze cues will provide clear evidence to inform a "go" decision about the therapeutic target for further clinical development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded
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
- 是
入选标准
- •parent/caregiver of an adolescent with a diagnosis of autism spectrum disorder (ASD),
- •parent/caregiver and adolescent with ASD both native English speakers,
- •adolescent with ASD aged between 10-18 years at pre-test,
- •adolescent has normal vision and hearing with correction as reported by caregiver,
- •adolescent is able to use a computer for the purposes of game play,
- •adolescent scores < 80% correct (i.e., 0.5 SD less than Mean of typically developing adolescents) on online eye gaze screening task,
- •ASD diagnosis of adolescent confirmed via Parent-report SCQ and clinical interview with adolescent to assess DSM-V criteria (borderline cases also undergo ADI interview);
- •Full Scale IQ of adolescent determined to be between 70-130;
- •reading ability of adolescent determined to be at least a 2nd grade level;
- •adolescent is capable of cooperating with testing;
- •parent/caregiver and adolescent both consent/assent to participate in the research.
排除标准
- •having seizures within the previous two years
- •no stable internet connection in the home
- •refusing to consent/assent to take part in the research
- •18 and have a legal guardian, which prohibits them from legally consenting for themselves
- •18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.
研究组 & 干预措施
Intervention Video Game
Participants will play the Intervention Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session
干预措施: Intervention Video Game (Behavioral)
Control Video Game
Participants will play the Control Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session
干预措施: Placebo Control Game (Behavioral)
结局指标
主要结局
Primary Target Eye Gaze Mechanisms - Performance Accuracy
时间窗: 6 months
Performance accuracy will be acquired from both a static and a dynamic task of eye gaze cue following, which will be analyzed separately (ie 6 months from pre-intervention).
Primary Target Eye Gaze Mechanisms - Visual Fixation
时间窗: 6 months
Eye tracking measures of visual fixation will be acquired in both a static and a dynamic task of eye gaze cue following, which will be analyzed separately (ie 6 months from pre-intervention).
Social Symptoms - Social Skills Inventory System (SSIS)
时间窗: 6 months
Social skills and problematic behaviors will be assessed via parent- and self-reported responses on the SSIS. These measures will be administered at multiple time points including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).
Autism Behaviors - Social Responsiveness Scale 2nd Edition (SRS-2)
时间窗: 6 months
To assess potential changes in autism-like behaviors and symptoms, parents will complete the SRS-2 at each of 3 time points (pre-intervention, post-intervention, 3-month follow-up after intervention completion).
次要结局
- Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM)(6 months)
- Face-to-Face Social Interactions - Visual Fixations(6 months)
- Intermediate Face Processing Mechanisms - Face Identity (CFMT)(6 months)
- Intermediate Face Processing Mechanisms - Object Identity (CBMT)(6 months)
- Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET)(6 months)
研究者
K. Suzanne Scherf
Associate Professor of Psychology
Penn State University