Tracking Intervention Effects With Eye Tracking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Laboratory Eye Tracking Measuring Longitudinal Change
研究概览
简要总结
This pilot study examines concurrent and predictive relationships between eye tracking and clinical outcomes during a 16-week behavioral intervention (PRT) for children with ASD. Eye tracking will be comprised of both laboratory-based measures (using a commercial eye-tracking system) as well as home-based measures (using tablet-based eye tracking systems). The major goals of this study are both to improve our understanding of the potential role of eye tracking in clinical trials and to advance technologies that may further improve the sensitivity, robustness, accessibility, and ultimate utility of eye tracking methodologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals ages 4-7 years diagnosed previously with ASD and meet criteria for ASD when characterized by our research team, English is a language spoken in the family, and Full-scale IQ>
- •Participants must also complete laboratory and home-based eye tracking sessions, with success determined by the Principal Investigator.
排除标准
- •Individuals will be excluded from participation based on the presence of
- •a physical or neurological disorder (e.g., cerebral palsy) which is likely to impact development and learning, as intervention procedures for these individuals may need to be modified beyond the standard approach to address more complex developmental needs,
- •hearing loss or other severe sensory impairment,
- •history of significant head trauma or serious brain or psychiatric illness,
- •parents/caregivers who do not speak fluent English,
- •parents/caregivers who have previous training in PRT
- •individuals who must be excluded from eye tracking. These families will be offered the treatment clinically (i.e., fee-based), and they will be given referrals to outside agencies offering the treatment as well.
研究组 & 干预措施
PRT
Children with ASD who are currently receiving PRT treatment.
干预措施: Pivotal Response Treatment (Behavioral)
Wait List / Non-Treatment Control
Children with ASD who are not currently receiving PRT treatment.
Typically Developing
Children without ASD or developmental delay.
结局指标
主要结局
Laboratory Eye Tracking Measuring Longitudinal Change
时间窗: 16 Weeks
A comprehensive laboratory eye-tracking battery will be administered to participants before, at midpoint, and at the end of a 16-week period to assess change over the course of treatment.
Home-Based Eye Tracking
时间窗: 16 Weeks
Participants will also receive a tablet equipped with eye-tracking paradigms specifically designed for continuous monitoring in homes. Caregivers will be asked to complete a brief questionnaire
Longitudinal Change in Autism Symptom Severity
时间窗: 16 Weeks
Clinical assessments and caregiver surveys will be administered at baseline. A subset of measures will be administered again post-study. Assessments include the Autism Diagnostic Observation Schedule™ Second Edition (ADOS™-2), Autism Diagnostic Interview™ Revised (ADI™-R), Social Responsiveness Scale™ (SRS™), Repetitive Behaviors Scale - Revised (RBS-R), Differential Ability Scales®-II (DAS-II®), Vineland Adaptive Behavior Scales™ Second Edition (Vineland™-II), and the Child Behavior Checklist (CBCL).
次要结局
未报告次要终点