Validation of Indiana's Early Neurodevelopmental Evaluation Hub Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 7
- 主要终点
- Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
研究概览
简要总结
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the primary care setting.
详细描述
Determine whether eye-tracking biomarkers can reliably differentiate young children with and without autism in a community referred sample. The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. Differences in metrics between children with and without autism will be compared to validate potential eye-tracking biomarkers.
Determine whether a combination of clinical (i.e., EE Hub PCP measures) and eye-tracking biomarkers can be used to accurately predict autism diagnostic outcome in a sample of young children evaluated for autism in the primary care setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 14 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young children ages 14-48 months seen at an EE hub and referred for a comprehensive autism evaluation.
- •Children must have English-speaking caregivers. Children must have a legal guardian that is able to provide consent.
排除标准
- •Child is younger than 14 months or older than 48 months. Child's caregiver(s) is/are not English-speaking.
研究组 & 干预措施
Children Undergoing Developmental Evaluation
Participating EE Hubs referred a prospective, consecutive sample of children who received an EE Hub evaluation. Next, the study team traveled to the EE Hub to conduct a follow-up gold-standard autism diagnostic assessment (reference standard diagnosis) and eye-tracking biomarker battery (index test; Aim 2) within 16 weeks of EE Hub evaluation. Reference standard diagnosis was made by a licensed clinical psychologist with expertise in autism diagnosis based upon a research evaluation including the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Vineland Adaptive Behaviors Scale, Third Edition (VABS-3), Mullen Scales of Early Learning (MSEL), and a caregiver interview to assess for DSM-5 autism criteria. Children also completed a short (< 15min) eye-tracking activity where the children view a series of different images/videos while the children's eye movements and pupil diameter was measured.
干预措施: Eyelink Portable Duo (Diagnostic Test)
Children Undergoing Developmental Evaluation
Participating EE Hubs referred a prospective, consecutive sample of children who received an EE Hub evaluation. Next, the study team traveled to the EE Hub to conduct a follow-up gold-standard autism diagnostic assessment (reference standard diagnosis) and eye-tracking biomarker battery (index test; Aim 2) within 16 weeks of EE Hub evaluation. Reference standard diagnosis was made by a licensed clinical psychologist with expertise in autism diagnosis based upon a research evaluation including the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Vineland Adaptive Behaviors Scale, Third Edition (VABS-3), Mullen Scales of Early Learning (MSEL), and a caregiver interview to assess for DSM-5 autism criteria. Children also completed a short (< 15min) eye-tracking activity where the children view a series of different images/videos while the children's eye movements and pupil diameter was measured.
干预措施: Integrated PCP Diagnosis and Eye-tracking Biomarker (Diagnostic Test)
结局指标
主要结局
Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
时间窗: Day 1
Sensitivity and specificity of a composite eye-tracking (i.e., index) test, which was a consolidated measure based on significant eye-tracking indices, compared to reference standard expert clinical autism diagnosis.
Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist
时间窗: Day 1
Classification and Regression Tree (CART) analysis, based on recursive partitioning, is used to determine which combination of variables (EE Hub PCP diagnosis, diagnostic certainty, composite biomarker, and biomarker frequency \[sum of all individual biomarkers (0-6) that exceeded the 95% specificity threshold for each child\]) best predicted reference standard autism diagnosis.
次要结局
未报告次要终点
研究者
Rebecca McNally Keehn
Assistant Professor of Pediatrics
Indiana University