The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Agreement between eye-tracking biomarker score and autism diagnosis
研究概览
简要总结
The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures to determine whether these can predict autism diagnoses in both children exposed to HIV and uninfected (CHEU) and children not exposed to HIV and uninfected (CHUU).
详细描述
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 outcomes. Investigators will recruit children enrolled in the Tabiri study during or following their 24-month visit.
The Tabiri study is comparing neurodevelopmental (ND) outcomes between 24-month-old CHEU and CHUU.
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
- 24 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children enrolled in the Tabiri study (R01HD104552)
- •CHEU or CHUU
- •Children ages 24-72 months
- •Caregivers of children must speak Kiswahili (local language) or English.
排除标准
- •There will be no specific exclusion criteria. We anticipate that a small number of CHEU and CHUU will develop HIV prior to enrollment in the current study; these children will be included and will follow all general study procedures.
研究组 & 干预措施
Children Undergoing Developmental Evaluation for Autism
Young children (ages 24-72 month) who are HIV exposed but uninfected (CHEU) and young children who are HIV unexposed but uninfected (CHUU) undergoing a standard of care developmental evaluation will be enrolled into the study. After the completion of the developmental evaluation, research participation includes a one-time eye-tracking activity in which the child will view a series of different pictures and movies while their eye movements and pupil diameter are tracked and recorded.
干预措施: Eyelink Portable Duo (Diagnostic Test)
结局指标
主要结局
Agreement between eye-tracking biomarker score and autism diagnosis
时间窗: Day 1
The composite eye-tracking biomarker score, a consolidated measure based on eye-tracking indices that predict autism outcome, will be compared to the categorical autism diagnosis (autism presence/absence). Clinical diagnosis is obtained based upon a standard clinical evaluation. The evaluation will include 1) a semi-structured caregiver(s) clinical interview to gather information about developmental history and autism symptoms and 2) a battery of standardized child clinical observational measures. The evaluation will be conducted over a one-time 2- to 3-hour clinical autism evaluation. Eye-tracking will be recorded immediately following the clinical evaluation.
次要结局
未报告次要终点
研究者
Rebecca McNally Keehn
Assistant Professor of Pediatrics
Indiana University