Surveying Parents About Genome Screening of Newborns
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 1,101
- 试验地点
- 2
- 主要终点
- Interest in genome screening for newborn if this service were available through a research study
研究概览
简要总结
A 10 minute baseline survey will be administered to parents of healthy newborn infants while in the hospital after delivery at Brigham and Women's Hospital, to be followed by a 25 minute survey 3-24 months later. We will measure parents' attitudes and preferences related to genome screening of newborns. The specific aims of this study are:
- To investigate whether parents' opinions regarding genome screening of newborns change between the first 48 hours post-partum and 3-24 months post-partum.
a. We hypothesize that there will not be significant differences between interest in genome screening results in the 48 hours post-partum compared to 3-24 months post-partum. 2. To determine whether seeing hypothetical genome screening results affects parents' decisions regarding whether they would want genome screening for their newborn.
- We expect many parents to state initially (in the 48 hours post-partum) that they would elect to have genome screening for their newborn if it were available. In the follow-up survey, half of study participants will receive hypothetical scenarios in which they will need to struggle with the probabilistic and ambiguous nature of the information that could be derived from genome sequencing. We will examine whether this alters their preferences. We will also explore whether parents who receive hypothetical genome screening results scenarios are more likely to alter their preferences than parents who do not receive hypothetical scenarios.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent of a healthy newborn in the BWH Department of Obstetrics
- •English-speaking
排除标准
- •Impaired decision-making capacity
- •Newborn with life-threatening health concerns in the 48 hours post-partum
结局指标
主要结局
Interest in genome screening for newborn if this service were available through a research study
时间窗: Change between baseline and 3-24 month follow-up
This is a question created by the investigators. It uses a 5-point Likert scale to measure parents' self-reported interest in genome screening for their newborn.
次要结局
- Rate of refusal of newborn screening(baseline)
研究者
Robert C. Green, MD, MPH
Lecturer on Medicine & Associate Director for Research, Partners Center for Personalized Genetic Medicine
Brigham and Women's Hospital
