Surveying Parents About Genome Screening of Newborns
This trial is active, not recruiting.
|Condition||parents of healthy newborns|
|Treatments||genetics education at baseline, hypothetical genomic scenarios at follow-up|
|Sponsor||Brigham and Women's Hospital|
|Start date||June 2012|
|End date||September 2014|
|Trial size||1101 participants|
|Trial identifier||NCT01736501, 2012-P-001197|
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:
1. 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.
1. 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.
|Intervention model||factorial assignment|
|Primary purpose||health services research|
Interest in genome screening for newborn if this service were available through a research study
time frame: Change between baseline and 3-24 month follow-up
Rate of refusal of newborn screening
time frame: baseline
Male or female participants of any age.
- Parent of a healthy newborn in the BWH Department of Obstetrics
- Impaired decision-making capacity
- Newborn with life-threatening health concerns in the 48 hours post-partum
|Official title||Surveying Parents About Genome Screening of Newborns|
|Principal investigator||Robert C. Green, MD, MPH|
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