Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
NONE
Study Groups
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Baseline1-demographics
Baseline survey- demographics only
No interventions assigned to this group
Baseline1 w/genetics
Genetics education, baseline interest in genome screening - 1
Genetics education at baseline
Baseline2-demographics
Baseline survey- demographics only
Hypothetical genomic scenarios at follow-up
Baseline2 w/genetics
Genetics education, baseline interest in genome screening - 2
Genetics education at baseline
Hypothetical genomic scenarios at follow-up
Interventions
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Genetics education at baseline
Hypothetical genomic scenarios at follow-up
Eligibility Criteria
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Inclusion Criteria
* English-speaking
Exclusion Criteria
* Newborn with life-threatening health concerns in the 48 hours post-partum
ALL
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Robert C. Green, MD, MPH
Lecturer on Medicine & Associate Director for Research, Partners Center for Personalized Genetic Medicine
Principal Investigators
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Robert C. Green, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Waisbren SE, Back DK, Liu C, Kalia SS, Ringer SA, Holm IA, Green RC. Parents are interested in newborn genomic testing during the early postpartum period. Genet Med. 2015 Jun;17(6):501-4. doi: 10.1038/gim.2014.139. Epub 2014 Dec 4.
Other Identifiers
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2012-P-001197
Identifier Type: -
Identifier Source: org_study_id