Surveying Parents About Genome Screening of Newborns (BabySeq)
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.
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.
Parents of Healthy Newborns
Other: Genetics education at baseline
Other: Hypothetical genomic scenarios at follow-up
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Surveying Parents About Genome Screening of Newborns|
- 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 ] [ Designated as safety issue: No ]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.
- Rate of refusal of newborn screening [ Time Frame: baseline ] [ Designated as safety issue: Yes ]Newborn screening refusals are very rare. When they occur, they are tracked by nurses on the postpartum inpatient unit. At the start of all shifts for study recruitment, the research assistant will ask the nurse-in-charge if any patients refused newborn screening since the previous study recruitment shift.
- Parental Stress [ Time Frame: 3-28 month follow-up ] [ Designated as safety issue: No ]Parenting Stress Index- short form
- Postpartum bonding [ Time Frame: 3-28 month follow-up ] [ Designated as safety issue: No ]Postpartum Bonding Questionnaire
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||August 2016|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
No Intervention: Baseline1-demographics
Baseline survey- demographics only
Genetics education, baseline interest in genome screening - 1
|Other: Genetics education at baseline|
Baseline survey- demographics only
|Other: Hypothetical genomic scenarios at follow-up|
Genetics education, baseline interest in genome screening - 2
|Other: Genetics education at baseline Other: Hypothetical genomic scenarios at follow-up|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736501
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Robert C. Green, MD, MPH||Brigham and Women's Hospital|