Surveying Parents About Genome Screening of Newborns (BabySeq)
|ClinicalTrials.gov Identifier: NCT01736501|
Recruitment Status : Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : July 12, 2017
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.
|Condition or disease||Intervention/treatment|
|Parents of Healthy Newborns||Other: Genetics education at baseline Other: Hypothetical genomic scenarios at follow-up|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1101 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Surveying Parents About Genome Screening of Newborns|
|Study Start Date :||June 2012|
|Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||August 2017|
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|
- 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 ]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 ]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 ]Parenting Stress Index- short form
- Postpartum bonding [ Time Frame: 3-28 month follow-up ]Postpartum Bonding Questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|