Surveying Parents About Genome Screening of Newborns (BabySeq)

Tracking Information
First Submitted Date ICMJE	November 1, 2012
First Posted Date ICMJE	November 29, 2012
Last Update Posted Date	July 12, 2017
Study Start Date ICMJE	June 2012
Actual Primary Completion Date	September 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 19, 2014)	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.
Original Primary Outcome Measures ICMJE; (submitted: November 26, 2012)	Interest in genome screening for newborn if this service were available through a research study [ Time Frame: Change between baseline and 3-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.
Change History	Complete list of historical versions of study NCT01736501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 26, 2012)	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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE; (submitted: July 20, 2015)	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
Original Other Outcome Measures ICMJE; (submitted: November 26, 2012)	Parental Stress [ Time Frame: 3-month follow-up ]Parenting Stress Index- short form; Postpartum bonding [ Time Frame: 3 month follow-up ]Postpartum Bonding Questionnaire
Descriptive Information
Brief Title ICMJE	Surveying Parents About Genome Screening of Newborns
Official Title ICMJE	Surveying Parents About Genome Screening of Newborns
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
Condition ICMJE	Parents of Healthy Newborns
Intervention ICMJE	Other: Genetics education at baseline; Other: Hypothetical genomic scenarios at follow-up
Study Arms	No Intervention: Baseline1-demographics Baseline survey- demographics only; Baseline1 w/genetics Genetics education, baseline interest in genome screening - 1 Intervention: Other: Genetics education at baseline; Baseline2-demographics Baseline survey- demographics only Intervention: Other: Hypothetical genomic scenarios at follow-up; Baseline2 w/genetics Genetics education, baseline interest in genome screening - 2 Interventions: Other: Genetics education at baseline Other: Hypothetical genomic scenarios at follow-up
Publications *	Waisbren SE, Bäck 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: July 20, 2015)	1101
Original Estimated Enrollment ICMJE; (submitted: November 26, 2012)	1000
Estimated Study Completion Date	August 2017
Actual Primary Completion Date	September 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Parent of a healthy newborn in the BWH Department of Obstetrics; English-speaking Exclusion Criteria: Impaired decision-making capacity; Newborn with life-threatening health concerns in the 48 hours post-partum
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01736501
Other Study ID Numbers ICMJE	2012-P-001197
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Robert C. Green, MD, MPH, Brigham and Women's Hospital
Study Sponsor ICMJE	Brigham and Women's Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Robert C. Green, MD, MPH Brigham and Women's Hospital
PRS Account	Brigham and Women's Hospital
Verification Date	July 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP