Surveying Parents About Genome Screening of Newborns (BabySeq)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Robert C. Green, MD, MPH, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT01736501

First received: November 1, 2012

Last updated: May 19, 2014

Last verified: May 2014

History of Changes

Tracking Information
First Received Date ^ICMJE	November 1, 2012
Last Updated Date	May 19, 2014
Start Date ^ICMJE	June 2012
Estimated Primary Completion Date	August 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 ] [ 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.
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 ] [ 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.
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 ] [ 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: May 19, 2014)	Parental Stress [ Time Frame: 3-24 month follow-up ] [ Designated as safety issue: No ] Parenting Stress Index- short form Postpartum bonding [ Time Frame: 3-24 month follow-up ] [ Designated as safety issue: No ] Postpartum Bonding Questionnaire
Original Other Outcome Measures ^ICMJE (submitted: November 26, 2012)	Parental Stress [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ] Parenting Stress Index- short form Postpartum bonding [ Time Frame: 3 month follow-up ] [ Designated as safety issue: Yes ] 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 Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Factorial Assignment Masking: 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 Arm (s)	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 *	Not Provided
* 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
Enrollment ^ICMJE	1096
Estimated Completion Date	August 2014
Estimated Primary Completion Date	August 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
Gender	Both
Ages	Not Provided
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
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	Not Provided
Information Provided By	Brigham and Women's Hospital
Verification Date	May 2014
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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