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:

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.

Study Overview

• Status: Unknown
• Conditions: Parents of Healthy Newborns
• Intervention / Treatment: Other: Genetics education at baseline; Other: Hypothetical genomic scenarios at follow-up

• Study Type: Interventional
• Enrollment (Actual): 1101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline1-demographics; Baseline survey- demographics only
Other: Baseline1 w/genetics; Genetics education, baseline interest in genome screening - 1	Other: Genetics education at baseline
Other: Baseline2-demographics; Baseline survey- demographics only	Other: Hypothetical genomic scenarios at follow-up
Other: Baseline2 w/genetics; Genetics education, baseline interest in genome screening - 2	Other: Genetics education at baseline; Other: Hypothetical genomic scenarios at follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interest in genome screening for newborn if this service were available through a research study	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 between baseline and 3-24 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of refusal of newborn screening	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.	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Stress	Parenting Stress Index- short form	3-28 month follow-up
Postpartum bonding	Postpartum Bonding Questionnaire	3-28 month follow-up

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Robert C. Green, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: November 1, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2012-P-001197