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
  Purpose

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.

Condition Intervention
Parents of Healthy Newborns
Other: Genetics education at baseline
Other: Hypothetical genomic scenarios at follow-up

Study Type: Interventional
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

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Enrollment: 1096
Study Start Date: June 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline1-demographics
Baseline survey- demographics only
Baseline1 w/genetics
Genetics education, baseline interest in genome screening - 1
Other: Genetics education at baseline
Baseline2-demographics
Baseline survey- demographics only
Other: Hypothetical genomic scenarios at follow-up
Baseline2 w/genetics
Genetics education, baseline interest in genome screening - 2
Other: Genetics education at baseline Other: Hypothetical genomic scenarios at follow-up

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736501

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Robert C. Green, MD, MPH, Lecturer on Medicine & Associate Director for Research, Partners Center for Personalized Genetic Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01736501     History of Changes
Other Study ID Numbers: 2012-P-001197
Study First Received: November 1, 2012
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014