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Surveying Parents About Genome Screening of Newborns (BabySeq)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736501
First Posted: November 29, 2012
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert C. Green, MD, MPH, Brigham and Women's Hospital
November 1, 2012
November 29, 2012
July 12, 2017
June 2012
September 2014   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01736501 on ClinicalTrials.gov Archive Site
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.
Same as current
  • 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
  • Parental Stress [ Time Frame: 3-month follow-up ]
    Parenting Stress Index- short form
  • Postpartum bonding [ Time Frame: 3 month follow-up ]
    Postpartum Bonding Questionnaire
 
Surveying Parents About Genome Screening of Newborns
Surveying Parents About Genome Screening of Newborns

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Parents of Healthy Newborns
  • Other: Genetics education at baseline
  • Other: Hypothetical genomic scenarios at follow-up
  • 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
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.
 
Active, not recruiting
1101
August 2017
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01736501
2012-P-001197
No
Not Provided
Not Provided
Robert C. Green, MD, MPH, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Robert C. Green, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP