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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: July 20, 2015
Last verified: July 2015
History of Changes

November 1, 2012
July 20, 2015
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 ] [ 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.
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.
Complete list of historical versions of study NCT01736501 on ClinicalTrials.gov Archive Site
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.
Same as current
  • Parental Stress [ Time Frame: 3-28 month follow-up ] [ Designated as safety issue: No ]
    Parenting Stress Index- short form
  • Postpartum bonding [ Time Frame: 3-28 month follow-up ] [ Designated as safety issue: No ]
    Postpartum Bonding Questionnaire
  • 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
 
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: 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 2016
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
Both
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 2015

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