Parent Education and Choice About Newborn Screening and Bloodspot Retention
NCT ID: NCT02676245
Last Updated: 2016-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
664 participants
INTERVENTIONAL
2013-09-30
2014-10-31
Brief Summary
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Detailed Description
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To address this the project has the following specific aims:
Specific Aim 1) To determine what pregnant women, young mothers, and their partners want to know regarding the retention and use of residual bloodspot samples
Specific Aim 2) To create multimedia educational tools to be used in the prenatal care environment that will provide basic information about NBS and the core information determined through Specific Aim 1 about residual sample retention and use.
Specific Aim 3) To determine the impact of the prenatal education intervention on parental knowledge, attitudes, and decisions regarding NBS services and the retention and use of residual samples in diverse populations of English and Spanish speaking pregnant women.
Specific Aim 4) To examine the normative/ethical implications of the results of SA3 for the conduct of state NBS programs. Recommendations on the content and timing of parental NBS education will be developed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Viewing NBS + DBS Educational Movies
Group A: pregnant women who will view the NBS and residual specimen movies and printed materials during one visit between 30 and 40 weeks gestation.
Viewing Newborn Screening movie
NBS Movie and printed brochure were viewed by the participants
Viewing Residual Dried Blood Spot movie
DBS Movie and and printed brochure were viewed by the participants
Viewing NBS Educational Movie only
Group B: pregnant women who will view the NBS movie only and printed materials at one visit between 30 and 40 weeks. The movies will be presented on a tablet PC.
Viewing Newborn Screening movie
NBS Movie and printed brochure were viewed by the participants
No Educational Interventions
Control Group: pregnant women who will receive no experimental intervention during pregnancy or the postpartum period but will receive whatever information is routinely provided by their OB clinic and/or delivery center.
No interventions assigned to this group
Interventions
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Viewing Newborn Screening movie
NBS Movie and printed brochure were viewed by the participants
Viewing Residual Dried Blood Spot movie
DBS Movie and and printed brochure were viewed by the participants
Eligibility Criteria
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Inclusion Criteria
* Uncomplicated pregnancy
* English and Spanish speaking
* Partners of pregnant women who have give birth.
Exclusion Criteria
* Complicated pregnancy
18 Years
ALL
No
Sponsors
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Case Western Reserve University
OTHER
Intermountain Health Care, Inc.
OTHER
Albert Einstein College of Medicine
OTHER
University of California, San Francisco
OTHER
National Human Genome Research Institute (NHGRI)
NIH
University of Utah
OTHER
Responsible Party
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Jeffrey Botkin
Professor of Pediatrics, Chief Division of Medical Ethics and Humanities, Associate Vice President for Research
Principal Investigators
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Jeffrey R Botkin, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Utah
References
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Botkin JR, Rothwell E, Anderson RA, Goldenberg A, Kuppermann M, Dolan SM, Rose NC, Stark L. What parents want to know about the storage and use of residual newborn bloodspots. Am J Med Genet A. 2014 Nov;164A(11):2739-44. doi: 10.1002/ajmg.a.36694. Epub 2014 Aug 4.
Botkin JR, Rothwell E, Anderson RA, Rose NC, Dolan SM, Kuppermann M, Stark LA, Goldenberg A, Wong B. Prenatal Education of Parents About Newborn Screening and Residual Dried Blood Spots: A Randomized Clinical Trial. JAMA Pediatr. 2016 Jun 1;170(6):543-9. doi: 10.1001/jamapediatrics.2015.4850.
Other Identifiers
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IRB_00060088
Identifier Type: -
Identifier Source: org_study_id
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