Neonatal Screening Clinical Trial
Official title:
Parent Education and Choice About Newborn Screening and Bloodspot Retention
To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically.
It is widely recognized that new parents receive insufficient information about newborn
screening (NBS) and little or no information regarding the retention of residual newborn
screening samples. Our current research (R01 HD058854) clearly demonstrates that parents are
supportive of NBS and the research use of residual specimens, but they want information
before the child is born and want an informed choice regarding the retention and use of
residual samples. Previous research has outlined the basic elements of what parents want to
know about NBS generally. However, given that many states are adopting an "opt-out" approach
for residual samples, it is unclear what basic information parents want to know to enable an
informed choice about this practice. While it is recognized that retention and use of
residual NBS samples is a valuable research resource, there are prevalent concerns in the
NBS community that discussion of this will lead some parents to decline NBS altogether. Some
authorities have suggested that discussions of NBS and residual sample retention be
conducted separately to reduce the risk that parents will confuse the issues and decline NBS
altogether.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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