Parent Education and Choice About Newborn Screening and Bloodspot Retention

Neonatal Screening Clinical Trial

Official title:

Parent Education and Choice About Newborn Screening and Bloodspot Retention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676245
• Other study ID #: IRB_00060088
• Secondary ID: R01HG006266
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: February 3, 2016
• Start date: September 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (> 18 years) women

• Uncomplicated pregnancy

• English and Spanish speaking

• Partners of pregnant women who have give birth.

Exclusion Criteria:

• Women younger than 18 years

• Complicated pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Neonatal Screening

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University of Utah	Albert Einstein College of Medicine of Yeshiva University, Case Western Reserve University, Intermountain Health Care, Inc., National Human Genome Research Institute (NHGRI), University of California, San Francisco

References & Publications (1)

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factual knowledge about newborn screening as assessed through a survey instrument designed for the project	Knowledge of key items about newborn screening that were conveyed in the educational interventions	2-4 weeks after due date	No
Primary	Factual knowledge about newborn blood spots retention and use as assessed through a survey instrument designed for the project	Knowledge of key items about newborn dried blood spots that were conveyed in the educational interventions	2-4 weeks after due date	No
Secondary	Knowledge of partners of the pregnant women regarding newborn screening based on a survey instrument designed for the study	Knowledge of newborn screening	2-4 weeks after due date	No
Secondary	Knowledge of partners of the pregnant women regarding newborn dried blood spots retention and use based on a survey instrument designed for the study	Knowledge of newborn dried blood spots	2-4 weeks after due date	No
Secondary	An attitude assessment regarding support for newborn screening programs	Attitudes regarding support for newborn screening	2-4 weeks after due date	No
Secondary	An attitude assessment regarding support for retention and use of newborn residual dried blood spots	Attitudes regarding support for newborn dried blood spots	2-4 weeks after due date	No
Secondary	The clinical choices made by participants regarding participation in newborn screening	Parents choice about newborn screening	2-4 weeks after due date	No
Secondary	The clinical choices made by participants regarding participation in the retention and use of dried blood spots	Parents choice about dried bloodspot retention	2-4 weeks after due date	Yes