Parent Education and Choice About Newborn Screening and Bloodspot Retention

Not Applicable

Completed

• Conditions: Neonatal Screening
• Interventions: Behavioral: Viewing Newborn Screening movie; Behavioral: Viewing Residual Dried Blood Spot movie

• Registration Number: NCT02676245
• Lead Sponsor: University of Utah

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2015-11-17
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-03
• Last Update Submitted: 2016-02-03
• Study First Posted: 2016-02-08
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

Inclusion Criteria

• Adult (> 18 years) women
• Uncomplicated pregnancy
• English and Spanish speaking
• Partners of pregnant women who have give birth.

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Exclusion Criteria

• Women younger than 18 years
• Complicated pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viewing NBS + DBS Educational Movies	Viewing Newborn Screening movie	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 NBS Educational Movie only	Viewing Newborn Screening movie	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 NBS + DBS Educational Movies	Viewing Residual Dried Blood Spot movie	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.

Primary Outcome Measures

Name	Time	Method
Factual knowledge about newborn blood spots retention and use as assessed through a survey instrument designed for the project	2-4 weeks after due date	Knowledge of key items about newborn dried blood spots that were conveyed in the educational interventions
Factual knowledge about newborn screening as assessed through a survey instrument designed for the project	2-4 weeks after due date	Knowledge of key items about newborn screening that were conveyed in the educational interventions

Secondary Outcome Measures

Name	Time	Method
The clinical choices made by participants regarding participation in newborn screening	2-4 weeks after due date	Parents choice about newborn screening
Knowledge of partners of the pregnant women regarding newborn screening based on a survey instrument designed for the study	2-4 weeks after due date	Knowledge of newborn screening
Knowledge of partners of the pregnant women regarding newborn dried blood spots retention and use based on a survey instrument designed for the study	2-4 weeks after due date	Knowledge of newborn dried blood spots
An attitude assessment regarding support for retention and use of newborn residual dried blood spots	2-4 weeks after due date	Attitudes regarding support for newborn dried blood spots
An attitude assessment regarding support for newborn screening programs	2-4 weeks after due date	Attitudes regarding support for newborn screening
The clinical choices made by participants regarding participation in the retention and use of dried blood spots	2-4 weeks after due date	Parents choice about dried bloodspot retention