Parent Education and Choice About Newborn Screening and Bloodspot Retention

February 3, 2016 updated by: Jeffrey Botkin, University of Utah
To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

664

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Viewing Newborn Screening movie
NBS Movie and printed brochure were viewed by the participants
Behavioral: Viewing Residual Dried Blood Spot movie
DBS Movie and and printed brochure were viewed by the participants
Experimental: 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.
Behavioral: Viewing Newborn Screening movie
NBS Movie and printed brochure were viewed by the participants
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

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

Investigators

  • Principal Investigator: Jeffrey R Botkin, MD, MPH, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 3, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB_00060088
  • R01HG006266 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neonatal Screening

Clinical Trials on Viewing Newborn Screening movie

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe