Neonatal ScreeningNCT02676245
Parent Education and Choice About Newborn Screening and Bloodspot Retention
A study testing Viewing Newborn Screening movie and Viewing Residual Dried Blood Spot movie in people with Neonatal Screening, run by University of Utah.
Trial summary
To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neonatal Screening
- What is being tested?
- Viewing Newborn Screening movie and Viewing Residual Dried Blood Spot movie
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 664 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (> 18 years) women
- Uncomplicated pregnancy
- English and Spanish speaking
- Partners of pregnant women who have give birth.
Who cannot join
- Women younger than 18 years
- Complicated pregnancy
About this study
To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically.
Read the 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.
- Conditions
- Neonatal Screening
- Being tested
- Viewing Newborn Screening movie, Viewing Residual Dried Blood Spot movie
- Keywords
- Prenatal Education, Residual Specimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viewing Newborn Screening movieBehavioural
NBS Movie and printed brochure were viewed by the participants
Viewing Residual Dried Blood Spot movieBehavioural
DBS Movie and and printed brochure were viewed by the participants
| Study group | Role | What they receive |
|---|---|---|
| Viewing NBS + DBS Educational Movies | Experimental | 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. Receives: Behavioral: Viewing Newborn Screening movie; Behavioral: Viewing Residual Dried Blood Spot movie |
| Viewing NBS Educational Movie only | Experimental | 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. Receives: Behavioral: Viewing Newborn Screening movie |
| No Educational Interventions | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Knowledge of key items about newborn dried blood spots that were conveyed in the educational interventions
Measured: 2-4 weeks after due date
Secondary outcomes (6)
Knowledge of partners of the pregnant women regarding newborn screening based on a survey instrument designed for the study
Knowledge of newborn screening
Measured: 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
Knowledge of newborn dried blood spots
Measured: 2-4 weeks after due date
An attitude assessment regarding support for newborn screening programs
Attitudes regarding support for newborn screening
Measured: 2-4 weeks after due date
An attitude assessment regarding support for retention and use of newborn residual dried blood spots
Attitudes regarding support for newborn dried blood spots
Measured: 2-4 weeks after due date
The clinical choices made by participants regarding participation in newborn screening
Parents choice about newborn screening
Measured: 2-4 weeks after due date
The clinical choices made by participants regarding participation in the retention and use of dried blood spots
Parents choice about dried bloodspot retention
Measured: 2-4 weeks after due date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal ScreeningStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Intermountain Health Care, Inc., Albert Einstein College of Medicine, University of California, San Francisco, National Human Genome Research Institute (NHGRI)
- Responsible party
- Principal investigator, Jeffrey Botkin, University of Utah
- Investigators
- Jeffrey R Botkin, MD, MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676245
- Sponsor's protocol ID
- IRB_00060088
- Other IDs
- R01HG006266
- Status last verified
- Feb 2016
- First submitted
- 17 Nov 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25131714Botkin 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.
PubMed 27043416
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Education and Choice About Newborn Screening and Bloodspot Retention
- ClinicalTrials.gov ID
- NCT02676245
- Acronym / sponsor ID
- IRB_00060088
- Conditions
- Neonatal Screening
- Keywords
- Prenatal Education, Residual Specimens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Intermountain Health Care, Inc., Albert Einstein College of Medicine, University of California, San Francisco, National Human Genome Research Institute (NHGRI)
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Viewing NBS + DBS Educational Movies | Experimental | Behavioral: Viewing Newborn Screening movie, Behavioral: Viewing Residual Dried Blood Spot movieGroup 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 | Experimental | Behavioral: Viewing Newborn Screening movieGroup 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. |
| No Educational Interventions | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (> 18 years) women
- Uncomplicated pregnancy
- English and Spanish speaking
- Partners of pregnant women who have give birth.
Key exclusion criteria (2 listed)
- Women younger than 18 years
- Complicated pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viewing Newborn Screening movieNBS Movie and printed brochure were viewed by the participants | Behavioural | Viewing NBS + DBS Educational Movies, Viewing NBS Educational Movie only |
| Viewing Residual Dried Blood Spot movieDBS Movie and and printed brochure were viewed by the participants | Behavioural | Viewing NBS + DBS Educational Movies |
Primary outcome
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
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
6 secondary outcomes
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 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
An attitude assessment regarding support for newborn screening programs
Time frame: 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
The clinical choices made by participants regarding participation in newborn screening
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Results publication: PubMed 25131714Botkin 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.
- Derived from this study: PubMed 27043416Botkin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey R Botkin, MD, MPH principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing Viewing Newborn Screening movie and Viewing Residual Dried Blood Spot movie in people with Neonatal Screening, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factual knowledge about newborn screening as assessed through a survey instrument designed for the project (time frame: 2-4 weeks after due date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676245, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.