Pregnancy - Prenatal TestingNCT00514553
Informed Choice Regarding Invasive Prenatal Testing
An observational study of Pregnancy - Prenatal Testing, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will compare the effectiveness of two interventions to help women make informed choices about whether or not to undergo an invasive procedure (amniocentesis or chorionic villus sampling) for prenatal testing. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pregnancy - Prenatal Testing
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2007to 31 May 2011
- Phase
- Observational
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women referred for prenatal genetic counseling to consider invasive prenatal testing who have not previously undergone prenatal testing.
- Women who are ambivalent about undergoing prenatal testing. They will be screened for ambivalence by answering no to a question about whether they have decided to undergo prenatal testing and yes to a close-ended question about whether you have mixed or conflicting feelings toward undergoing testing.
- Women must be greater than or equal to 18 years old.
- Participants must speak English
- Participants must be competent to consent to participate in the study.
Who cannot join
- Men
- Participants less than 18 years of age.
- Participants who cannot speak English.
- Participants who are not competent to consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Deliberation With and Without Attention: Can We Enhance Informed Choices About Invasive Prenatal Testing? A Proof of Principle Study
This study will compare the effectiveness of two interventions to help women make informed choices about whether or not to undergo an invasive procedure (amniocentesis or chorionic villus sampling) for prenatal testing. The interventions are: 1) conscious deliberation (getting women to focus on and engage in the decision) and 2) unconscious deliberation (getting women not to focus on the decision). Studies suggest that some women are ambivalent about their decisions regarding invasive prenatal testing and those with the most ambivalence experience greater conflict about the decision. Techniques to reduce ambivalence through conscious or unconscious deliberation might lead to better informed choices. The two methods will also be compared with standard counseling for prenatal testing decisions.
Women 18 years of age or older who are referred for prenatal genetic counseling to consider invasive prenatal testing and who have not previously undergone prenatal testing may be eligible for this study.
Read more
Participants complete a questionnaire before and after receiving standard genetic counseling. They are then randomly assigned to one of three study groups:
- Standard genetic counseling (control group): Receives no further intervention beyond standard counseling.
- Conscious deliberation: Participants complete a form that focuses their attention on the pros and cons of invasive prenatal testing. This is followed by a brief questionnaire to evaluate time spent thinking about the session and the ease of completing the session.
- Unconscious deliberation: Participants are provided a distraction task to complete during the session, such as a word or number puzzle and are told they will be asked about their decision regarding invasive prenatal testing at the end of the session. This is followed by a brief questionnaire to evaluate time spent thinking about the session and the ease of completing the session.
Participants are contacted by telephone 1 month after the counseling session to find out what they decided regarding invasive prenatal testing and to assess any conflict they experienced about the decision.
...
Read the detailed description
This study will compare the efficacy of two interventions aimed at facilitating informed choice about invasive prenatal testing: a) deliberation with attention and b) deliberation without attention. Deliberation with attention is conscious engagement and deliberation without attention is aimed at facilitating unconscious engagement. These will be compared with standard counseling for prenatal testing decisions. As a proof of principle study, the overall study goal is to demonstrate that the interventions have the desired effect on the variables hypothesized to be proximal to the primary endpoint. In this case, we aim to demonstrate an effect for both interventions on the outcome of value-behavior consistency and to determine effect sizes for estimating the sample size needed for a clinical trial.
- Conditions
- Pregnancy - Prenatal Testing
- Keywords
- Prenatal Testing, Test Decision-Making, Decision-Making Intervention, Theory of Unconscious Thought, Informed Choice, Decision Making, Counseling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study start7 Aug 2007
- Study completion31 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy - Prenatal TestingStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514553
- Sponsor's protocol ID
- 070204
- Other IDs
- 07-HG-0204
- Status last verified
- 31 May 2011
- First submitted
- 9 Aug 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
O'Connor AM, Jacobsen MJ, Stacey D. An evidence-based approach to managing women's decisional conflict. J Obstet Gynecol Neonatal Nurs. 2002 Sep-Oct;31(5):570-81. doi: 10.1111/j.1552-6909.2002.tb00083.x.
PubMed 12353737Bekker HL, Hewison J, Thornton JG. Understanding why decision aids work: linking process with outcome. Patient Educ Couns. 2003 Jul;50(3):323-9. doi: 10.1016/s0738-3991(03)00056-9.
PubMed 12900106Wilson TD, Schooler JW. Thinking too much: introspection can reduce the quality of preferences and decisions. J Pers Soc Psychol. 1991 Feb;60(2):181-92. doi: 10.1037//0022-3514.60.2.181.
PubMed 2016668
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deliberation With and Without Attention: Can We Enhance Informed Choices About Invasive Prenatal Testing? A Proof of Principle Study
- ClinicalTrials.gov ID
- NCT00514553
- Acronym / sponsor ID
- 070204
- Conditions
- Pregnancy - Prenatal Testing
- Keywords
- Prenatal Testing, Test Decision-Making, Decision-Making Intervention, Theory of Unconscious Thought, Informed Choice, Decision Making, Counseling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 7 Aug 2007
- Study completion
- 31 May 2011
- First posted
- 10 Aug 2007 (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.
This study will compare the effectiveness of two interventions to help women make informed choices about whether or not to undergo an invasive procedure (amniocentesis or chorionic villus sampling) for prenatal testing. The interventions are: 1) conscious deliberation (getting women to focus on and engage in the decision) and 2) unconscious deliberation (getting women not to focus on the decision). Studies suggest that some women are ambivalent about their decisions regarding invasive prenatal testing and those with the most ambivalence experience greater conflict about the decision. Techniques to reduce ambivalence through conscious or unconscious deliberation might lead to better informed choices. The two methods will also be compared with standard counseling for prenatal testing decisions.
Women 18 years of age or older who are referred for prenatal genetic counseling to consider invasive prenatal testing and who have not previously undergone prenatal testing may be eligible for this study.
Participants complete a questionnaire before and after receiving standard genetic counseling. They are then randomly assigned to one of three study groups:
- Standard genetic counseling (control group): Receives no further intervention beyond standard counseling.
- Conscious deliberation: Participants complete a form that focuses their attention on the pros and cons of invasive prenatal testing. This is followed by a brief questionnaire to evaluate time spent thinking about the session and the ease of completing the session.
- Unconscious deliberation: Participants are provided a distraction task to complete during the session, such as a word or number puzzle and are told they will be asked about their decision regarding invasive prenatal testing at the end of the session. This is followed by a brief questionnaire to evaluate time spent thinking about the session and the ease of completing the session.
Participants are contacted by telephone 1 month after the counseling session to find out what they decided regarding invasive prenatal testing and to assess any conflict they experienced about the decision.
...
Detailed description
This study will compare the efficacy of two interventions aimed at facilitating informed choice about invasive prenatal testing: a) deliberation with attention and b) deliberation without attention. Deliberation with attention is conscious engagement and deliberation without attention is aimed at facilitating unconscious engagement. These will be compared with standard counseling for prenatal testing decisions. As a proof of principle study, the overall study goal is to demonstrate that the interventions have the desired effect on the variables hypothesized to be proximal to the primary endpoint. In this case, we aim to demonstrate an effect for both interventions on the outcome of value-behavior consistency and to determine effect sizes for estimating the sample size needed for a clinical trial.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women referred for prenatal genetic counseling to consider invasive prenatal testing who have not previously undergone prenatal testing.
- Women who are ambivalent about undergoing prenatal testing. They will be screened for ambivalence by answering no to a question about whether they have decided to undergo prenatal testing and yes to a close-ended question about whether you have mixed or conflicting feelings toward undergoing testing.
- Women must be greater than or equal to 18 years old.
- Participants must speak English
- Participants must be competent to consent to participate in the study.
Key exclusion criteria (4 listed)
- Men
- Participants less than 18 years of age.
- Participants who cannot speak English.
- Participants who are not competent to consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 12353737O'Connor AM, Jacobsen MJ, Stacey D. An evidence-based approach to managing women's decisional conflict. J Obstet Gynecol Neonatal Nurs. 2002 Sep-Oct;31(5):570-81. doi: 10.1111/j.1552-6909.2002.tb00083.x.
- Background: PubMed 12900106Bekker HL, Hewison J, Thornton JG. Understanding why decision aids work: linking process with outcome. Patient Educ Couns. 2003 Jul;50(3):323-9. doi: 10.1016/s0738-3991(03)00056-9.
- Background: PubMed 2016668Wilson TD, Schooler JW. Thinking too much: introspection can reduce the quality of preferences and decisions. J Pers Soc Psychol. 1991 Feb;60(2):181-92. doi: 10.1037//0022-3514.60.2.181.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy - Prenatal Testing, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
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 5 inclusion and 4 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514553, which also lists 3 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 2 Jul 2017.