Protocol Number: 07-HG-0204

Title:

Deliberation with and without Attention: Can We Enhance Informed Choices about Invasive Prenatal Testing? A Proof of Principle Study

Number:

07-HG-0204

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. 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.

Sponsoring Institute:

National Human Genome Research Institute (NHGRI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria:

INCLUSION CRITERIA:

-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.

EXCLUSION CRITERIA:

-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.

Special Instructions:

Currently Not Provided

Keywords:

Prenatal Testing

Test Decision-Making

Decision-Making Intervention

Theory of Unconscious Thought

Informed Choice

Recruitment Keyword(s):

Decision Making

Informed Choice

Counseling

Condition(s):

Pregnancy - Prenatal Testing

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Human Genome Research Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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.

Bekker HL, Hewison J, Thornton JG. Understanding why decision aids work: linking process with outcome. Patient Educ Couns. 2003 Jul;50(3):323-9.

Wilson 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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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