Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514553
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-08-09
Brief Title:
Informed Choice Regarding Invasive Prenatal Testing
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Deliberation With and Without Attention Can We Enhance Informed Choices About Invasive Prenatal Testing A Proof of Principle Study
Status:
COMPLETED
Status Verified Date:
2011-05-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-HG-0204 | None | None | None |