Informed Choice Regarding Invasive Prenatal Testing
Condition: Pregnancy - Prenatal Testing
Study type: Observational

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.

      ...
    

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.
    

Time perspective: Prospective
Keywords: Prenatal Testing; Test Decision-Making; Decision-Making Intervention; Theory of Unconscious Thought; Informed Choice; Decision Making; Counseling