Viewing Study NCT00047905



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00047905
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2002-10-22

Brief Title: Pilot Study of the Process of Prenatal Genetic Counseling
Sponsor: National Human Genome Research Institute NHGRI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: The Process of Prenatal Genetic Counseling Using a Simulated Client - A Pilot Study
Status: COMPLETED
Status Verified Date: 2003-04
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 examine the process of prenatal genetic counseling to determine how various client and counselor factors affect the communication process in a counseling session The specific aims of the study are to

Provide information on prenatal genetic counselors interactions with clients for the basis of a future larger study of the genetic counseling process
Determine the average length and the range of length of prenatal genetic counselors interactions with clients when family history information has already been provided
Document on videotape the communication content and interaction dynamics of prenatal genetic counselors interacting with clients in order to
Characterize different models of prenatal genetic counseling
Determine the nature of discussions concerning cystic fibrosis carrier testing within the context of prenatal genetic counseling
Examine the impact of prenatal genetic counselors characteristics years of experience training and background age clinical setting anxiety on the communication content and interaction dynamics of sessions with clients
Examine the impact of the presence of a spouse on the communication content and interaction dynamics of prenatal genetic counseling sessions with clients
Examine the impact of client verbal emotional cues on the communication content and interaction dynamics of prenatal genetic counseling sessions

Counselors will be recruited for this study from among practicing prenatal genetic counselors at regional meetings and a national meeting of the National Society of Genetic Counselors They will perform prenatal genetic counseling sessions with actors in the roles of client and clients spouse The sessions will be videotaped and the counselor and actors will fill out questionnaires regarding the characteristics of the counselor and the session

Counselors may be contacted later to request permission to use segments of their videotaped sessions for creating a video teaching tool for counseling professionals that illustrates different ways to practice the genetic counseling
Detailed Description: The main objective of this pilot study is to provide insight into the process of prenatal genetic counseling that can both inform the practice of prenatal genetic counseling and serve as the springboard to a later more comprehensive study The research participants will all be practicing prenatal genetic counselors recruited from regional meetings and a national meeting of the National Society of Genetic Counselors Participating genetic counselors will be asked to perform a prenatal genetic counseling session with a simulated client an actor or simulated clients actor and actor posing as spouse presenting with the indication of advanced maternal age The participating genetic counselors will also be asked to address cystic fibrosis carrier testing within the course of this session This session will be videotaped In addition both the genetic counselor and simulated client will be asked to fill out questionnaires related to characteristics of the counselor and the session itself The process and content of the genetic counseling communication will be analyzed qualitatively and quantitatively using Roter Interaction Analysis System Through these analyses we hope to both describe the nature of prenatal genetic counseling communication in a relatively large sample and to determine the ways in which a variety of client and counselor factors affect the communication process itself determined through changes in the RIAS communication codes In addition we hope to provide information on the logistics of data collection in order to inform a similar larger study planned to look at the impact of communication on client outcomes

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
03-HG-0009 None None None