- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00047905
Pilot Study of the Process of Prenatal Genetic Counseling
The Process of Prenatal Genetic Counseling Using a Simulated Client - A Pilot Study
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 client's 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Human Genome Research Institute (NHGRI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Any master's trained genetic counselors attending the 2002 regional meetings and/or a national meeting of the National Society of Genetic Counselors who currently provide prenatal genetic counseling services as part of their professional practices will be included in the study. In addition, any prenatal genetic counselors referred by these individuals, but who did not attend these meetings, will also be eligible to participate.
EXCLUSION CRITERIA:
Genetic counselors who do not practice prenatal counseling training programs will be excluded In addition, master's level students currently in genetic counseling training programs will be excluded from the study because differences in their stages of training and practice development would introduce additional variability into the data set.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Bernhardt BA, Biesecker BB, Mastromarino CL. Goals, benefits, and outcomes of genetic counseling: client and genetic counselor assessment. Am J Med Genet. 2000 Sep 18;94(3):189-97. doi: 10.1002/1096-8628(20000918)94:33.0.co;2-e.
- Biesecker BB, Peters KF. Process studies in genetic counseling: peering into the black box. Am J Med Genet. 2001 Fall;106(3):191-8. doi: 10.1002/ajmg.10004.
- Bernhardt BA, Geller G, Doksum T, Larson SM, Roter D, Holtzman NA. Prenatal genetic testing: content of discussions between obstetric providers and pregnant women. Obstet Gynecol. 1998 May;91(5 Pt 1):648-55. doi: 10.1016/s0029-7844(98)00011-8.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 030009
- 03-HG-0009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Genetic Counseling
-
University of California, San FranciscoNational Cancer Institute (NCI); National Institutes of Health (NIH); University...CompletedGenetic CounselingUnited States
-
National Human Genome Research Institute (NHGRI)CompletedGenetic Counseling | AdoptionUnited States
-
Instituto Nacional de Ciencias Medicas y Nutricion...CompletedHereditary Cancer | Genetic CounselingMexico
-
Erin RothwellNational Human Genome Research Institute (NHGRI)RecruitingPregnancy | Shared Decision Making | Genetic Testing | Genetic Counseling | Prenatal DisorderUnited States
-
Hospital Clinic of BarcelonaCompletedGenetic Counseling | Prenatal DiagnosisSpain
-
National Human Genome Research Institute (NHGRI)CompletedGenetic Counseling | Moral Value Conflicts | Moral DistressUnited States
-
Stanford UniversityCompletedGenetic Counseling ProfessionUnited States
-
Central Hospital, Nancy, FranceCompletedGenetic Disease | CNV | Genetic Counseling | Array CGHFrance
-
Hospital Universitario La FeUnknownCancer | Psychological Distress | Hereditary Diseases | Genetic CounselingSpain
Clinical Trials on examine the process of prenatal genetic counseling
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletedAnxiety | Knowledge, Attitudes, Practice | Decision Making | Chromosome AbnormalityTurkey
-
Assistance Publique Hopitaux De MarseilleCompleted
-
AOSpine North America Research NetworkAOSpine North AmericaCompletedMetastatic Epidural Spinal Cord CompressionUnited States, Canada
-
Northwestern UniversityGeorgetown UniversityRecruitingChronic Kidney Diseases | Kidney Transplantation | Apolipoprotein L1United States
-
Nanfang Hospital, Southern Medical UniversityRecruitingDecompensated Cirrhosis | Overt Hepatic Encephalopathy | CMV ReactivationChina
-
Erin RothwellNational Human Genome Research Institute (NHGRI)RecruitingPregnancy | Shared Decision Making | Genetic Testing | Genetic Counseling | Prenatal DisorderUnited States
-
University of VirginiaCompleted
-
T.C. ORDU ÜNİVERSİTESİCompletedHealth PersonnelTurkey
-
Dr. Boris ZevinCompletedCholecystectomy | Consent | LaparoscopicCanada
-
NRZ Magdeburg Median Kliniken GmbH & CoCompleted