Genetic CounselingNCT00047905
Pilot Study of the Process of Prenatal Genetic Counseling
A study testing examine the process of prenatal genetic counseling in people with Genetic Counseling, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Genetic Counseling
- What is being tested?
- examine the process of prenatal genetic counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Apr 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Genetic Counseling
- Being tested
- examine the process of prenatal genetic counseling
- Keywords
- Qualitative, Communication Analysis, RIAS, Counseling Models, Videotaping, Prenatal Genetic Counselors, Counseling Process, Video Tape Study, Simulated Clients, Prenatal Genetic Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
examine the process of prenatal genetic counselingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2002 (estimated)
- Study startOct 2002
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Genetic CounselingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047905
- Sponsor's protocol ID
- 030009
- Other IDs
- 03-HG-0009
- Status last verified
- Apr 2003
- First submitted
- 22 Oct 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 10995504Biesecker 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.
PubMed 11778979Bernhardt 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.
PubMed 9572205
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Process of Prenatal Genetic Counseling Using a Simulated Client - A Pilot Study
- ClinicalTrials.gov ID
- NCT00047905
- Acronym / sponsor ID
- 030009
- Conditions
- Genetic Counseling
- Keywords
- Qualitative, Communication Analysis, RIAS, Counseling Models, Videotaping, Prenatal Genetic Counselors, Counseling Process, Video Tape Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- Oct 2002
- Study completion
- Apr 2003
- First posted
- 23 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| examine the process of prenatal genetic counseling | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 10995504Bernhardt 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.
- Background: PubMed 11778979Biesecker 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.
- Background: PubMed 9572205Bernhardt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing examine the process of prenatal genetic counseling in people with Genetic Counseling, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00047905, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.