Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | July 8, 2008 | ||||||||||||||||
| Last Updated Date | November 21, 2011 | ||||||||||||||||
| Start Date ICMJE | August 2008 | ||||||||||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00714818 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness | ||||||||||||||||
| Official Title ICMJE | Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma. | ||||||||||||||||
| Brief Summary | Women with a close relative who has experienced mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder often have a poor understanding of the causes of the illness, and are often very worried about the chance that any children that they have will become affected with the same illness. Often, because of this fear, these healthy women choose not to have children. Genetic counseling is a process where information about the causes of illnesses, and about chances for family members of individuals with these illnesses to become similarly affected is provided in a supportive environment by a specially trained healthcare professional. This study will investigate whether genetic counseling can reduce perceptions of risk and stigma, and increase perceived control and knowledge about the causes of the illness, amongst women who have a first degree relative with a major mental illness. |
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| Detailed Description | We will recruit 75 women who have a close relative with a major psychiatric disorder (as defined above). Each participant will be randomized into one of 3 groups of approximately equal size: one of which will receive genetic counseling within 1 month after enrollment (GC), another will receive the educational brochure within 1 month (EB), and the last will be assigned to waitlist (WT). After randomization (but prior to intervention for GC and EB groups, and within 1 month after enrollment for the WT group) we will gather baseline information regarding the 4 outcome measures (perceived risk and control, stigma, and knowledge). We will re-assess the 4 outcome measures immediately post-intervention for GC and EB groups. A further follow-up (for all groups) will be conducted two months after enrollment (which is 1 month post intervention for GC and EB groups). |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Phase 3 | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 13 | ||||||||||||||||
| Completion Date | November 2011 | ||||||||||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||||||||||||||
| Ages | 19 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00714818 | ||||||||||||||||
| Other Study ID Numbers ICMJE | H07-02706 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | University of British Columbia | ||||||||||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||||||||||
| Verification Date | November 2011 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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