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Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00714818
First Posted: July 14, 2008
Last Update Posted: November 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
July 8, 2008
July 14, 2008
November 23, 2011
August 2008
November 2011   (Final data collection date for primary outcome measure)
  • knowledge [ Time Frame: immediately post intervention and 1 month post intervention ]
  • risk perception [ Time Frame: immediately post intervention and 1 month post intervention ]
  • stigma [ Time Frame: immediately post intervention and 1 month post intervention ]
  • perceived control [ Time Frame: immediately post intervention and 1 month post intervention ]
Same as current
Complete list of historical versions of study NCT00714818 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness
Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness: Impact on Knowledge, Risk Perception, Perceived Control and Internalized Stigma.

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.

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).
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
  • Schizophrenia
  • Bipolar Disorder
  • Schizoaffective Disorder
  • Behavioral: Genetic Counseling
    One face-to-face genetic counseling session of 1-2hours duration, with a board certified or board eligible genetic counselor which will involve, documentation of a detailed family history, discussion of: the contributors to mental illness pathogenesis, illness risk reduction strategies, chances for family members to develop mental illness (if required), supportive counseling around living with illness/risk of illness/managing illness vulnerability, and referral to support organizations as required
  • Behavioral: Genetic Counseling
    One educational booklet that provides information about the causes of mental illnesses, and the chances for relatives of affected individuals to develop mental illness will be provided to participants.
  • Experimental: GC
    One face-to-face genetic counseling session of 1-2hours duration, with a board certified or board eligible genetic counselor which will involve, documentation of a detailed family history, discussion of: the contributors to mental illness pathogenesis, illness risk reduction strategies, chances for family members to develop mental illness (if required), supportive counseling around living with illness/risk of illness/managing illness vulnerability, and referral to support organizations as required.
    Intervention: Behavioral: Genetic Counseling
  • Active Comparator: EB
    Educational Booklet: One educational booklet that provides information about the causes of mental illnesses, and the chances for relatives of affected individuals to develop mental illness will be provided to participants
    Intervention: Behavioral: Genetic Counseling
  • No Intervention: WT
    Waitlist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fluent in English, and
  • Have a first degree relative diagnosed with schizophrenia, bipolar, or schizoaffective disorder, and
  • Reside in BC, and be able to attend 3 study visits over 1.5 months
Sexes Eligible for Study: Female
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00714818
H07-02706
No
Not Provided
Not Provided
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Jehannine Austin, PhD, CCGC, CGC University of British Columbia
Study Director: Catriona Hippman University of British Columbia
Study Director: Erin Michalak University of British Columbia
Study Director: William Honer, MD University of British Columbia
University of British Columbia
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP