- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01012180
Parents With Bipolar Disorder: Relationship of Adaptation to Own Illness With Risk Perception and Coping With Perceived Risk to a Child
April 4, 2018 updated by: National Human Genome Research Institute (NHGRI)
Background:
- Bipolar disorder is a common mood disorder that affects 1% to 2% of the population. Individuals with bipolar disorder tend to have periods of mania that are characterized by extra energy, very poor judgment or unrealistic beliefs about their thoughts and abilities, and an inability to complete thoughts and tasks; as well as major depressive episodes. The range and frequency of symptoms in affected individuals can vary greatly. Most individuals have cyclical symptoms and spend more time in a normal mood state than in an overtly symptomatic state.
- Relatives of individuals with bipolar disorder have an increased risk for bipolar disorder and other mood disorders. Currently, risk assessment for recurrence of a mood disorder is based on family and medical histories; genetic testing has not proved particularly useful to date for assessing risks of a mood disorder.
- Despite its prevalence, there is limited research on coping with bipolar illness. No published studies have examined adaptation to living with bipolar disorder or risk for bipolar disorder. More specifically, though a positive family history is the most important known risk factor for bipolar disorder, there are no published studies about response to the threat of future illness onset in children, risk modification efforts undertaken by affected parents, or coping with the risk for illness in children.
Objectives:
- To examine parents appraisals of the impact and cause of bipolar disorder, and the association with their perceived risk for bipolar illness in their child and how they cope with their perception of risk to their child.
- To assess whether parents adaptation to their own illness is associated with coping with perceived risk to their child.
- To describe parents coping strategies related to perceived risk in their children.
Eligibility:
- Men and women at least 18 years of age who have been diagnosed with bipolar disorder and who have at least one biological child (30 years of age or younger). Participants must be a primary caregiver for their children.
Design:
- Participants in this study will take an online survey and answer questions about disease perceptions, coping strategies, and adapting to a diagnosis of bipolar disorder, addressing issues such as the following:
- Assessing the threat of bipolar disorder and coping with one s own illness.
- Optimism/pessimism of the individual coping with the illness.
- Perception of risk to a child, and coping with the perceived risk.
- Data from this study will not be shared with the participants/respondents.
Study Overview
Status
Completed
Conditions
Detailed Description
Though psychiatric disorders are extremely common and individuals with bipolar disorder have reproductive fitness approaching population rates, we know very little about the perceptions and coping of parents with bipolar disorder related to their at-risk children.
Bipolar disorder is an etiologically-complex psychiatric disorder that is caused by a combination of genetic and environmental risk factors.
This study proposes to assess perceptions of parents with bipolar disorder about their illness, response to illness threat, and concerns about their children s risks.
We then propose to assess whether those appraisals are associated with the outcomes of coping strategies and adaption.
As informed by the Transactional Theory of Stress and Coping, we propose to use a web-based survey to examine disease perceptions, coping strategies, and adaptation to the disorder.
Respondents will be recruited through the National Alliance of the Mentally Ill (NAMI).
The study is cross-sectional and the survey is composed of several valid and reliable scales to measure the constructs predicted to be involved in adaptation.
Open-ended questions are included to help interpret results from the measures.
Knowledge about parents perceptions and coping with their own illness and with risk to children may lead to studies of potential coping interventions.
Ultimately, downstream studies may help to improve parents adaptation to their own condition and how successfully they are able to manage concerns about perceived risks to their child.
Study Type
Observational
Enrollment (Actual)
266
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
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Bethesda, Maryland, United States
- NAMI Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- INCLUSION CRITERIA:
- Have a diagnosis of bipolar disorder
- Be 18 years or older
- Be a biological parent of a child who is younger than 30 years old
- Be willing to participate in the survey
- The participant must be (or must have been) the primary caretaker for his or her child.
EXCLUSION CRITERIA:
- A participant must meet inclusion criteria.
- A participant s child cannot have been diagnosed with a mood disorder or other serious psychiatric disorder.
- A participant s child cannot have been adopted.
- The participant s child cannot be 30 years of age or older.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adaptation to bipolar disorder.
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Secondary Outcome Measures
Outcome Measure |
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Coping with perceived risk of bipolar to ones children.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
- Austin JC, Smith GN, Honer WG. The genomic era and perceptions of psychotic disorders: genetic risk estimation, associations with reproductive decisions and views about predictive testing. Am J Med Genet B Neuropsychiatr Genet. 2006 Dec 5;141B(8):926-8. doi: 10.1002/ajmg.b.30372.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 23, 2009
Study Completion
June 7, 2013
Study Registration Dates
First Submitted
November 10, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (Estimate)
November 11, 2009
Study Record Updates
Last Update Posted (Actual)
April 5, 2018
Last Update Submitted That Met QC Criteria
April 4, 2018
Last Verified
June 7, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999910007
- 10-HG-N007
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.
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