- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01012180
Parents With Bipolar Disorder: Relationship of Adaptation to Own Illness With Risk Perception and Coping With Perceived Risk to a Child
4 avril 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
266
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
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Bethesda, Maryland, États-Unis
- NAMI Research Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Adaptation to bipolar disorder.
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Mesures de résultats secondaires
Mesure des résultats |
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Coping with perceived risk of bipolar to ones children.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
23 octobre 2009
Achèvement de l'étude
7 juin 2013
Dates d'inscription aux études
Première soumission
10 novembre 2009
Première soumission répondant aux critères de contrôle qualité
10 novembre 2009
Première publication (Estimation)
11 novembre 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 avril 2018
Dernière vérification
7 juin 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 999910007
- 10-HG-N007
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .