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| Descriptive Information Fields | |||||
| Brief Title † | Family Cognitive Behavioral Therapy for Preventing Depression in Children | ||||
| Official Title † | Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder | ||||
| Brief Summary | This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression. |
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| Detailed Description | Depression is a serious condition that can affect a person's work, relationships, and quality of life. Studies have shown that children of depressed parents are at a higher risk for developing depression than those whose parents have not experienced depression. Safe and effective treatments that can help prevent children of depressed parents from becoming depressed are needed. This study will compare CBT to depression education to determine which is more effective in preventing depression in the children of depressed parents. Families will be randomly assigned to receive weekly sessions of either CBT or depression education for 12 weeks. Parents in the CBT group will be taught skills to more effectively raise their children and to better manage their depressive symptoms; their children will be taught skills to cope with the stress of their parents' depression. Families in the education group will be informed about the ways that depression can affect individuals with depression and their families. Study visits will occur at study entry and at Week 12. Several follow-up visits will occur for up to 2 years after the interventional part of the study. At each visit, a clinician will make direct observations of the depressed parent's interaction with his or her children. In addition, families will be interviewed and will complete questionnaires about the parent's depressive symptoms and family interaction. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Depression, anxiety, and disruptive behavior problems in children; measured at baseline and Week 12 Depression in parents; measured at baseline and Week 12 |
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| Secondary Outcome Measure † | Parenting skills of parents; measured at baseline and Week 12 Coping skills of children; measured at baseline and Week 12 Quality of parent-child relationship; measured at baseline and Week 12 |
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| Condition † | Depression | ||||
| Intervention † | Behavioral: Family Cognitive Behavioral Therapy (CBT) Behavioral: Depression Education |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 750 | ||||
| Start Date † | July 2004 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria for Participating Families:
Exclusion Criteria for All Participants:
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| Gender | Both | ||||
| Ages | 10 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00183482 | ||||
| Organization ID | R01 MH69940 | ||||
| Secondary IDs †† | DDTR B4-ARD | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | June 2006 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | October 23, 2007 | ||||
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