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| Descriptive Information Fields | |||||||||
| Brief Title † | A Clinic-Based Prevention Program for Families of Depressed Mothers | ||||||||
| Official Title † | A Clinic-Based Program for Families of Depressed Mothers | ||||||||
| Brief Summary | This study will assess the effectiveness of the "Keeping Families Strong" program (KFS) in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers. |
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| Detailed Description | Children of depressed mothers are at high risk for developing serious psychiatric disorders. While genetics can account for about 34% of cases of childhood psychiatric disorders, children of depressed parents are at an even greater risk of developing mental disorders. The "Keeping Families Strong" program, or KFS, was built from evidence-based prevention programs. Its goal is to provide educational, cognitive, and behavioral interventions. These interventions are meant to enhance understanding about depression and its effects on families, improve communication within families, enhance social support, increase positive and consistent parenting, and improve child coping. This will likely improve the children's mental health, as well as positively affect the short- and long-term outcomes of parents recovering from a depressive episode. This study will evaluate the effectiveness of the KFS program in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers. This 10-week, open-label program will involve 12 meetings, lasting 2 hours each. The parents and the children will attend separate meetings each week on the same nights. Children are prone to take on their parents' responsibilities to prevent them from becoming depressed. In order to avoid this, the children's meetings will focus on clarifying role responsibilities. There will be two additional follow-up meetings in the 3 months following completion of the program. All caregivers are encouraged to participate, including depressed fathers. |
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| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks | ||||||||
| Secondary Outcome Measure † | Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period | ||||||||
| Condition † | Depression Attention Deficit Disorder With Hyperactivity Conduct Disorder |
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| Intervention † | Behavioral: Family Functioning Intervention | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 40 | ||||||||
| Start Date † | January 2005 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 8 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00149812 | ||||||||
| Organization ID | R21 MH67861 | ||||||||
| Secondary IDs †† | DSIR 82-SECH | ||||||||
| 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 | September 2005 | ||||||||
| First Received Date † | September 6, 2005 | ||||||||
| Last Updated Date | October 29, 2007 | ||||||||
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