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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 19, 2009 | ||||||||
| Last Updated Date | June 25, 2009 | ||||||||
| Start Date ICMJE | November 2004 | ||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Negative cognitions [ Time Frame: Measured at baseline, after 1 month of treatment, and at post-treatment ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00904917 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Preventing Depression in the Children of Depressed African American Mothers | ||||||||
| Official Title ICMJE | Children of Depressed Mothers: Culture & Prevention | ||||||||
| Brief Summary | This study will test a program for preventing depression from developing in the children of depressed African American mothers. |
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| Detailed Description | The children of depressed women are at an increased risk of developing depression, in addition to other psychological disorders. Studies show that this effect may occur cross culturally, and studies of African American mothers with depression show that their parenting is limited in structure and involvement. Depression may be transmitted from parent to child through exposure to the depressed parent's negative cognitions, behaviors, and affect and through stressors of daily life that accompany living with a depressed person. Previous studies of depression prevention programs for the children of depressed mothers have proved effective in changing negative behaviors and attitudes. This study will test a depression prevention program modified to treat the children of depressed, African American mothers. Participation in this study will last 2 months. Participants will be randomly assigned to receive either an eight-session family-based prevention program or a two-session education control program. Both programs will involve the 8- to 14-year-old child of a depressed African American mother and any other adult family members who want to be involved. Participants in the family-based prevention program and their families will meet weekly with a study therapist to learn about depression, its impact on the family, coping with life stresses, and thinking skills. Although the treatment always will have the same core elements, it will be tailored to meet the clinical and cultural needs of each family. The education program will involve two meetings, one 4 weeks and one 6 weeks after enrollment, with a study researcher. Participants and their families in the education program will only receive information on depression and its impact on the family. Participants will complete assessments at baseline, after 1 month of treatment, and post-treatment. These assessments will include interviews and questionnaires for both children and adults about family functioning, environment, and the child. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Depression | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Mothers:
Inclusion Criteria for Children:
Exclusion Criteria for Mothers:
Exclusion Criteria for Children:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00904917 | ||||||||
| Responsible Party | Rhonda C. Boyd, The Children's Hospital of Philadelphia | ||||||||
| Study ID Numbers ICMJE | K01 MH068619, DSIR 8K-RTCT, IRB NO: 2004-10-4041 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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