Concurrent Treatment for Depressed Parents and DepressedAdolescents
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| First Received Date ICMJE | August 3, 2009 | ||||||||
| Last Updated Date | July 28, 2012 | ||||||||
| Start Date ICMJE | July 2009 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Depression [ Time Frame: Measured at baseline, post-treatment, and after 12 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00951821 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Suicidal ideation and behavior [ Time Frame: Measured at baseline, post-treatment, and after 12 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Concurrent Treatment for Depressed Parents and DepressedAdolescents | ||||||||
| Official Title ICMJE | Concurrent Treatment for Parents and Adolescents Who Attempt Suicide | ||||||||
| Brief Summary | This study will develop an integrated treatment for adolescents who are depressed and suicidal and their parents who are depressed and have a history of suicidality. |
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| Detailed Description | Depression, like many psychiatric disorders, has a genetic component that makes it more likely that members of the same family will have the disorder. Depression in parents, particularly mothers, may put the children at greater risk for depression. When an adolescent whose parent is depressed develops depression himself or herself, treating both the parent and the adolescent may be more effective than treating only the adolescent. This study will test a depression treatment that targets depressed suicidal adolescents with a parent or primary caretaker who is also depressed and has a history of suicidality. Participation in this study will last 6 months. Participants will be randomly assigned to receive either concurrent parent and adolescent treatment or adolescent only treatment. For those assigned to concurrent treatment, both the adolescent participants and one of their parents will receive individual cognitive behavioral therapy (CBT) counseling sessions and joint family counseling sessions. In the adolescent only treatment condition, adolescent participants will receive individual CBT sessions, but parents will not, and both will receive joint family sessions. Counseling sessions will last 1 hour and occur weekly for 3 months, and then every other week for 3 months. CBT identifies and attempts to change problematic thought patterns. All participants will receive medication consultation if necessary. Participants will complete assessments at baseline, post-treatment, and 6 months after completing treatment. These assessments will include questionnaires and interviews about depression, suicidal thoughts, mood regulation, behavioral problems, and family. At post-treatment and the 6-month follow-up, participants will also be asked to give feedback about the counseling, medication consultation, and their satisfaction. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | March 2013 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Adolescents:
Inclusion Criteria for Primary Caretakers:
Exclusion Criteria for Adolescents:
Exclusion Criteria for Primary Caretakers:
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| Gender | Both | ||||||||
| Ages | 12 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00951821 | ||||||||
| Other Study ID Numbers ICMJE | R34 MH082211, R34 MH 082211, DSIR 84 CTS | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Anthony Spirito, PhD, National Institute of Mental Health (NIMH) | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | July 2012 | ||||||||
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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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