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| Descriptive Information Fields | |||||||||
| Brief Title † | Reducing Health Risk Behavior and Improving Health in Adolescents With Depression | ||||||||
| Official Title † | Reducing Health Risk Behavior and Improving Health in Adolescent Depression | ||||||||
| Brief Summary | This study will determine the effectiveness of a health education intervention in reducing health risk behavior and improving health in adolescents with depression. |
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| Detailed Description | Depression is a common disorder among adolescents. If left untreated, it can cause significant disability, illness, and even death. Teens with depression often engage in risky health behaviors, such as smoking, drug and alcohol use, unprotected sex, and unhealthy eating and exercise patterns. By reducing these health risk behaviors, depressed adolescents may be able to avoid negative health consequences and improve their physical and mental health. This study will determine the effectiveness of a health education intervention in reducing risky health behaviors in adolescents with depression. Participants in this study will be invited to enroll during a visit to a participating primary care clinic. Participants will be randomly assigned to either partake in a health education intervention or receive standard care. Both groups will continue to receive treatment through their primary care clinic. Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors. Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention. The intervention will be tailored to target the specific risky behaviors in which each participant engages. Motivational interviewing will also be used to build positive attitudes to support behavior change. All participants will attend follow-up visits to assess behavior change at Months 6 and 12 following study entry. |
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| Study Phase | Phase I, Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Composite health risk behavior score [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Composite International Diagnostic Interview (CIDI) depression diagnosis [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ] Satisfaction with care, as measured by the SF-12 health survey [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ] |
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| Condition † | Depression Adolescent Health |
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| Intervention † | Other: Treatment as usual Behavioral: Behavioral health intervention |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 350 | ||||||||
| Start Date † | October 2007 | ||||||||
| Completion Date | April 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00461539 | ||||||||
| Organization ID | R01 MH78596 | ||||||||
| Secondary IDs †† | DAHBR 96-BHB | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | April 16, 2007 | ||||||||
| Last Updated Date | March 4, 2008 | ||||||||
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