Preventing Youth Suicide in Primary Care: A Family Model
| Tracking Information | |||||
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| First Received Date ICMJE | January 16, 2008 | ||||
| Last Updated Date | December 13, 2012 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00604097 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Treatment retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Number of treatment sessions attended. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preventing Youth Suicide in Primary Care: A Family Model | ||||
| Official Title ICMJE | Preventing Youth Suicide in Primary Care: A Family Model | ||||
| Brief Summary | The purpose of the study is to test the efficacy of a brief family therapy (Attachment-Based Family Therapy) for youth presenting in primary care with suicidal ideation and depressed mood. |
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| Detailed Description | Youth suicide is a serious public health problem and clinical challenge for medical and behavioral health providers, yet few preventive interventions have been tested for this population. This project addresses this deficit by testing the efficacy of a brief family therapy for adolescents presenting with serious risk for suicide in a primary care setting. Several innovations characterize the study. First, patients will be identified and treated directly in the primary care setting. Integrating behavioral health services into primary care may a) reduce burden on physicians by promoting parents as safety monitors, b) increase behavioral health treatment adherence, and c) address many underlying family problems associated with suicide. Second, to identify seriously at risk adolescents, we will assess for severe and persistent suicidal ideation and co-occurring depression. Patients will need to score above clinical cutoffs on both ideation (SIQ-JR > 31) and depression (BDI-II >20) at two consecutive appointments (generally within 3 days of each other). Third, treatment will target two of the most critical suicide risk factors: depression and family conflict. Depression is the most consistently associated risk factor for suicide and family conflict is the most common precipitant of completed suicide (20%) and non-fatal suicidal episodes (50%). Fourth, we will use Attachment Based Family Therapy (ABFT; Diamond et al., 2002) as the intervention approach, an efficacious and manualized family therapy model specifically designed for adolescent depression. ABFT has been successful in reducing suicidal ideation, hopelessness, depression, anxiety, and family conflict. Participants will be recruited from the primary care centers at The Children's Hospital of Philadelphia. Eighty-seven percent of patients are African American and 60% are girls. One hundred adolescents will be randomized to 6 to 10 weeks of either ABFT or Enhanced Usual Care (EUC). Patients will be evaluated at baseline 6, 12, 24, and 52 weeks. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Suicide | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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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 | Completed | ||||
| Enrollment ICMJE | 66 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 17 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00604097 | ||||
| Other Study ID Numbers ICMJE | 2004-11-3995, 1 R49 CE000428 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Children's Hospital of Philadelphia | ||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||
| Verification Date | December 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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