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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00604097 |
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.
Condition | Intervention | Phase |
---|---|---|
Suicide |
Behavioral: Attachment-Based Family Therapy Behavioral: Enhanced Usual Care |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Preventing Youth Suicide in Primary Care: A Family Model |
Estimated Enrollment: | 100 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Attachment-Based Family Therapy
|
Behavioral: Attachment-Based Family Therapy
12-16 week family-based therapy
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2: Active Comparator
Enhanced Usual Care
|
Behavioral: Enhanced Usual Care
Rapid referral to community outpatient care with weekly monitoring of symptoms by study team
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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.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Matthew B Wintersteen, PhD | 215-590-7565 | wintersteen@email.chop.edu |
United States, Pennsylvania | |
CHOP Adolescent Care Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
CHOP Primary Care Center in South Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19145 | |
CHOP Primary Care Center at Cobb's Creek | Recruiting |
Philadelphia, Pennsylvania, United States, 19139-3723 | |
CHOP University City Primary Care | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Guy S Diamond, PhD | Children's Hospital of Philadelphia |
Responsible Party: | The Children's Hospital of Philadelphia ( Guy S. Diamond, Ph.D. ) |
Study ID Numbers: | 2004-11-3995, 1 R49 CE000428 |
Study First Received: | January 16, 2008 |
Last Updated: | January 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00604097 |
Health Authority: | United States: Federal Government |
youth suicide family therapy primary care intervention |
Suicide Behavioral Symptoms Self-Injurious Behavior |