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Preventing Youth Suicide in Primary Care: A Family Model
This study is currently recruiting participants.
Verified by Children's Hospital of Philadelphia, January 2008
Sponsored by: Children's Hospital of Philadelphia
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00604097
  Purpose

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

MedlinePlus related topics: Depression Suicide
U.S. FDA Resources
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

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Suicidal Ideation Questionnaire - JR (SIQ-JR) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

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
2: Active Comparator
Enhanced Usual Care
Behavioral: Enhanced Usual Care
Rapid referral to community outpatient care with weekly monitoring of symptoms by study team

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Suicidal ideation (SIQ-JR > 30)
  • Moderate depressed mood (BDI-II > 19)
  • At least one parent/caregiver willing to participate

Exclusion Criteria:

  • Psychosis
  • Mental retardation or other significant cognitive impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604097

Contacts
Contact: Matthew B Wintersteen, PhD 215-590-7565 wintersteen@email.chop.edu

Locations
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
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Guy S Diamond, PhD Children's Hospital of Philadelphia
  More Information

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

Keywords provided by Children's Hospital of Philadelphia:
youth suicide
family therapy
primary care
intervention

Study placed in the following topic categories:
Suicide
Behavioral Symptoms
Self-Injurious Behavior

ClinicalTrials.gov processed this record on January 14, 2009