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Preventing Youth Suicide in Primary Care: A Family Model

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604097
First Posted: January 29, 2008
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Youth Suicide in Primary Care: A Family Model

Resource links provided by NLM:


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, 12 weels, 24 weeks ]
  • Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ]
  • Scale for Suicidal Ideation (SSI) [ Time Frame: baseline, 6 weeks, 12 weeks, 24 weeks ]

Secondary Outcome Measures:
  • Treatment retention [ Time Frame: 12 weeks ]
    Number of treatment sessions attended.


Enrollment: 66
Study Start Date: September 2004
Study Completion Date: August 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Attachment-Based Family Therapy
Behavioral: Attachment-Based Family Therapy
12-16 week family-based therapy
Active Comparator: 2
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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604097


Locations
United States, Pennsylvania
CHOP Adolescent Care Center
Philadelphia, Pennsylvania, United States, 19104
CHOP University City Primary Care
Philadelphia, Pennsylvania, United States, 19104
CHOP Primary Care Center at Cobb's Creek
Philadelphia, Pennsylvania, United States, 19139-3723
CHOP Primary Care Center in South Philadelphia
Philadelphia, Pennsylvania, United States, 19145
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Guy S Diamond, PhD Children's Hospital of Philadelphia
  More Information

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00604097     History of Changes
Other Study ID Numbers: 2004-11-3995
1R49CE000428 ( U.S. NIH Grant/Contract )
First Submitted: January 16, 2008
First Posted: January 29, 2008
Last Update Posted: December 17, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms


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