Preventing Youth Suicide in Primary Care: A Family Model

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00604097
First received: January 16, 2008
Last updated: December 13, 2012
Last verified: December 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Scale for Suicidal Ideation (SSI) [ Time Frame: baseline, 6 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604097

Locations
United States, Pennsylvania
CHOP Adolescent Care Center
Philadelphia, Pennsylvania, United States, 19104
CHOP Primary Care Center in South Philadelphia
Philadelphia, Pennsylvania, United States, 19145
CHOP Primary Care Center at Cobb's Creek
Philadelphia, Pennsylvania, United States, 19139-3723
CHOP University City Primary Care
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

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00604097     History of Changes
Other Study ID Numbers: 2004-11-3995, 1 R49 CE000428
Study First Received: January 16, 2008
Last Updated: December 13, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 01, 2014