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

January 16, 2008
December 13, 2012
September 2004
May 2007   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00604097 on ClinicalTrials.gov Archive Site
Treatment retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number of treatment sessions attended.
Not Provided
Not Provided
Not Provided
 
Preventing Youth Suicide in Primary Care: A Family Model
Preventing Youth Suicide in Primary Care: A Family Model

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Suicide
  • Behavioral: Attachment-Based Family Therapy
    12-16 week family-based therapy
  • Behavioral: Enhanced Usual Care
    Rapid referral to community outpatient care with weekly monitoring of symptoms by study team
  • Experimental: 1
    Attachment-Based Family Therapy
    Intervention: Behavioral: Attachment-Based Family Therapy
  • Active Comparator: 2
    Enhanced Usual Care
    Intervention: Behavioral: Enhanced Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
August 2008
May 2007   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00604097
2004-11-3995, 1 R49 CE000428
Yes
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Guy S Diamond, PhD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP