Preventing Youth Suicide in Primary Care: A Family Model

Suicide Clinical Trial

Official title:

Preventing Youth Suicide in Primary Care: A Family Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604097
• Other study ID #: 2004-11-3995
• Secondary ID: 1R49CE000428
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2008
• Last updated: December 13, 2012
• Start date: September 2004
• Est. completion date: August 2008

Study information

• Verified date: December 2012
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Attachment-Based Family Therapy
12-16 week family-based therapy
• Enhanced Usual Care
Rapid referral to community outpatient care with weekly monitoring of symptoms by study team

Locations

Country	Name	City	State
United States	CHOP Adolescent Care Center	Philadelphia	Pennsylvania
United States	CHOP Primary Care Center at Cobb's Creek	Philadelphia	Pennsylvania
United States	CHOP Primary Care Center in South Philadelphia	Philadelphia	Pennsylvania
United States	CHOP University City Primary Care	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (2)

Diamond G, Creed T, Gillham J, Gallop R, Hamilton JL. Sexual trauma history does not moderate treatment outcome in Attachment-Based Family Therapy (ABFT) for adolescents with suicide ideation. J Fam Psychol. 2012 Aug;26(4):595-605. doi: 10.1037/a0028414. — View Citation

Diamond GS, Wintersteen MB, Brown GK, Diamond GM, Gallop R, Shelef K, Levy S. Attachment-based family therapy for adolescents with suicidal ideation: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2010 Feb;49(2):122-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Ideation Questionnaire - JR (SIQ-JR)		Baseline, 6 weeks, 12 weels, 24 weeks	No
Primary	Beck Depression Inventory - II (BDI-II)		Baseline, 6 weeks, 12 weeks, 24 weeks	No
Primary	Scale for Suicidal Ideation (SSI)		baseline, 6 weeks, 12 weeks, 24 weeks	No
Secondary	Treatment retention	Number of treatment sessions attended.	12 weeks	No