Clinical trial NCT00604097: Preventing Youth Suicide in Primary Care: A Family Model
Official title: Preventing Youth Suicide in Primary Care: A Family Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Suicide
Keywords: youth suicide
family therapy
primary care
intervention
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2008-01-29
Enrollment: 66
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Suicidal Ideation Questionnaire - JR (SIQ-JR)
timeFrame: Baseline, 6 weeks, 12 weels, 24 weeks
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Scale for Suicidal Ideation (SSI)
timeFrame: baseline, 6 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Treatment retention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: CHOP Adolescent Care Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP University City Primary Care
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care Center at Cobb's Creek
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care Center in South Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Guy S Diamond, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2012 Jun 18.
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. doi: 10.1097/00004583-201002000-00006.