Preventing Youth Suicide in Primary Care: A Family Model
Primary Purpose
Suicide
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Attachment-Based Family Therapy
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Suicide focused on measuring youth suicide, family therapy, primary care, intervention
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
Sites / Locations
- CHOP Adolescent Care Center
- CHOP University City Primary Care
- CHOP Primary Care Center at Cobb's Creek
- CHOP Primary Care Center in South Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Attachment-Based Family Therapy
Enhanced Usual Care
Outcomes
Primary Outcome Measures
Suicidal Ideation Questionnaire - JR (SIQ-JR)
Beck Depression Inventory - II (BDI-II)
Scale for Suicidal Ideation (SSI)
Secondary Outcome Measures
Treatment retention
Number of treatment sessions attended.
Full Information
NCT ID
NCT00604097
First Posted
January 16, 2008
Last Updated
December 13, 2012
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00604097
Brief Title
Preventing Youth Suicide in Primary Care: A Family Model
Official Title
Preventing Youth Suicide in Primary Care: A Family Model
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
youth suicide, family therapy, primary care, intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Attachment-Based Family Therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Enhanced Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Attachment-Based Family Therapy
Intervention Description
12-16 week family-based therapy
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Rapid referral to community outpatient care with weekly monitoring of symptoms by study team
Primary Outcome Measure Information:
Title
Suicidal Ideation Questionnaire - JR (SIQ-JR)
Time Frame
Baseline, 6 weeks, 12 weels, 24 weeks
Title
Beck Depression Inventory - II (BDI-II)
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Scale for Suicidal Ideation (SSI)
Time Frame
baseline, 6 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Treatment retention
Description
Number of treatment sessions attended.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy S Diamond, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHOP Adolescent Care Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
CHOP University City Primary Care
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
CHOP Primary Care Center at Cobb's Creek
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139-3723
Country
United States
Facility Name
CHOP Primary Care Center in South Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19145
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22709259
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.
Results Reference
result
PubMed Identifier
20215934
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.
Results Reference
result
Learn more about this trial
Preventing Youth Suicide in Primary Care: A Family Model
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