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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


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
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