跳至主要内容
临床试验/NCT00604097
NCT00604097已完成3 期

Preventing Youth Suicide in Primary Care: A Family Model

Children's Hospital of Philadelphia8 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2004年9月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
66
试验地点
8
主要终点
Suicidal Ideation Questionnaire - JR (SIQ-JR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Suicidal ideation (SIQ-JR > 30)
  • Moderate depressed mood (BDI-II > 19)
  • At least one parent/caregiver willing to participate

排除标准

  • Psychosis
  • Mental retardation or other significant cognitive impairment

研究组 & 干预措施

1

Experimental

Attachment-Based Family Therapy

干预措施: Attachment-Based Family Therapy (Behavioral)

2

Active Comparator

Enhanced Usual Care

干预措施: Enhanced Usual Care (Behavioral)

结局指标

主要结局

Suicidal Ideation Questionnaire - JR (SIQ-JR)

时间窗: Baseline, 6 weeks, 12 weels, 24 weeks

Beck Depression Inventory - II (BDI-II)

时间窗: Baseline, 6 weeks, 12 weeks, 24 weeks

Scale for Suicidal Ideation (SSI)

时间窗: baseline, 6 weeks, 12 weeks, 24 weeks

次要结局

  • Treatment retention(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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