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临床试验/NCT01537419
NCT01537419已完成不适用

Attachment Based Family Therapy (ABFT) for Suicidal Adolescents

Drexel University2 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2012年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
2
主要终点
Change in the Severity of Depression Symptoms Between Intake and End of Treatment

研究概览

简要总结

This study will evaluate the efficacy of attachment based family therapy (ABFT) for treatment of suicidality in adolescents. The study will compare 16 weeks of treatment with ABFT to a control condition Family Enhanced Non-directive Supportive Therapy (FE-NST).

详细描述

Suicide is the third leading cause of death for American adolescents. Nearly one million adolescents a year attempt suicide and about 500,000 adolescents a year are admitted to psychiatric hospitals for suicide attempts or serious suicidal ideation. This leads to high emotional costs for families and financial cost for the health system. Yet, no medication, and less than 10 psychotherapy studies have focused on suicidal youth and findings are mixed. There has been a call for new and innovative approaches for depression treatment highlights the need for alternative interventions for suicidal youth as well. Attachment-Based Family Therapy (ABFT) offers a promising alternative to prior treatments. It is a manualized family therapy targeting processes associated with suicide and depression. ABFT seeks to improve the adolescent-caregiver relationship by increasing the family's capacity for discussing and negotiating affectively charged issues in the relationship. Improvements in the attachment relationship provide adolescents with improved capacity for affect regulation and the ability to use the caregiver as a source of protection and support. These strengths buffer adolescents against suicide and other risk behaviors. Four studies have demonstrated that ABFT can reduce suicidal ideation and depressive symptoms with an average effect size of .97. Unfortunately, interpretation of these studies is compromised by lack of a controlled comparison treatment. This study aims to test the efficacy of ABFT using a comparison group that controls for treatment dose, duration, therapist expertise, ecological factors, and family involvement. The study includes one year follow-up data, assessment staff blind to treatment condition and tests of the purported active ingredients of ABFT. Putative change processes will be tested including: a)adolescents' expectancies for parent availability, b) emotion regulation during parent-adolescent conflict discussions, and c) resolution of loss and abuse. To test this, Dr. Kobak, a leading adolescent attachment researcher, will use the Adult Attachment Interview and observational coding of the family interaction task to test these treatment mechanisms. If successful, the findings will provide evidence for both the efficacy and specificity of a family based treatment mechanism. The investigators will recruit and randomize 130 adolescents to 16 weeks of ABFT or Family-Enhanced Non-directive Supportive Therapy (FE-NST). Assessments will be conducted at baseline, 8, 16, 32 and 52 weeks. The primary and secondary aims assess whether ABFT reduces suicidal ideation, depression, family conflict, and future suicide attempts more effectively than control. Exploratory aims test a) whether ABFT can improve parent adolescent attachment, b) if attachment mediates outcome, and if a history of trauma, parental depression or family conflict moderate outcome. The study targets adolescents with severe and persistent suicidal ideation selected from inner city, minority youth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents between the ages of 12 and 18
  • Adolescents endorse severe suicidal ideation (SIQ-JR > 31) and moderate depression (BDI-II > 20) at two time points (1 to 3 days)
  • At least one primary parent or caregiver must participate in the assessment and treatment. This could be a biological parent, stepparent, grandparent, other relative, or a foster parent, who has at least frequent contact with the subject. When possible both parents will participate in the assessment and treatment. Legal custody is always considered (e.g., divorced parents). Having all family members present at every session is not required. Many individual meetings with the subject or the parent are planned in both treatments.

排除标准

  • Evidence of imminent risk of harm to self or others that cannot be safely treated on an outpatient basis
  • Evidence of psychotic features [as reported on the Diagnostic Interview Schedule for Children; Voice Diagnostic Interview Schedule for Children (VDISC)]
  • Evidence of suffering from severe cognitive impairment (e.g., mental retardation, severe developmental disorders) as evidenced by educational records, parental report and/or clinical impression).
  • Subjects taking antidepressant medication for depression for less than 6 weeks prior to the screening.

研究组 & 干预措施

Family-Enhanced Non-directive Supportive Therapy

Active Comparator

Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.

干预措施: Family-Enhanced Non-directive Supportive Therapy (Behavioral)

Attachment-Based Family Therapy

Experimental

Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.

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

结局指标

主要结局

Change in the Severity of Depression Symptoms Between Intake and End of Treatment

时间窗: 16 weeks (end of treatment)

Beck Depression Inventory-II. The second edition of the BDI is a widely-used, 21-item self-report instrument designed to assess the severity of depressive symptoms in adults and adolescents. The BDI-II has 21 items and takes approximately 5 minutes to complete. The scale ranges from 0 to 63, with a higher score being representative of a greater clinical magnitude of depression: a total score of 0-13 is considered minimal depression, 14-19 is mild depression, 20-28 is moderate depression, and 29-63 is severe depression.

Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment

时间窗: 16 weeks (end of treatment)

The Suicidal Ideation Questionnaire-JR is a 15-item self-report assessment. It is based on Reynolds' theoretical notion of suicidality forming a continuum ranging from thoughts of death, thoughts of wanting to be dead, general and specific suicidal plans, preparations for carrying out plans, and actual suicide attempts. The scale ranges from 0 to 90, with a score of 0 being representative of no suicidal ideation, and a score of 31 or greater indicating severe suicidal ideation.

次要结局

  • Change in the Evidence of Family Conflict Between Parent and Youth After Intervention Between Intake and End of Treatment(16 weeks (end of treatment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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