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临床试验/NCT01483391
NCT01483391已完成不适用

Early Intervention for Youth at Risk for Bipolar Disorder

University of California, Los Angeles6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
6
主要终点
Changes in symptom severity

研究概览

简要总结

Children or teens with mood swings or depression who have a parent with bipolar disorder are at high risk for developing bipolar disorder themselves. This study will test a family-based therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk children (ages 9-17). In a randomized trial, the investigators will compare two kinds of family-based treatment (one more and one less intensive) on the course of early mood symptoms and social functioning among high-risk children followed for up to 4 years. The investigators will examine the effects of family treatment on measures of neural activation using functional magnetic resonance imaging.

详细描述

Children who are at high risk for developing bipolar disorder (BD) often are showing significant mood swings or depression well before they develop the full disorder. Often, these children have one or more parents who have bipolar disorder. In addition to brief episodes of lethargic depression and mania or hypomania (periods of excessive activity), children and adolescents at risk for BD often have co-occurring disorders, such as attention deficit hyperactivity disorder, conduct disorder, substance abuse disorders, and anxiety disorders.

Early interventions may lead to better mental health by preventing BD from ever fully expressing itself. This study will test an early intervention for BD called family-focused treatment (FFT), which has been designed to help children and adolescents who are at risk for developing BD. FFT will combine education about BD with training in communication strategies and problem-solving skills. It will focus on the family, because family environmental factors are related to the course and recurrence of BD. By reducing risk factors and teaching coping skills, FFT aims to reduce the early symptoms of BD, improve functioning, and delay the onset or reduce the severity of manic episodes.

Participation in this study will last up to 4 years, although the majority of the study will occur in the first year. There are three parts. In the first part, participating children and their families will complete research interviews and questionnaires about the child's mood, behavior, beliefs, and problems. Parent participants will provide information on the family background of mood or anxiety problems. All participants will receive a thorough medical-psychiatric evaluation and be provided with pharmacotherapy (as needed) from a study psychiatrist for the first year of the study.

In the second part, participants will be randomly assigned to receive one of two treatments: FFT or enhanced care. Participants receiving FFT will complete 12 therapy sessions in which parents, children, and siblings learn how to cope with mood disorders, new ways to talk to each other, and strategies for solving family problems. FFT sessions will occur weekly for the first 8 weeks and then every other week for the next 8 weeks. Participants receiving enhanced care will have 3 weekly sessions which will involve the youth and all family members. In session 1, clinicians summarize the diagnostic assessment, introduce mood charting, and offer instructional handouts on managing mood swings. In session 2, clinicians revisit mood charting, discuss medications (if relevant), and help the child and family develop a mood management plan. In session 3, families rehearse mood regulation strategies for current family, social or academic problems. Clinicians then meet with the child individually every month for the next 3 mos. to provide support, assist with problem-solving, and troubleshoot use of the mood management plan. So, both treatments last 4 months.

In the third part of the study, participants will complete follow-up assessments every 4 months for 1 year. Assessments will include interviews and questionnaires similar to those completed in the first part of the study.

研究设计

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

入排标准

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

入选标准

  • For a child to be eligible:
  • At least one biological parent or stepparent with whom the child or adolescent lives must be willing to participate in family treatment
  • At least one biological parent has a verifiable diagnosis of bipolar disorder I or II
  • The child must have a DSM-IV diagnosis of bipolar disorder not otherwise specified or major depressive disorder (MDD)
  • If the main diagnosis is MDD, the depressive episode must have occurred within the past 2 years
  • The child must have evidence of current significant affective symptoms, as determined by a score greater than 11 on the Young Mania Rating Scale within the last week or a score greater than 29 on the Child Depression Rating Scale-Revised within the last 2 weeks
  • The family must speak English, although English need not be their first language

排除标准

  • Fully diagnosable bipolar disorder I or II
  • Diagnosis of autism or pervasive developmental disorder
  • Evidence of mental retardation, as defined by an intelligence quotient (IQ) less than 70
  • Presence of comorbid neurologic diseases such as seizure disorder
  • Substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment
  • Evidence of a life-threatening eating disorder or other medical disorder that requires emergency medical treatment
  • Currently enrolled in regular family therapy
  • Evidence of current sexual or physical abuse or domestic abuse between the adult partners

结局指标

主要结局

Changes in symptom severity

时间窗: Measured at baseline, every 4 months in year 1, and every 6 months in years 2-4

Changes in symptoms of at-risk children, as defined by depression and (hypo)mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE, the Child Depression Rating Scale, and the Young Mania Rating Scale

次要结局

  • Psychosocial functioning(Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4)
  • Delaying onset of a first (hypo)manic or mixed episode(2-4 years)
  • Mental health service use(Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David J. Miklowitz, Ph.D.

Professor of Psychiatry

University of California, Los Angeles

研究点 (6)

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