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临床试验/NCT00338806
NCT00338806已完成不适用

Prevention for Symptomatic Offspring of Bipolar Parents

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Children's Depression Rating Scale-Revised (CDRS-R)

研究概览

简要总结

This study will develop strategies for early detection and prevention of mood disorders and associated impairment in adolescent children of parents with bipolar disorder.

详细描述

Bipolar Disorder (BD) is a serious medical illness that causes drastic shifts in a person's mood, energy, and ability to function. BD symptoms alternate from increased energy, restlessness, and overly good mood to a lasting sad, anxious, or empty mood and feelings of hopelessness or pessimism. Research suggests that children of parents with BD are at risk for developing mood disorders because of predisposing genetic factors and stressful life events, many of which may be related to their parents' unstable clinical state. Adolescent children of parents with BD must deal simultaneously with the difficult task of negotiating their own developmental transitions, as well as living with a parent with BD. It may be possible to detect symptoms of BD or other mood disorders early in adolescence and prevent the disorder from further interfering with someone's life. This study will develop and refine strategies for early detection and primary prevention of mood disorders and associated impairment in adolescent children of parents with BD.

Participants in this single-blind study will be randomly assigned to receive either interpersonal psychotherapy with adolescents (IPT-PA) or a control intervention, educational clinical monitoring (ECM), for 12 weeks. Participants assigned to IPT-PA will attend twelve sessions. The first four sessions will last 90 minutes each, and will include both family psychoeducation and individual psychotherapy with the adolescent. The remaining sessions will be 45 minutes each, and will include only individual psychotherapy with the adolescent. Participants assigned to ECM will each be assigned to a therapist. During the initial two sessions, which will take place over 2 consecutive weeks, the therapist will focus on mood disorder psychoeducation and participants will receive related written educational material. Participants will then meet with their therapists monthly for 30-minute sessions. Symptoms and functioning will be assessed, but no assistance on building interpersonal skills will be provided. A participant may request a second session each month, but if more than two monthly sessions are required, the participant will be referred for therapy. Mood episodes and symptoms, symptom severity, and functioning will be assessed for all participants at Weeks 6 and 12 and Months 6, 12, and 18 post-treatment.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Children's Depression Rating Scale-Revised (CDRS-R)

时间窗: 18 months

CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores \> 41 indicate mild-moderate depression.

Young Mania Rating Scale (YMRS)

时间窗: 18 months

An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

K SADS-Present Version (KSADS-P)

时间窗: 18 months

A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

Children's Global Assessment Scale (C-GAS)

时间窗: 18 months

C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

次要结局

  • Attitudes Toward Treatment Questionnaire(Measured at Week 12)
  • Family History Screen(Measured at Week 1 (baseline))
  • Patient Health Questionnaire(Measured at Week 1)
  • Family Assessment Device(Measured at Week 12)
  • Social Rhythm Metric Short Form(Measured at Week 12 and Months 6, 12, and 18 post-treatment)
  • Social Adjustment Scale - Self Report for Adolescents(12 months and 18 months)
  • Treatment Credibility Scale(Measured at Week 1)
  • Emotion Regulation Questionnaire(12 months and 18 months)
  • Mood Disorder Questionnaire(Week 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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