NCT01591564已完成不适用
Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Retention rate
研究概览
简要总结
The purpose of this study is to determine the feasibility and acceptability of an utilizing an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD).
The investigators hypothesize that retention rates will be >80%,satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD intervention will have overall improvement in SMD symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, ages 13 to 17 years, who meet criteria for severe mood dysregulation as defined by NIMH criteria.
- •Subject has an estimated IQ >70 on the Kaufman Brief Intelligence Test (KBIT-2)
- •Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form.
- •Participants must be on the same dose of any prescribed medication for 4 weeks prior to randomization.
- •Children's Global Assessment Scale (CGAS) ≤ 60
排除标准
- •Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician.
- •Subject suffers from a concomitant medical or psychiatric co-morbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment).
- •Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks).
- •Pregnant females.
- •Primary caretaker does not speak English
结局指标
主要结局
Retention rate
时间窗: 20 weeks
We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.
次要结局
- Clinical Global Impressions Scale CGI-I (SMD)(20 weeks)
研究者
Leslie Miller, M.D.
Assistant Professor
Johns Hopkins University
研究点 (2)
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