NCT03299140终止不适用
Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 主要终点
- CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
研究概览
简要总结
Bipolar disorder is an early onset chronic disorder. Children of bipolar parents are at high risk of developping the same disorder and/or a psychopathology. Early intervention focused on emotion and problem solving strategies could improve their prognosis.
The main objective of this trial is to evaluate the FFT (Family Focused Therapy) efficacity. Children emotional dysregulation profile will be compared before and after this CBT intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and teenagers from 6 to 16 years-old
- •At least one biological parent with bipolar disorder
- •T-score CBCL-Total ≥ 60
- •Written informed consent
排除标准
- •Active severe thymic episode
- •Autism spectrum disorders
- •Intellectual disability
研究组 & 干预措施
Family Focused Therapy
Other
Only 1 arm
干预措施: Family Focused Therapy (Behavioral)
结局指标
主要结局
CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation
时间窗: up to 12 months
次要结局
未报告次要终点
研究者
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