Treatment of Childhood Social Phobia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
研究概览
简要总结
This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.
详细描述
Social phobia affects 3-5 percent of children, and prevalence rises with age. Youth with social phobia fear many activities that are part of everyday life and suffer from problems such as headaches or stomachaches, panic, avoidance, general anxiety, depression, loneliness, and a very restricted range of social relationships. Recent findings indicate a new psychosocial treatment called Social Effectiveness Therapy for Children (SET-C) is effective in treating children ages 8-11, resulting in reduced emotional distress and improved social functioning. Treatment effects have been maintained for up to 6 months. This study will examine SET-C in children ages 8-15. Because available data suggest that the drug fluoxetine is a promising treatment, SET-C will be compared to fluoxetine in this trial. Durability of treatment will be monitored over a 1-year follow-up period.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of social phobia
排除标准
- •Pervasive developmental disorders (PDD)
- •Schizophrenia
- •Major Depression
- •IQ of less than 80
- •Medical conditions contraindicating use of fluoxetine
研究组 & 干预措施
Social Effectiveness Therapy for Children
Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy
干预措施: Social Effectiveness Therapy for Children (SET-C) (Behavioral)
Fluoxetine
Fluoxetine given in 10mg doses, up to 40 mg as tolerated
干预措施: Fluoxetine (Drug)
Pill placebo
Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.
干预措施: Pill Placebo (Drug)
研究者
Deborah Beidel
Professor of Psychology
University of Central Florida
