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临床试验/NCT00043537
NCT00043537已完成3 期

Treatment of Childhood Social Phobia

University of Central Florida1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2001年4月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

Fluoxetine given in 10mg doses, up to 40 mg as tolerated

干预措施: Fluoxetine (Drug)

Pill placebo

Placebo Comparator

Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.

干预措施: Pill Placebo (Drug)

研究者

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

Deborah Beidel

Professor of Psychology

University of Central Florida

研究点 (1)

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