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临床试验/NCT00067769
NCT00067769已完成不适用

Treatment of Early Childhood Constipation/Encopresis

University of Virginia2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2003年10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
91
试验地点
2
主要终点
Fecal accident outcomes with online diary data

研究概览

简要总结

Encopresis, also known as fecal incontinence, is the voluntary or involuntary passage of stools causing soiling of clothes by a child over 4 years of age. The purpose of this study is to evaluate an Internet intervention for the treatment of encopresis.

详细描述

An estimated 2.3% of children suffer from encopresis. Enhanced Toilet Training (ETT) is one of the most effective ways of treating this disorder. When delivered by skilled and knowledgeable clinicians, ETT is twice as effective as intensive medical management alone. Although ETT is effective in treating encopretic children, there are six major barriers to its implementation: 1) availability of a knowledgeable and skilled clinician; 2) parental acceptance of referral to a mental health professional; 3) expense of service; 4) burden of time and distance to access such specialty services; 5) child resistance to disclosure of embarrassing material; and 6) willingness of the child and parent to follow treatment recommendations. This project will circumvent these barriers by developing an interactive Internet-based ETT program. The study will then assess the feasibility of the program by determining the acceptance, function, and effectiveness of the intervention.

This project will have four phases. Phase 1 will identify optimal Internet and treatment elements as well as issues in need of experimental investigation. Phase 2 will investigate how to enhance Internet interventions. Phase 3 will evaluate the relative benefit of adding the Internet treatment to clinical services provided by clinicians in the fields of medicine and mental health. Phase 4 will investigate the relative long-term benefits of adding such an Internet-based intervention to professional care to determine its impact on symptom improvement, relapse prevention, quality of life, and its cost-effectiveness. Phase 4 will also assess to what extent the program is disseminated worldwide when made available on the Internet.

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
None

入排标准

年龄范围
6 Years 至 12 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

Fecal accident outcomes with online diary data

时间窗: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)

Number of accidents per 2 week period

Success and cure rates

时间窗: Post (4-6 weeks) and one year Post after the intervention period (4-6 weeks)

Success rate as defined by having zero or one fecal accident over a two week period. Cure rate as defined by having zero accidents over the previous two weeks.

次要结局

  • Fecal accident outcomes with retrospective data(Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks))
  • Parent knowledge of encopresis(Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks))
  • Encopresis Cost Analysis(Pre and Post (4-6 weeks))
  • Virginia Encopresis Constipation Apperception Test (VECAT)(Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks))

研究者

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

Daniel Cox, PhD

Professor, Department of Psychiatry and NB Sciences

University of Virginia

研究点 (2)

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