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Internet-Based Treatment of Early Childhood Fecal Incontinence
This study is ongoing, but not recruiting participants.
Study NCT00067769   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: August 27, 2003   Last Updated: January 19, 2007   History of Changes

August 27, 2003
January 19, 2007
October 2003
 
Number of episodes of fecal soiling
Same as current
Complete list of historical versions of study NCT00067769 on ClinicalTrials.gov Archive Site
Trips to the toilet
Same as current
 
Internet-Based Treatment of Early Childhood Fecal Incontinence
Treatment of Early Childhood Constipation/Encopresis

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Encopresis
Behavioral: Internet-based intervention for Enhanced Toilet Training
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
September 2007
 

Inclusion Criteria

  • Child seen by pediatrician, family physician, or psychologist for the treatment of encopresis
  • Access to the Internet, either through a family computer or a community computer

Exclusion Criteria

  • Diagnosis of either mental retardation (IQ < 85) or a primary illness responsible for fecal soiling (e.g., spina bifida)
Both
6 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067769
 
2R01 HD28160-12
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Daniel J Cox, PhD University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP