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Clinical Trial Summary

This study will evaluate the effectiveness of an Internet intervention designed to reduce the behaviors and symptoms of pediatric encopresis.


Clinical Trial Description

It is estimated that between 1.5% and 7.5% of children experience encopresis. In most children, encopresis is a complication of long-standing constipation. Encopresis is defined as the repeated passage of feces in inappropriate places at least once a month, for three months, and not induced through substances or due to a general medical condition. Typically, treatment consists of medical management alone, which focuses on diet and/or laxative therapy and has a relatively low success rate. A combination of specialized medical and behavioral interventions for encopresis (Enhanced Toilet Training) has been found to have high success rates. Unfortunately, it is not readily available because of a lack of trained professionals to deliver the treatment and the amount of time and costs spent in delivering this treatment. Internet interventions, however, may lower some of the barriers associated with traditional face-to-face treatments by removing the inconvenience of scheduling appointments, missing work/school, and traveling to and from a clinician's office. This study will evaluate whether an Internet intervention is more effective than patient education in treating pediatric encopresis. This study will also evaluate whether stepped care support is additive to the effectiveness of the Internet intervention. Stepped care will involve adding personal e-mail and phone support to help families overcome obstacles to using and implementing the intervention.

Participants are randomized to receive a patient education website, the Internet intervention alone, or the Internet intervention plus stepped care. The intervention period lasts for 6 weeks. During the intervention period, subjects assigned to the patient education website will be given content addressing treatment of encopresis. Those assigned to use the Internet intervention will review interactive tutorials tailored to the user's difficulties. The stepped care group will receive the Internet intervention as well as additional support if they fail to reach specific intervention milestones. All families will complete assessment questionnaires and daily diaries of the children's symptoms and bowel behaviors for one week at baseline, following the intervention period, and at 6 and 12 months follow-up. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00767403
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase N/A
Start date January 2010
Completion date March 2012

See also
  Status Clinical Trial Phase
Completed NCT03197922 - Treatment of Encopresis in Children With Autism Spectrum Disorders Phase 3
Completed NCT00067769 - Internet-based Treatment of Early Childhood Fecal Incontinence N/A
Completed NCT04380571 - Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence N/A
Completed NCT02354820 - Child Health Improvement Through Computer Automation of Constipation Management in Primary Care N/A
Completed NCT02383758 - An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders N/A