Internet-based Treatment of Early Childhood Fecal Incontinence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00067769
First received: August 27, 2003
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Encopresis
Behavioral: Internet-based intervention for Enhanced Toilet Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Early Childhood Constipation/Encopresis

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Number of episodes of fecal soiling

Secondary Outcome Measures:
  • Trips to the toilet

Estimated Enrollment: 100
Study Start Date: October 2003
Estimated Study Completion Date: September 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067769

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22902
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Daniel J Cox, PhD University of Virginia
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00067769     History of Changes
Other Study ID Numbers: 11116, 5R01HD028160-12
Study First Received: August 27, 2003
Last Updated: January 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Virginia:
Encopresis
Internet
Web
Treatment
Intervention

Additional relevant MeSH terms:
Encopresis
Fecal Incontinence
Signs and Symptoms, Digestive
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014