Internet-based Treatment of Early Childhood Fecal Incontinence

December 4, 2015 updated by: Daniel Cox, PhD, University of Virginia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • University of Virginia Health system

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAU
Patients received treatment as usual (TAU) as defined as continued clinical care.
Behavioral: treatment as usual
Routine clinical care.
Experimental: TAU+UCanPoopToo
Patients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)
Behavioral: Internet-based intervention UCanPoopToo
Internet-based intervention to administer Enhanced Toilet Training (ETT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal accident outcomes with online diary data
Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Number of accidents per 2 week period
Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Success and cure rates
Time Frame: 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.
Post (4-6 weeks) and one year Post after the intervention period (4-6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal accident outcomes with retrospective data
Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Number of accidents per 2 week period
Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Parent knowledge of encopresis
Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Parent knowledge of encopresis was assessed on a revised version of the Encopresis Knowledge Scale (EKS).
Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Virginia Encopresis Constipation Apperception Test (VECAT)
Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Parent assessment of child's bowel specific problems related to encopresis and constipation.
Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Encopresis Cost Analysis
Time Frame: Pre and Post (4-6 weeks)
Participants quantified items and events that occurred which contribute to the cost of encopresis such as number of diapers used, number of school days missed, number of parent trips to school, and clean-out procedures then cost estimates were applied to each.
Pre and Post (4-6 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage patterns of the Internet intervention
Time Frame: Post (4-6 weeks)
Usage (number of Cores completed; number of Follow-ups completed and Modules assigned)
Post (4-6 weeks)
Internet Intervention Utility Measure of Satisfaction
Time Frame: Post (4-6 weeks)
Parent and child rated their satisfaction with the Internet intervention using the Internet Intervention Utility Questionnaire.
Post (4-6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Daniel J Cox, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

August 27, 2003

First Submitted That Met QC Criteria

August 27, 2003

First Posted (Estimate)

August 28, 2003

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11116
  • 5R01HD028160-12 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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