Internet-based Treatment of Early Childhood Fecal Incontinence

Not Applicable

Completed

• Conditions: Encopresis
• Interventions: Behavioral: Internet-based intervention UCanPoopToo; Behavioral: treatment as usual

• Registration Number: NCT00067769
• Lead Sponsor: University of Virginia

Brief Summary

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.

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 Timeline

• Study First Submitted: 2003-08-27
• Study First Submitted QC: 2003-08-27
• Study First Posted: 2003-08-28
• Study Start: 2003-10
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2014-06
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU+UCanPoopToo	Internet-based intervention UCanPoopToo	Patients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)
TAU	treatment as usual	Patients received treatment as usual (TAU) as defined as continued clinical care.

Primary Outcome Measures

Name	Time	Method
Fecal accident outcomes with online diary data	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	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.

Secondary Outcome Measures

Name	Time	Method
Fecal accident outcomes with retrospective data	Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)	Number of accidents per 2 week period
Parent knowledge of encopresis	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).
Encopresis Cost Analysis	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.
Virginia Encopresis Constipation Apperception Test (VECAT)	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.

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States