Internet-based Treatment of Early Childhood Fecal Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Early Childhood Constipation/Encopresis

Conditions
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Encopresis

Intervention / Treatment
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* Behavioral: Internet-based intervention UCanPoopToo
* Behavioral: treatment as usual


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal accident outcomes with online diary data | 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 | 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 | 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 | 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) | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Encopresis, Internet, Web, Treatment, Intervention