Internet-based Treatment of Early Childhood Fecal Incontinence

University of Virginia

Status: Completed

Conditions: Encopresis

Treatments: Behavioral: treatment as usual; Behavioral: Internet-based intervention UCanPoopToo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00067769

11116

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

TAU

Active Comparator group

Description:

Patients received treatment as usual (TAU) as defined as continued clinical care.

Treatment:

Behavioral: treatment as usual

TAU+UCanPoopToo

Experimental group

Description:

Patients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)

Treatment:

Behavioral: Internet-based intervention UCanPoopToo