Clinical Trials Directory

Trials / Completed

CompletedNCT00067769

Internet-based Treatment of Early Childhood Fecal Incontinence

Treatment of Early Childhood Constipation/Encopresis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
91 (actual)
Sponsor
University of Virginia · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALInternet-based intervention UCanPoopTooInternet-based intervention to administer Enhanced Toilet Training (ETT).
BEHAVIORALtreatment as usualRoutine clinical care.

Timeline

Start date
2003-10-01
Primary completion
2007-07-01
Completion
2007-07-01
First posted
2003-08-28
Last updated
2015-12-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00067769. Inclusion in this directory is not an endorsement.