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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00067769 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Encopresis |
Behavioral: Internet-based intervention for Enhanced Toilet Training |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Treatment of Early Childhood Constipation/Encopresis |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | September 2007 |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22902 | |
| Principal Investigator: | Daniel J Cox, PhD | University of Virginia |
More Information
| Study ID Numbers: | 2R01 HD28160-12 |
| Study First Received: | August 27, 2003 |
| Last Updated: | January 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00067769 History of Changes |
| Health Authority: | United States: Federal Government |
|
Encopresis Internet Web Treatment Intervention |
|
Signs and Symptoms Signs and Symptoms, Digestive Mental Disorders Elimination Disorders |
Encopresis Mental Disorders Diagnosed in Childhood Behavioral Symptoms |