An interventional study of Internet-based intervention UCanPoopToo and treatment as usual in Encopresis, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-07.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
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.
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.
34 studies on the registry are indexed under Encopresis; 12 are open to participants now.
This study's enrollment of 91 is above the median of 64 across 26 interventional studies indexed under Encopresis.
Browse Encopresis studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Patients received treatment as usual (TAU) as defined as continued clinical care.
Behavioral: treatment as usual
Patients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)
Behavioral: Internet-based intervention UCanPoopToo
Internet-based intervention to administer Enhanced Toilet Training (ETT).
Routine clinical care.
Fecal accident outcomes with online diary data
Number of accidents per 2 week period
Time frame: 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.
Time frame: Post (4-6 weeks) and one year Post after the intervention period (4-6 weeks)
Fecal accident outcomes with retrospective data
Number of accidents per 2 week period
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Pre and Post (4-6 weeks)
Usage patterns of the Internet intervention
Usage (number of Cores completed; number of Follow-ups completed and Modules assigned)
Time frame: Post (4-6 weeks)
Internet Intervention Utility Measure of Satisfaction
Parent and child rated their satisfaction with the Internet intervention using the Internet Intervention Utility Questionnaire.
Time frame: Post (4-6 weeks)
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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