Internet-based Treatment of Early Childhood Fecal Incontinence
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|ClinicalTrials.gov Identifier: NCT00067769|
Recruitment Status : Completed
First Posted : August 28, 2003
Last Update Posted : December 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Encopresis||Behavioral: Internet-based intervention UCanPoopToo Behavioral: treatment as usual||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Early Childhood Constipation/Encopresis|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Active Comparator: TAU
Patients received treatment as usual (TAU) as defined as continued clinical care.
Behavioral: treatment as usual
Routine clinical care.
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).
- Fecal accident outcomes with online diary data [ Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks) ]Number of accidents per 2 week period
- Success and cure rates [ Time Frame: Post (4-6 weeks) and one year Post after the intervention period (4-6 weeks) ]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.
- Fecal accident outcomes with retrospective data [ Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks) ]Number of accidents per 2 week period
- Parent knowledge of encopresis [ Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks) ]Parent knowledge of encopresis was assessed on a revised version of the Encopresis Knowledge Scale (EKS).
- Virginia Encopresis Constipation Apperception Test (VECAT) [ Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks) ]Parent assessment of child's bowel specific problems related to encopresis and constipation.
- Encopresis Cost Analysis [ Time Frame: Pre and Post (4-6 weeks) ]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.
- Usage patterns of the Internet intervention [ Time Frame: Post (4-6 weeks) ]Usage (number of Cores completed; number of Follow-ups completed and Modules assigned)
- Internet Intervention Utility Measure of Satisfaction [ Time Frame: Post (4-6 weeks) ]Parent and child rated their satisfaction with the Internet intervention using the Internet Intervention Utility Questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067769
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22902|
|Principal Investigator:||Daniel J Cox, PhD||University of Virginia|