Encopresis Clinical Trial
Official title:
An Internet Intervention for Childhood Constipation and Encopresis
This study will evaluate the effectiveness of an Internet intervention designed to reduce the behaviors and symptoms of pediatric encopresis.
It is estimated that between 1.5% and 7.5% of children experience encopresis. In most
children, encopresis is a complication of long-standing constipation. Encopresis is defined
as the repeated passage of feces in inappropriate places at least once a month, for three
months, and not induced through substances or due to a general medical condition. Typically,
treatment consists of medical management alone, which focuses on diet and/or laxative
therapy and has a relatively low success rate. A combination of specialized medical and
behavioral interventions for encopresis (Enhanced Toilet Training) has been found to have
high success rates. Unfortunately, it is not readily available because of a lack of trained
professionals to deliver the treatment and the amount of time and costs spent in delivering
this treatment. Internet interventions, however, may lower some of the barriers associated
with traditional face-to-face treatments by removing the inconvenience of scheduling
appointments, missing work/school, and traveling to and from a clinician's office. This
study will evaluate whether an Internet intervention is more effective than patient
education in treating pediatric encopresis. This study will also evaluate whether stepped
care support is additive to the effectiveness of the Internet intervention. Stepped care
will involve adding personal e-mail and phone support to help families overcome obstacles to
using and implementing the intervention.
Participants are randomized to receive a patient education website, the Internet
intervention alone, or the Internet intervention plus stepped care. The intervention period
lasts for 6 weeks. During the intervention period, subjects assigned to the patient
education website will be given content addressing treatment of encopresis. Those assigned
to use the Internet intervention will review interactive tutorials tailored to the user's
difficulties. The stepped care group will receive the Internet intervention as well as
additional support if they fail to reach specific intervention milestones. All families will
complete assessment questionnaires and daily diaries of the children's symptoms and bowel
behaviors for one week at baseline, following the intervention period, and at 6 and 12
months follow-up.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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