Internet Intervention for Childhood Encopresis
Condition: Encopresis
MeSH terms: Fecal Incontinence; Encopresis
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of an Internet intervention designed to reduce the
      behaviors and symptoms of pediatric encopresis.
    

Detailed description: 
      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.
    

Intervention name(s): Internet Intervention + Stepped Care; Internet Intervention; Patient Education Website
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will spend about 1 hour each week for 6 weeks using the Internet Intervention. In the first week, users will complete tutorials covering the three main components of treatment: 1) anatomy, physiology and pathophysiology of digestion; 2) education on clean-out and laxative treatments; and 3) behavioral treatment for encopresis. In subsequent weeks, users will complete weekly "follow-ups," where they answer a series of questions about their progress and needs. The program then assigns additional intervention modules based on the difficulties the participants endorses. The 22 modules target a variety of issues including fears of toilet use; social isolation; administering, adjusting, and tapering laxatives; diet; hygiene; and preventing relapses. In addition to automatic emails, participants in this group will also receive additional support based on whether they complete specific intervention milestones.; As described in Arm 1 above, participants will spend about 1 hour each week for 6 weeks using the Internet intervention. In the first week, users will complete tutorials covering the three main components of treatment: 1) anatomy, physiology and pathophysiology of digestion; 2) education on clean-out and laxative treatments; and 3) behavioral treatment for encopresis. In subsequent weeks, users will complete weekly "follow-ups," where they answer a series of questions about their progress and needs. The program will then assign additional intervention modules based on the difficulties the participant endorses. The 22 modules target a variety of issues including fears of toilet use; social isolation; administering, adjusting, and tapering laxatives; diet; hygiene; and preventing relapses.; Participants will be given access to a relevant patient education website. It will contain material on managing and treating the behaviors and symptoms of childhood encopresis.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment