Internet Intervention for Childhood Encopresis

Not Applicable

Completed

• Conditions: Encopresis
• Interventions: Behavioral: Internet Intervention + Stepped Care; Behavioral: Internet Intervention; Behavioral: Patient Education Website

• Registration Number: NCT00767403
• Lead Sponsor: University of Virginia

Brief 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.

Study Timeline

• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-07
• Study Start: 2010-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-02
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Internet Intervention + Stepped Care	-
2	Internet Intervention	-
3	Patient Education Website	-

Primary Outcome Measures

Name	Time	Method
Primary encopretic symptoms (as defined by): 1. Number of episodes of fecal soiling 2. Number of bowel movements in the toilet 3. Increased trips to the bathroom (both parent and self-prompted)	Baseline, 6 weeks, 6 months, 1 year

Secondary Outcome Measures

Name	Time	Method
Behavior change around encopresis (as measured by): 1. Appropriate clean-out 2. Appropriate laxative use 3. Appropriate rectus abdominis straining 4. Toileting routine	Baseline, 6 weeks, 6 months, 1 year
Secondary encopretic symptoms (as defined by): 1. Appropriate bowel movement consistency 2. Reduced bowel-specific difficulties	Baseline, 6 weeks, 6 months, 1 year
Frequency and Severity of perianal pain	Baseline, 6 weeks, 6 months, 1 year
Costs (as measured by): 1. Time spent managing symptoms 2. Doctor visits 3. Medication usage 4. Missed school/work days 5. Diapers used 6. Therapist time in stepped-care component 7. Expenses associated with building and maintaining web program	Baseline, 6 weeks, 6 months, 1 year
Website Utilization (as measured by): 1. Time spent on website 2. Number of log-ins 3. Number of completed website Modules and Follow-Ups	Throughout Intervention (from Baseline to 1 year)

Trial Locations

Locations (1)

University of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Behavioral Health and Technology; 🇺🇸 Charlottesville, Virginia, United States