Internet Intervention for Childhood Encopresis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT00767403
First received: October 3, 2008
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Encopresis
Behavioral: Internet Intervention + Stepped Care
Behavioral: Internet Intervention
Behavioral: Patient Education Website

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Internet Intervention for Childhood Constipation and Encopresis

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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) [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavior change around encopresis (as measured by): 1. Appropriate clean-out 2. Appropriate laxative use 3. Appropriate rectus abdominis straining 4. Toileting routine [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Secondary encopretic symptoms (as defined by): 1. Appropriate bowel movement consistency 2. Reduced bowel-specific difficulties [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Frequency and Severity of perianal pain [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Website Utilization (as measured by): 1. Time spent on website 2. Number of log-ins 3. Number of completed website Modules and Follow-Ups [ Time Frame: Throughout Intervention (from Baseline to 1 year) ] [ Designated as safety issue: No ]

Enrollment: 290
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Internet Intervention + Stepped Care
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.
Active Comparator: 2 Behavioral: Internet Intervention
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.
Active Comparator: 3 Behavioral: Patient Education Website
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Criteria for inclusion:

A child and his or her parent/caregiver may participate in the study if:

  • The parent/caregiver is the legal guardian of his or her child.
  • The child is between the ages of 5 and 12.
  • The child has had fecal accidents for at least the past three months.
  • The child has had at least two fecal accidents during the past two weeks.
  • The child and parent/caregiver have regular access to the Internet, either through the family computer or another readily accessible computer.

Criteria for exclusion:

A child and his or her parent/caregiver may not participate in the study if:

  • The child has had an Endorectal Pull-Through Procedure.
  • The child has a history of Short Bowel Syndrome.
  • The child has a diagnosis of a primary illness responsible for fecal soiling (e.g., Spinal Bifida, Hirschsprung's Disease).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767403

Locations
United States, Virginia
University of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Behavioral Health and Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Lee M Ritterband, PhD University of Virginia Health Systems
  More Information

Publications:
Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00767403     History of Changes
Other Study ID Numbers: 13846, 5R01HD028160-16
Study First Received: October 3, 2008
Last Updated: April 2, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Encopresis
Fecal Incontinence
Signs and Symptoms, Digestive
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014