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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

October 3, 2008
April 2, 2012
January 2010
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00767403 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Internet Intervention for Childhood Encopresis
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Encopresis
  • 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.
  • 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.
  • 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.
  • Experimental: 1
    Intervention: Behavioral: Internet Intervention + Stepped Care
  • Active Comparator: 2
    Intervention: Behavioral: Internet Intervention
  • Active Comparator: 3
    Intervention: Behavioral: Patient Education Website

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
March 2012
March 2012   (final data collection date for primary outcome measure)

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).
Both
5 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00767403
13846, 5R01HD028160-16
Not Provided
University of Virginia
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Lee M Ritterband, PhD University of Virginia Health Systems
University of Virginia
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP