Internet Intervention for Childhood Encopresis

Encopresis Clinical Trial

Official title:

An Internet Intervention for Childhood Constipation and Encopresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767403
• Other study ID #: 13846
• Secondary ID: 5R01HD028160-16
• Status: Completed
• Phase: N/A
• First received: October 3, 2008
• Last updated: April 2, 2012
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Encopresis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Behavioral Health and Technology	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Borowitz SM, Cox DJ, Kovatchev B, Ritterband LM, Sheen J, Sutphen J. Treatment of childhood constipation by primary care physicians: efficacy and predictors of outcome. Pediatrics. 2005 Apr;115(4):873-7. — View Citation

Borowitz SM, Cox DJ, Tam A, Ritterband LM, Sutphen JL, Penberthy JK. Precipitants of constipation during early childhood. J Am Board Fam Pract. 2003 May-Jun;16(3):213-8. — View Citation

Cox DJ, Morris JB Jr, Borowitz SM, Sutphen JL. Psychological differences between children with and without chronic encopresis. J Pediatr Psychol. 2002 Oct-Nov;27(7):585-91. — View Citation

Cox DJ, Ritterband LM, Quillian W, Kovatchev B, Morris J, Sutphen J, Borowitz S. Assessment of behavioral mechanisms maintaining encopresis: Virginia Encopresis-Constipation Apperception Test. J Pediatr Psychol. 2003 Sep;28(6):375-82. — View Citation

Ritterband LM, Borowitz S, Cox DJ, Kovatchev B, Walker LS, Lucas V, Sutphen J. Using the internet to provide information prescriptions. Pediatrics. 2005 Nov;116(5):e643-7. — View Citation

Ritterband LM, Cox DJ, Walker LS, Kovatchev B, McKnight L, Patel K, Borowitz S, Sutphen J. An Internet intervention as adjunctive therapy for pediatric encopresis. J Consult Clin Psychol. 2003 Oct;71(5):910-7. — View Citation

Ritterband LM, Thorndike F. Internet interventions or patient education web sites? J Med Internet Res. 2006 Sep 29;8(3):e18; author reply e19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Secondary encopretic symptoms (as defined by): 1. Appropriate bowel movement consistency 2. Reduced bowel-specific difficulties		Baseline, 6 weeks, 6 months, 1 year	No
Secondary	Frequency and Severity of perianal pain		Baseline, 6 weeks, 6 months, 1 year	No
Secondary	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	No
Secondary	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)	No