Internet Intervention for Childhood Encopresis

NCT00767403 | Completed

• 2 other identifiers: 138465R01HD028160-16
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Encopresis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (3)

1

EXPERIMENTAL

Behavioral: Internet Intervention + Stepped Care

2

ACTIVE COMPARATOR

Behavioral: Internet Intervention

3

ACTIVE COMPARATOR

Behavioral: Patient Education Website

Interventions

Internet Intervention + Stepped Care BEHAVIORAL

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.

1

Internet Intervention BEHAVIORAL

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.

2

Patient Education Website BEHAVIORAL

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.

3

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Behavioral Health and Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (7)

• 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. doi: 10.1037/0022-006X.71.5.910.

  PMID: 14516239 BACKGROUND

• 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. doi: 10.1093/jpepsy/27.7.585.

  PMID: 12228330 BACKGROUND

• Ritterband LM, Thorndike F. Internet interventions or patient education web sites? J Med Internet Res. 2006 Sep 29;8(3):e18; author reply e19. doi: 10.2196/jmir.8.3.e18. No abstract available.

  PMID: 17032634 BACKGROUND

• 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. doi: 10.1542/peds.2005-0404.

  PMID: 16263978 BACKGROUND

• 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. doi: 10.1542/peds.2004-0537.

  PMID: 15805358 BACKGROUND

• 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. doi: 10.1093/jpepsy/jsg027.

  PMID: 12904449 BACKGROUND

• 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. doi: 10.3122/jabfm.16.3.213.

  PMID: 12755248 BACKGROUND

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Lee M Ritterband, PhD

  University of Virginia Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 7, 2008
• Study Start: January 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

US (1)