Internet Intervention for Childhood Encopresis
Primary Purpose
Encopresis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet Intervention + Stepped Care
Internet Intervention
Patient Education Website
Sponsored by
About this trial
This is an interventional treatment trial for Encopresis
Eligibility 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).
Sites / Locations
- University of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Behavioral Health and Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
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)
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
Secondary encopretic symptoms (as defined by): 1. Appropriate bowel movement consistency 2. Reduced bowel-specific difficulties
Frequency and Severity of perianal pain
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
Website Utilization (as measured by): 1. Time spent on website 2. Number of log-ins 3. Number of completed website Modules and Follow-Ups
Full Information
NCT ID
NCT00767403
First Posted
October 3, 2008
Last Updated
April 2, 2012
Sponsor
University of Virginia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00767403
Brief Title
Internet Intervention for Childhood Encopresis
Official Title
An Internet Intervention for Childhood Constipation and Encopresis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encopresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Internet Intervention + Stepped Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education Website
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Frequency and Severity of perianal pain
Time Frame
Baseline, 6 weeks, 6 months, 1 year
Title
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
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee M Ritterband, PhD
Organizational Affiliation
University of Virginia Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System, Department of Psychiatry and Neurobehavioral Sciences, Behavioral Health and Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14516239
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. doi: 10.1037/0022-006X.71.5.910.
Results Reference
background
PubMed Identifier
12228330
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. doi: 10.1093/jpepsy/27.7.585.
Results Reference
background
PubMed Identifier
17032634
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. doi: 10.2196/jmir.8.3.e18. No abstract available.
Results Reference
background
PubMed Identifier
16263978
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. doi: 10.1542/peds.2005-0404.
Results Reference
background
PubMed Identifier
15805358
Citation
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.
Results Reference
background
PubMed Identifier
12904449
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. doi: 10.1093/jpepsy/jsg027.
Results Reference
background
PubMed Identifier
12755248
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. doi: 10.3122/jabfm.16.3.213.
Results Reference
background
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Internet Intervention for Childhood Encopresis
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