Internet-based Treatment of Early Childhood Fecal Incontinence
Primary Purpose
Encopresis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based intervention UCanPoopToo
treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Encopresis focused on measuring Encopresis, Internet, Web, Treatment, Intervention
Eligibility Criteria
Inclusion Criteria Child seen by pediatrician, family physician, or psychologist for the treatment of encopresis Access to the Internet, either through a family computer or a community computer Exclusion Criteria Diagnosis of either mental retardation (IQ < 85) or A primary illness responsible for fecal soiling (e.g., spina bifida)
Sites / Locations
- University of Virginia Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TAU
TAU+UCanPoopToo
Arm Description
Patients received treatment as usual (TAU) as defined as continued clinical care.
Patients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)
Outcomes
Primary Outcome Measures
Fecal accident outcomes with online diary data
Number of accidents per 2 week period
Success and cure rates
Success rate as defined by having zero or one fecal accident over a two week period. Cure rate as defined by having zero accidents over the previous two weeks.
Secondary Outcome Measures
Fecal accident outcomes with retrospective data
Number of accidents per 2 week period
Parent knowledge of encopresis
Parent knowledge of encopresis was assessed on a revised version of the Encopresis Knowledge Scale (EKS).
Virginia Encopresis Constipation Apperception Test (VECAT)
Parent assessment of child's bowel specific problems related to encopresis and constipation.
Encopresis Cost Analysis
Participants quantified items and events that occurred which contribute to the cost of encopresis such as number of diapers used, number of school days missed, number of parent trips to school, and clean-out procedures then cost estimates were applied to each.
Full Information
NCT ID
NCT00067769
First Posted
August 27, 2003
Last Updated
December 4, 2015
Sponsor
University of Virginia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00067769
Brief Title
Internet-based Treatment of Early Childhood Fecal Incontinence
Official Title
Treatment of Early Childhood Constipation/Encopresis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Encopresis, also known as fecal incontinence, is the voluntary or involuntary passage of stools causing soiling of clothes by a child over 4 years of age. The purpose of this study is to evaluate an Internet intervention for the treatment of encopresis.
Detailed Description
An estimated 2.3% of children suffer from encopresis. Enhanced Toilet Training (ETT) is one of the most effective ways of treating this disorder. When delivered by skilled and knowledgeable clinicians, ETT is twice as effective as intensive medical management alone. Although ETT is effective in treating encopretic children, there are six major barriers to its implementation: 1) availability of a knowledgeable and skilled clinician; 2) parental acceptance of referral to a mental health professional; 3) expense of service; 4) burden of time and distance to access such specialty services; 5) child resistance to disclosure of embarrassing material; and 6) willingness of the child and parent to follow treatment recommendations. This project will circumvent these barriers by developing an interactive Internet-based ETT program. The study will then assess the feasibility of the program by determining the acceptance, function, and effectiveness of the intervention.
This project will have four phases. Phase 1 will identify optimal Internet and treatment elements as well as issues in need of experimental investigation. Phase 2 will investigate how to enhance Internet interventions. Phase 3 will evaluate the relative benefit of adding the Internet treatment to clinical services provided by clinicians in the fields of medicine and mental health. Phase 4 will investigate the relative long-term benefits of adding such an Internet-based intervention to professional care to determine its impact on symptom improvement, relapse prevention, quality of life, and its cost-effectiveness. Phase 4 will also assess to what extent the program is disseminated worldwide when made available on the Internet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encopresis
Keywords
Encopresis, Internet, Web, Treatment, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Patients received treatment as usual (TAU) as defined as continued clinical care.
Arm Title
TAU+UCanPoopToo
Arm Type
Experimental
Arm Description
Patients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)
Intervention Type
Behavioral
Intervention Name(s)
Internet-based intervention UCanPoopToo
Intervention Description
Internet-based intervention to administer Enhanced Toilet Training (ETT).
Intervention Type
Behavioral
Intervention Name(s)
treatment as usual
Intervention Description
Routine clinical care.
Primary Outcome Measure Information:
Title
Fecal accident outcomes with online diary data
Description
Number of accidents per 2 week period
Time Frame
Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Title
Success and cure rates
Description
Success rate as defined by having zero or one fecal accident over a two week period. Cure rate as defined by having zero accidents over the previous two weeks.
Time Frame
Post (4-6 weeks) and one year Post after the intervention period (4-6 weeks)
Secondary Outcome Measure Information:
Title
Fecal accident outcomes with retrospective data
Description
Number of accidents per 2 week period
Time Frame
Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Title
Parent knowledge of encopresis
Description
Parent knowledge of encopresis was assessed on a revised version of the Encopresis Knowledge Scale (EKS).
Time Frame
Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Title
Virginia Encopresis Constipation Apperception Test (VECAT)
Description
Parent assessment of child's bowel specific problems related to encopresis and constipation.
Time Frame
Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
Title
Encopresis Cost Analysis
Description
Participants quantified items and events that occurred which contribute to the cost of encopresis such as number of diapers used, number of school days missed, number of parent trips to school, and clean-out procedures then cost estimates were applied to each.
Time Frame
Pre and Post (4-6 weeks)
Other Pre-specified Outcome Measures:
Title
Usage patterns of the Internet intervention
Description
Usage (number of Cores completed; number of Follow-ups completed and Modules assigned)
Time Frame
Post (4-6 weeks)
Title
Internet Intervention Utility Measure of Satisfaction
Description
Parent and child rated their satisfaction with the Internet intervention using the Internet Intervention Utility Questionnaire.
Time Frame
Post (4-6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Child seen by pediatrician, family physician, or psychologist for the treatment of encopresis
Access to the Internet, either through a family computer or a community computer
Exclusion Criteria
Diagnosis of either mental retardation (IQ < 85) or
A primary illness responsible for fecal soiling (e.g., spina bifida)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Cox, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
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
11930093
Citation
Borowitz SM, Cox DJ, Sutphen JL, Kovatchev B. Treatment of childhood encopresis: a randomized trial comparing three treatment protocols. J Pediatr Gastroenterol Nutr. 2002 Apr;34(4):378-84. doi: 10.1097/00005176-200204000-00012.
Results Reference
background
PubMed Identifier
11211851
Citation
Brooks RC, Copen RM, Cox DJ, Morris J, Borowitz S, Sutphen J. Review of the treatment literature for encopresis, functional constipation, and stool-toileting refusal. Ann Behav Med. 2000 Summer;22(3):260-7. doi: 10.1007/BF02895121.
Results Reference
background
PubMed Identifier
10393070
Citation
Borowitz SM, Cox DJ, Sutphen JL. Differences in toileting habits between children with chronic encopresis, asymptomatic siblings, and asymptomatic nonsiblings. J Dev Behav Pediatr. 1999 Jun;20(3):145-9. doi: 10.1097/00004703-199906000-00002.
Results Reference
background
PubMed Identifier
9989311
Citation
Cox DJ, Sutphen J, Borowitz S, Kovatchev B, Ling W. Contribution of behavior therapy and biofeedback to laxative therapy in the treatment of pediatric encopresis. Ann Behav Med. 1998 Spring;20(2):70-6. doi: 10.1007/BF02884451.
Results Reference
background
PubMed Identifier
8936895
Citation
Cox DJ, Sutphen J, Ling W, Quillian W, Borowitz S. Additive benefits of laxative, toilet training, and biofeedback therapies in the treatment of pediatric encopresis. J Pediatr Psychol. 1996 Oct;21(5):659-70. doi: 10.1093/jpepsy/21.5.659.
Results Reference
background
PubMed Identifier
8862907
Citation
Ling W, Cox DJ, Sutphen J, Borowitz S. Psychological factors in encopresis: comparison of patients to nonsymptomatic siblings. Clin Pediatr (Phila). 1996 Aug;35(8):427. doi: 10.1177/000992289603500814. No abstract available.
Results Reference
background
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Internet-based Treatment of Early Childhood Fecal Incontinence
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