Internet-based Treatment of Early Childhood Fecal Incontinence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT00067769
First received: August 27, 2003
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Encopresis
Behavioral: Internet-based intervention UCanPoopToo
Behavioral: treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Early Childhood Constipation/Encopresis

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Fecal accident outcomes with online diary data [ Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks) ] [ Designated as safety issue: No ]
    Number of accidents per 2 week period

  • Success and cure rates [ Time Frame: Post (4-6 weeks) and one year Post after the intervention period (4-6 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks) ] [ Designated as safety issue: No ]
    Number of accidents per 2 week period

  • Parent knowledge of encopresis [ Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks) ] [ Designated as safety issue: No ]
    Parent knowledge of encopresis was assessed on a revised version of the Encopresis Knowledge Scale (EKS).

  • Virginia Encopresis Constipation Apperception Test (VECAT) [ Time Frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks) ] [ Designated as safety issue: No ]
    Parent assessment of child's bowel specific problems related to encopresis and constipation.

  • Encopresis Cost Analysis [ Time Frame: Pre and Post (4-6 weeks) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Usage patterns of the Internet intervention [ Time Frame: Post (4-6 weeks) ] [ Designated as safety issue: No ]
    Usage (number of Cores completed; number of Follow-ups completed and Modules assigned)

  • Internet Intervention Utility Measure of Satisfaction [ Time Frame: Post (4-6 weeks) ] [ Designated as safety issue: No ]
    Parent and child rated their satisfaction with the Internet intervention using the Internet Intervention Utility Questionnaire.


Enrollment: 91
Study Start Date: October 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAU
Patients received treatment as usual (TAU) as defined as continued clinical care.
Behavioral: treatment as usual
Routine clinical care.
Experimental: TAU+UCanPoopToo
Patients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)
Behavioral: Internet-based intervention UCanPoopToo
Internet-based intervention to administer Enhanced Toilet Training (ETT).

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067769

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22902
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Daniel J Cox, PhD University of Virginia
  More Information

Additional Information:
Publications:

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00067769     History of Changes
Other Study ID Numbers: 11116, 5R01HD028160-12
Study First Received: August 27, 2003
Last Updated: June 16, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Virginia:
Encopresis
Internet
Web
Treatment
Intervention

Additional relevant MeSH terms:
Encopresis
Fecal Incontinence
Signs and Symptoms, Digestive
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014