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Completed

NCT Number: NCT00067769

Internet-based Treatment of Early Childhood Fecal Incontinence

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.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Internet-based intervention UCanPoopToo

Behavioral

Internet-based intervention to administer Enhanced Toilet Training (ETT).

Treatment as Usual

Behavioral

Routine clinical care.

Primary outcomes

  1. 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)

    Number of accidents per 2 week period

  2. Success and cure rates

    Time frame: Post (4-6 weeks) and one year Post after the intervention period (4-6 weeks)

    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 outcomes

  1. Fecal accident outcomes with retrospective data

    Time frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)

    Number of accidents per 2 week period

  2. Parent knowledge of encopresis

    Time frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)

    Parent knowledge of encopresis was assessed on a revised version of the Encopresis Knowledge Scale (EKS).

  3. Virginia Encopresis Constipation Apperception Test (VECAT)

    Time frame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)

    Parent assessment of child's bowel specific problems related to encopresis and constipation.

  4. Encopresis Cost Analysis

    Time frame: Pre and Post (4-6 weeks)

    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 outcomes

  1. Usage patterns of the Internet intervention

    Time frame: Post (4-6 weeks)

    Usage (number of Cores completed; number of Follow-ups completed and Modules assigned)

  2. Internet Intervention Utility Measure of Satisfaction

    Time frame: Post (4-6 weeks)

    Parent and child rated their satisfaction with the Internet intervention using the Internet Intervention Utility Questionnaire.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Treatment of Early Childhood Constipation/Encopresis

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Aug 28, 2003
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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