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EncopresisNCT00067769

Internet-based Treatment of Early Childhood Fecal Incontinence

A study testing Internet-based intervention UCanPoopToo and treatment as usual in people with Encopresis, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Encopresis
What is being tested?
Internet-based intervention UCanPoopToo and treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteUnited States
Study dates
Oct 2003to Jul 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • Diagnosis of either mental retardation (IQ < 85) or
  • A primary illness responsible for fecal soiling (e.g., spina bifida)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia Health System

    Charlottesville, Virginia, 22902

Other trials in United States

About this study

Official title: Treatment of Early Childhood Constipation/Encopresis

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.

Read the 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.

Conditions
Encopresis
Being tested
Internet-based intervention UCanPoopToo, treatment as usual
Keywords
Encopresis, Internet, Web, Treatment, Intervention
Medical subject headings
Encopresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based intervention UCanPoopTooBehavioural

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

  • treatment as usualBehavioural

    Routine clinical care.

Study groups in NCT00067769
Study groupRoleWhat they receive
TAUActive comparatorPatients received treatment as usual (TAU) as defined as continued clinical care.
Receives: Behavioral: treatment as usual
TAU+UCanPoopTooExperimentalPatients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)
Receives: Behavioral: Internet-based intervention UCanPoopToo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fecal accident outcomes with online diary data

    Number of accidents per 2 week period

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

  2. 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.

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

Secondary outcomes (4)

  1. Fecal accident outcomes with retrospective data

    Number of accidents per 2 week period

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

  2. Parent knowledge of encopresis

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

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

  3. Virginia Encopresis Constipation Apperception Test (VECAT)

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

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

  4. 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.

    Measured: Pre and Post (4-6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067769
Sponsor's protocol ID
11116
Other IDs
5R01HD028160-12
Status last verified
Jun 2014
First submitted
27 Aug 2003
Last updated
7 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 14516239

  • 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.

    PubMed 12228330

  • 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.

    PubMed 11930093

  • 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.

    PubMed 11211851

  • 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.

    PubMed 10393070

  • 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.

    PubMed 9989311

  • 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.

    PubMed 8936895

  • 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.

    PubMed 8862907

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based intervention UCanPoopToo and treatment as usual in people with Encopresis, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00067769, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.

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