Internet-based Treatment of Early Childhood Fecal Incontinence

NCT00067769 | Completed

• 2 other identifiers: 111165R01HD028160-12
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Encopresis

Keywords

Encopresis; Internet; Web; Treatment; Intervention

Outcome Measures

Primary Outcomes (2)

• Fecal accident outcomes with online diary data

  Number of accidents per 2 week period

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

• 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.

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

Secondary Outcomes (4)

• Fecal accident outcomes with retrospective data

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

• Parent knowledge of encopresis

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

• Virginia Encopresis Constipation Apperception Test (VECAT)

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

• Encopresis Cost Analysis

  Pre and Post (4-6 weeks)

Other Outcomes (2)

• Usage patterns of the Internet intervention

  Post (4-6 weeks)

• Internet Intervention Utility Measure of Satisfaction

  Post (4-6 weeks)

Study Arms (2)

TAU

ACTIVE COMPARATOR

Patients received treatment as usual (TAU) as defined as continued clinical care.

Behavioral: treatment as usual

TAU+UCanPoopToo

EXPERIMENTAL

Patients received treatment as usual (TAU) plus the Internet intervention (UCanPoopToo.)

Behavioral: Internet-based intervention UCanPoopToo

Interventions

Internet-based intervention UCanPoopToo BEHAVIORAL

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

TAU+UCanPoopToo

treatment as usual BEHAVIORAL

Routine clinical care.

TAU

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22902, United States

Location

Related Publications (8)

• 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.

  PMID: 14516239 BACKGROUND

• 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.

  PMID: 12228330 BACKGROUND

• 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.

  PMID: 11930093 BACKGROUND

• 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.

  PMID: 11211851 BACKGROUND

• 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.

  PMID: 10393070 BACKGROUND

• 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.

  PMID: 9989311 BACKGROUND

• 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.

  PMID: 8936895 BACKGROUND

• 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.

  PMID: 8862907 BACKGROUND

MeSH Terms

Conditions

Encopresis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel J Cox, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and NB Sciences

Study Record Dates

• First Submitted: August 27, 2003
• First Posted: August 28, 2003
• Study Start: October 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 7, 2015

Record last verified: 2014-06

Locations

US (1)