Internet-based Treatment of Early Childhood Fecal Incontinence

Encopresis Clinical Trial

Official title:

Treatment of Early Childhood Constipation/Encopresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067769
• Other study ID #: 11116
• Secondary ID: 5R01HD028160-12
• Status: Completed
• Phase: N/A
• First received: August 27, 2003
• Last updated: December 4, 2015
• Start date: October 2003
• Est. completion date: July 2007

Study information

• Verified date: June 2014
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Encopresis

Intervention

Behavioral:
• Internet-based intervention UCanPoopToo
Internet-based intervention to administer Enhanced Toilet Training (ETT).
• treatment as usual
Routine clinical care.

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usage patterns of the Internet intervention	Usage (number of Cores completed; number of Follow-ups completed and Modules assigned)	Post (4-6 weeks)	No
Other	Internet Intervention Utility Measure of Satisfaction	Parent and child rated their satisfaction with the Internet intervention using the Internet Intervention Utility Questionnaire.	Post (4-6 weeks)	No
Primary	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)	No
Primary	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)	No
Secondary	Fecal accident outcomes with retrospective data	Number of accidents per 2 week period	Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)	No
Secondary	Parent knowledge of encopresis	Parent knowledge of encopresis was assessed on a revised version of the Encopresis Knowledge Scale (EKS).	Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)	No
Secondary	Virginia Encopresis Constipation Apperception Test (VECAT)	Parent assessment of child's bowel specific problems related to encopresis and constipation.	Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)	No
Secondary	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.	Pre and Post (4-6 weeks)	No

External Links

•   A description of the study for interested clinicians