Clinical trial NCT00067769: Internet-based Treatment of Early Childhood Fecal Incontinence
Official title: Treatment of Early Childhood Constipation/Encopresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Encopresis
Keywords: Encopresis
Internet
Web
Treatment
Intervention
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2003-08-28
Enrollment: 91
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Fecal accident outcomes with online diary data
timeFrame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
measure: Success and cure rates
timeFrame: Post (4-6 weeks) and one year Post after the intervention period (4-6 weeks)
Secondary outcomes:
measure: Fecal accident outcomes with retrospective data
timeFrame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
measure: Parent knowledge of encopresis
timeFrame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
measure: Virginia Encopresis Constipation Apperception Test (VECAT)
timeFrame: Pre, Post (4-6 weeks), and one year Post after the intervention period (4-6 weeks)
measure: Encopresis Cost Analysis
timeFrame: Pre and Post (4-6 weeks)
Other outcomes:
measure: Usage patterns of the Internet intervention
timeFrame: Post (4-6 weeks)
measure: Internet Intervention Utility Measure of Satisfaction
timeFrame: Post (4-6 weeks)
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Daniel J Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1037/0022-006X.71.5.910.
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. doi: 10.1093/jpepsy/27.7.585.
citation: 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.
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. doi: 10.1007/BF02895121.
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. doi: 10.1097/00004703-199906000-00002.
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. doi: 10.1007/BF02884451.
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. doi: 10.1093/jpepsy/21.5.659.
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. doi: 10.1177/000992289603500814. No abstract available.