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