Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067769
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2003-08-27
Brief Title:
Internet-based Treatment of Early Childhood Fecal Incontinence
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Treatment of Early Childhood ConstipationEncopresis
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HD028160-12 | NIH | None | httpsreporternihgovquickSearch5R01HD028160-12 |