- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01747343
Toilet Training Toddlers and Preschoolers
Changing the Number of Accidents, Percentage of Appropriate Eliminations, and Number of Self-Initiations Across Toddlers and Preschoolers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
First, the effects of the baseline toileting program are assessed. Baseline consists of prompting the child to use the bathroom approximately every 90 min (or more frequently if they independently request to do so). If the investigators observe low levels of continence, appropriate eliminations, and/or independent/self requests, components of the program are systematically altered to increase success. The ultimate goal is for the child to remain continent throughout the day, independently request (or initiate) toilet use, and appropriately eliminate in the toilet once in the bathroom. The following procedural modifications are made if high levels of success are not observed in baseline:
The first modification is to change the child's undergarment type. Specifically, underwear will be used, and it's effects will be evaluated to determine what effect (if any) underwear has on toileting performance.
The second modification is to conduct an individualized preference assessment to identify types of food and leisure items a given child prefers. This is done by having the child select items from an array (items selected based on direct observations of child and parent/teacher report) and allowing him/her access to the chosen item for a brief period of time. This will generate a list of preferred items/activities ranked in order of relative preference. Subsequently, the highest ranked items from the preference assessment will be arranged as reinforcers for continence, appropriate eliminations, and self-initiations. A third modification is to combine the above modifications to determine whether a combination of toilet training procedures enhances toileting performance (as compare to the implementation of individual toilet training procedures). This modification will be conducted while children wear underwear.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Lawrence, Kansas, United States, 66045
- Edna A. Hill Child Development Center at the University of Kansas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individual not yet toilet trained
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Underwear/Differential Reinforcement
All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
|
Participants are going to be placed in underwear.
Differential reinforcement will then be implemented.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in the Mean Number of Accidents Across Children
Time Frame: 2 months minus baseline
|
2 months minus baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in the Mean Percentage of Appropriate Eliminations Across Children
Time Frame: 2 months minus baseline
|
2 months minus baseline
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children
Time Frame: 2 months minus baseline
|
2 months minus baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian D Greer, Ph.D., Doctoral Student (Graduated)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSCL-17816
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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