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Toilet Training Toddlers and Preschoolers

Primary Purpose

Incontinence, Enuresis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Underwear/Differential Reinforcement
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incontinence focused on measuring Incontinence, Enuresis

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individual not yet toilet trained

Exclusion Criteria:

  • None

Sites / Locations

  • Edna A. Hill Child Development Center at the University of Kansas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Underwear/Differential Reinforcement

Arm Description

All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.

Outcomes

Primary Outcome Measures

Change in the Mean Number of Accidents Across Children

Secondary Outcome Measures

Change in the Mean Percentage of Appropriate Eliminations Across Children

Full Information

First Posted
December 7, 2012
Last Updated
August 21, 2014
Sponsor
University of Kansas
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1. Study Identification

Unique Protocol Identification Number
NCT01747343
Brief Title
Toilet Training Toddlers and Preschoolers
Official Title
Changing the Number of Accidents, Percentage of Appropriate Eliminations, and Number of Self-Initiations Across Toddlers and Preschoolers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are interested in determining those procedures that prove to be most efficient and effective in facilitating continence (i.e., "dry pants" or the absence of soiled undergarments), appropriate eliminations (i.e., voids/stools in toilet), and independent requests/initiations to use the toilet. To assess the effectiveness of toilet training methods (procedures), data on toileting skills (in addition to each skill in a given child's curriculum) are collected across the school day (7:30 am-5:45 pm) by the classroom teachers. The primary dependent variables (toileting skills) are continence (i.e., absence of soiled undergarments), appropriate eliminations (i.e., the number of voids/stools made in the toilet), and independent/self requests (i.e., communication by the child with an adult to use the toilet). The toileting procedures are implemented by classroom teachers (undergraduate practicum students) and implementation is monitored by classroom supervisors (graduate teaching assistants). Procedural effectiveness is evaluated on a daily basis by the graduate teaching assistants and on an at-least-weekly basis by faculty supervisors.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Enuresis
Keywords
Incontinence, Enuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Underwear/Differential Reinforcement
Arm Type
Experimental
Arm Description
All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
Intervention Type
Behavioral
Intervention Name(s)
Underwear/Differential Reinforcement
Intervention Description
Participants are going to be placed in underwear. Differential reinforcement will then be implemented.
Primary Outcome Measure Information:
Title
Change in the Mean Number of Accidents Across Children
Time Frame
2 months minus baseline
Secondary Outcome Measure Information:
Title
Change in the Mean Percentage of Appropriate Eliminations Across Children
Time Frame
2 months minus baseline
Other Pre-specified Outcome Measures:
Title
Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children
Time Frame
2 months minus baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individual not yet toilet trained Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian D Greer, Ph.D.
Organizational Affiliation
Doctoral Student (Graduated)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edna A. Hill Child Development Center at the University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States

12. IPD Sharing Statement

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Toilet Training Toddlers and Preschoolers

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