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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01747343
Other study ID # HSCL-17816
Secondary ID
Status Completed
Phase N/A
First received December 7, 2012
Last updated August 21, 2014
Start date November 2012
Est. completion date July 2013

Study information

Verified date August 2014
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Months and older
Eligibility Inclusion Criteria:

- Individual not yet toilet trained

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Underwear/Differential Reinforcement
Participants are going to be placed in underwear. Differential reinforcement will then be implemented.

Locations

Country Name City State
United States Edna A. Hill Child Development Center at the University of Kansas Lawrence Kansas

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children 2 months minus baseline No
Primary Change in the Mean Number of Accidents Across Children 2 months minus baseline No
Secondary Change in the Mean Percentage of Appropriate Eliminations Across Children 2 months minus baseline No
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