Toilet Training Toddlers and Preschoolers

Incontinence Clinical Trial

Official title:

Changing the Number of Accidents, Percentage of Appropriate Eliminations, and Number of Self-Initiations Across Toddlers and Preschoolers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747343
• Other study ID #: HSCL-17816
• 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

• Enuresis
• Incontinence

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