Increasing Independent Toileting Skills in Toddlers and Preschoolers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01747343
First received: December 7, 2012
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Incontinence
Enuresis
Other: Underwear
Other: Underwear plus differential reinforcement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Increasing Independent Toileting Skills in Toddlers and Preschoolers

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Change in the frequency of accidents [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the frequency of appropriate eliminations [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in the frequency of self-initiations to sit on the toilet [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 4
Study Start Date: November 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Underwear/Differential Reinforcement
All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
Other: Underwear Other: Underwear plus differential reinforcement

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 evaluate 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.

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individual not yet toilet trained

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747343

Contacts
Contact: Brian D. Greer, M.A. 785-864-3424 bgreer@ku.edu
Contact: Pamela L. Neidert, Ph.D. 785-864-0771 pneidert@ku.edu

Locations
United States, Kansas
Edna A. Hill Child Development Center at the University of Kansas Recruiting
Lawrence, Kansas, United States, 66045
Contact: Brian D Greer, M.A.    785-864-3424    bgreer@ku.edu   
Contact: Pamela L. Neidert, Ph.D.    785-864-0771    pneidert@ku.edu   
Principal Investigator: Brian D. Greer, M.A.         
Principal Investigator: Pamela L. Neidert, Ph.D.         
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Brian D Greer, M.A. Doctoral Student
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01747343     History of Changes
Other Study ID Numbers: HSCL-17816
Study First Received: December 7, 2012
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Incontinence
Enuresis

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014