NCT01747343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

8 months

First QC Date

December 7, 2012

Results QC Date

July 8, 2014

Last Update Submit

August 21, 2014

Conditions

Keywords

IncontinenceEnuresis

Outcome Measures

Primary Outcomes (1)

  • Change in the Mean Number of Accidents Across Children

    2 months minus baseline

Secondary Outcomes (1)

  • Change in the Mean Percentage of Appropriate Eliminations Across Children

    2 months minus baseline

Other Outcomes (1)

  • Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children

    2 months minus baseline

Study Arms (1)

Underwear/Differential Reinforcement

EXPERIMENTAL

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

Behavioral: Underwear/Differential Reinforcement

Interventions

Participants are going to be placed in underwear. Differential reinforcement will then be implemented.

Underwear/Differential Reinforcement

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individual not yet toilet trained

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Enuresis

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Results Point of Contact

Title
Brian D. Greer, Ph.D.
Organization
University of Kansas

Study Officials

  • Brian D Greer, Ph.D.

    Doctoral Student (Graduated)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 11, 2012

Study Start

November 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 1, 2014

Results First Posted

September 1, 2014

Record last verified: 2014-08

Locations