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Toilet Training Toddlers and Preschoolers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01747343
Enrollment
4
Registered
2012-12-11
Start date
2012-11-30
Completion date
2013-07-31
Last updated
2014-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enuresis, Incontinence

Keywords

Incontinence, Enuresis

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.

Interventions

BEHAVIORALUnderwear/Differential Reinforcement

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

Sponsors

University of Kansas
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Individual not yet toilet trained

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Change in the Mean Number of Accidents Across Children2 months minus baseline

Secondary

MeasureTime frame
Change in the Mean Percentage of Appropriate Eliminations Across Children2 months minus baseline

Other

MeasureTime frame
Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children2 months minus baseline

Countries

United States

Participant flow

Recruitment details

Four children were recruited from the Edna A. Hill Child Development Center at the University of Kansas from November 2012 until July 2013.

Pre-assignment details

No children were excluded from the Study.

Participants by arm

ArmCount
Underwear/Differential Reinforcement
All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
4
Total4

Baseline characteristics

CharacteristicUnderwear/Differential Reinforcement
Age, Categorical
<=18 years
4 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous2.02 years
STANDARD_DEVIATION 0.24
Region of Enrollment
United States
4 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 4
serious
Total, serious adverse events
0 / 4

Outcome results

Primary

Change in the Mean Number of Accidents Across Children

Time frame: 2 months minus baseline

ArmMeasureValue (MEAN)Dispersion
Underwear/Differential ReinforcementChange in the Mean Number of Accidents Across Children-1.3 AccidentsStandard Deviation 1.3
Secondary

Change in the Mean Percentage of Appropriate Eliminations Across Children

Time frame: 2 months minus baseline

ArmMeasureValue (MEAN)Dispersion
Underwear/Differential ReinforcementChange in the Mean Percentage of Appropriate Eliminations Across Children33.4 Percentage of opportunitiesStandard Deviation 41.3
Other Pre-specified

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

Time frame: 2 months minus baseline

ArmMeasureValue (MEAN)Dispersion
Underwear/Differential ReinforcementChange in the Mean Number of Self-initiations to Sit on the Toilet Across Children2.7 Self-initiationsStandard Deviation 4.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026