Trial Outcomes & Findings for Toilet Training Toddlers and Preschoolers (NCT NCT01747343)

NCT ID: NCT01747343

Last Updated: 2014-09-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: 2 months minus baseline
• Results posted on: 2014-09-01

Participant Flow

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

No children were excluded from the Study.

Participant milestones

Measure	Underwear/Differential Reinforcement All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
Baseline STARTED	4
Baseline COMPLETED	4
Baseline NOT COMPLETED	0
Underwear STARTED	4
Underwear COMPLETED	4
Underwear NOT COMPLETED	0
Underwear/Differential Reinforcement STARTED	4
Underwear/Differential Reinforcement COMPLETED	4
Underwear/Differential Reinforcement NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Toilet Training Toddlers and Preschoolers

Baseline characteristics by cohort

Measure	Underwear/Differential Reinforcement n=4 Participants All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	2.02 years STANDARD_DEVIATION 0.24 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months minus baseline

Outcome measures

Measure	Underwear/Differential Reinforcement n=4 Participants All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
Change in the Mean Number of Accidents Across Children	-1.3 Accidents Standard Deviation 1.3

SECONDARY outcome

Timeframe: 2 months minus baseline

Outcome measures

Measure	Underwear/Differential Reinforcement n=4 Participants All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
Change in the Mean Percentage of Appropriate Eliminations Across Children	33.4 Percentage of opportunities Standard Deviation 41.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 months minus baseline

Outcome measures

Measure	Underwear/Differential Reinforcement n=4 Participants All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children	2.7 Self-initiations Standard Deviation 4.1

Adverse Events

Underwear/Differential Reinforcement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian D. Greer, Ph.D.

University of Kansas

Phone: 386-852-7171

Email: brian.greer@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place