Group Toilet Training of Healthy Children, in Daycare Centers (CRCT)

January 16, 2020 updated by: Tinne Van Aggelpoel, University Hospital, Antwerp

Implementing a New Method of Group Toilet Training in Daycare Centers: a Cluster Randomised Controlled Trial

Evaluation of a new method of toilet training (TT), meaning TT in group in daycare centers, guided by a TT expert. Children are included based on signs of readiness for TT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A cluster randomized controlled trial (CRCT) was established in daycare centers. Clusters of participants (per daycare center) were randomly allocated to an Intervention group or a Control group.

Evolution of the TT process was monitored in the daycare center until the child was considered to be fully toilet trained (or 'clean') during the day (this means wearing undergarments, conscious of the need to void and initiating toilet behavior without reminder of the parents with a maximum of one leakage a day [9]).

Daycare workers evaluated the TT process of all participating children on a weekly basis. Parents were asked to fill in an online questionnaire when their child was completely toilet trained.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • knowledge of the Dutch language
  • aged between 18 and 30 months
  • not yet toilet trained during the day and night (diaper dependent)
  • Parents of the children had to be motivated to participate in the study and willing to invest time and effort in continuing the TT at home
  • Children met at least two of the following three signs of readiness: the child expresses a need to evacuate and shows awareness of the need to void or to have a bowel movement; the child insists on completing tasks without help and is proud of new skills; or the child can pull clothes up and down in a TT related context

Exclusion Criteria:

  • Children with urological, neurological, organical or behavior problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intensive toilet training group
Intervention group was subjected to an intensive TT group session lasting 2-hours during 2 consecutive days in daycare centers.
Other: Group toilet training in daycare
During the training, children wore underpants, were informed about potty training, were encouraged to drink often and were asked regularly if they felt the need to void. Tutors looked for elimination signals in the child and quickly responded by putting the child on the potty when he/she expressed the need to void or to defecate. Children were positively rewarded. Parents received a leaflet containing practical tips concerning TT and their child's successes of the past two days. They were asked to continue TT at home during the following weekend and longer if necessary. Daycare workers were asked to pay more attention on the TT during the following days and weeks to ensure the effect of the intervention.
ACTIVE_COMPARATOR: Standard care toilet training group
Children participating in control group did not receive the intensive training, but parents got a leaflet and were encouraged to start TT their child at home, in their own manner.
Other: Individual toilet training at home
Parents were encouraged to start TT their child, because they were considered as being ready to initiate TT. Children did not receive any intervention, but parents were asked to start TT in their own manner. Parents were allowed to search for information on methods of TT with their relatives, internet, books,...

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of toilet training
Time Frame: 6 weeks
Number of weeks needed for the child to become fully toilet trained
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of toilet training
Time Frame: 6 weeks
Number of children that acquire cleanliness at 6 weeks time
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Universiteit Antwerpen

Investigators

  • Principal Investigator: Van Aggelpoel, University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 23, 2017

Primary Completion (ACTUAL)

October 30, 2018

Study Completion (ACTUAL)

March 26, 2019

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (ACTUAL)

January 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B300201630079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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