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

Child, Preschool Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04221776
• Other study ID #: B300201630079
• Status: Completed
• Phase: N/A
• Start date: November 23, 2017
• Est. completion date: March 26, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 26, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 30 Months

Eligibility

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

Related Conditions & MeSH terms

• Child, Preschool
• Toilet Training

Intervention

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.
• 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,...

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of toilet training	Number of weeks needed for the child to become fully toilet trained	6 weeks
Secondary	Effectiveness of toilet training	Number of children that acquire cleanliness at 6 weeks time	6 weeks