NCT04221776

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

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 23, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

January 6, 2020

Last Update Submit

January 16, 2020

Conditions

Toilet TrainingChild, Preschool

Keywords

Method

Outcome Measures

Primary Outcomes (1)

  • Duration of toilet training

    Number of weeks needed for the child to become fully toilet trained

    6 weeks

Secondary Outcomes (1)

  • Effectiveness of toilet training

    6 weeks

Study Arms (2)

Intensive toilet training group

EXPERIMENTAL

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

Standard care toilet training group

ACTIVE COMPARATOR

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

Interventions

Group toilet training in daycareOTHER

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.

Intensive toilet training group
Individual toilet training at homeOTHER

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,...

Standard care toilet training group

Eligibility Criteria

Age18 Months - 30 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children with urological, neurological, organical or behavior problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Antwerp, Belgium

Location

Related Publications (1)

  • Van Aggelpoel T, De Wachter S, Neels H, Van Hal G, Roelant E, Vermandel A. Implementing a new method of group toilet training in daycare centres: a cluster randomised controlled trial. Eur J Pediatr. 2021 May;180(5):1393-1401. doi: 10.1007/s00431-020-03879-y. Epub 2020 Nov 23.

    PMID: 33230718DERIVED

MeSH Terms

Interventions

Child Day Care Centers

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private FacilitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Van Aggelpoel

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pelvic floor physiotherapist

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 9, 2020

Study Start

November 23, 2017

Primary Completion

October 30, 2018

Study Completion

March 26, 2019

Last Updated

January 21, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)