Toilet TrainingNCT04221776
Group Toilet Training of Healthy Children, in Daycare Centers (CRCT)
A study testing Group toilet training in daycare and Individual toilet training at home in people with Toilet Training and Child, Preschool, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Toilet Training, Child, Preschool
- What is being tested?
- Group toilet training in daycare and Individual toilet training at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Nov 2017to 26 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children with urological, neurological, organical or behavior problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Toilet Training, Child, Preschool
- Being tested
- Group toilet training in daycare, Individual toilet training at home
- Keywords
- Method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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,...
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Individual toilet training at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of toilet training
Number of weeks needed for the child to become fully toilet trained
Measured: 6 weeks
Secondary outcomes (1)
Effectiveness of toilet training
Number of children that acquire cleanliness at 6 weeks time
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start23 Nov 2017
- Primary completion30 Oct 2018
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Toilet TrainingStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Tinne Van Aggelpoel, University Hospital, Antwerp
- Investigators
- Van Aggelpoel, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221776
- Sponsor's protocol ID
- B300201630079
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33230718
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a New Method of Group Toilet Training in Daycare Centers: a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04221776
- Acronym / sponsor ID
- B300201630079
- Conditions
- Toilet Training, Child, Preschool
- Keywords
- Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive toilet training group | Experimental | Other: Group toilet training in daycareIntervention group was subjected to an intensive TT group session lasting 2-hours during 2 consecutive days in daycare centers. |
| Standard care toilet training group | Active comparator | Other: Individual toilet training at homeChildren 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. |
Who may qualify
- Ages
- 18 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Children with urological, neurological, organical or behavior problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group toilet training in daycareDuring 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. | Other | Intensive toilet training group |
| Individual toilet training at homeParents 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,... | Other | Standard care toilet training group |
Primary outcome
Duration of toilet training
Time frame: 6 weeks
Number of weeks needed for the child to become fully toilet trained
1 secondary outcome
Effectiveness of toilet training
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Derived from this study: PubMed 33230718Van 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.
- Individual participant dataSharing planned: No
Related trials for Toilet Training
Active, not recruiting
Bowel And Bladder Function in Infant Toilet Training
Infantile Colic, Constipation - Functional
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Van Aggelpoel principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group toilet training in daycare and Individual toilet training at home in people with Toilet Training and Child, Preschool, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of toilet training (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.