Autistic DisorderNCT02369445
Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
A study testing Moisture Pager Intervention for Toilet Training in people with Autistic Disorder and Enuresis, run by University of Rochester at 3 sites in United States.
Trial summary
The purpose of this pilot study is to compare an innovative toilet training strategy with a standard behavioral intervention in children with autism spectrum disorder (ASD), as implemented by teachers in the school setting. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder, Enuresis
- What is being tested?
- Moisture Pager Intervention for Toilet Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2014to 1 Jun 2018
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion criteria for participating children are as follows:
- ASD diagnosis confirmed through administration of the ADOS-2,
- status consistent with DSM-5 diagnosis of primary daytime enuresis, with the exception of DSM-5 criterion that child is at least 5 years old, confirmed by the K-SADS,
- a positive determination of readiness for toilet training, as determined through a Toileting Readiness Checklist, developed through a review of relevant literature on toilet training children with ASD (with 4 out of 7 signs in the checklist, with 3 of these criteria required),
- not on medication or stable for the past three months with no anticipated changes during the three-month intervention period, and
- consent from participating teachers and parents.
Who cannot join
- medical conditions that would interfere with toilet training procedures and are not well controlled (e.g., diabetes, urinary tract infection, or seizures),
- physical disorder that may contribute to incontinence (e.g., physical disabilities, chronic constipation) and
- medication for enuresis.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nationwide Children's Hospital
Columbus, Ohio, 43210
Whitney Loring
Nashville, Tennessee, 37235
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The purpose of this pilot study is to compare an innovative toilet training strategy with a standard behavioral intervention in children with autism spectrum disorder (ASD), as implemented by teachers in the school setting. Thirty classrooms with a total of 60 children with ASD (aged 3 - 10 years) will be enrolled in the study. Each classroom will be randomly assigned to either the innovative strategy group or the standard behavioral group. The innovative strategy employs an electronic moisture pager that sends a signal when the child begins having a urine accident. Outcome measures include rate of urine accidents and rate of toilet use in the two groups.
Read the detailed description
The goals of this proposed study is to develop a teacher-mediated model of toileting instruction for children with ASD in school settings that incorporates our innovative manualized moisture pager intervention (i.e., the MP intervention) and conduct a randomized controlled trial (RCT) to compare the efficacy of the MP intervention with a standard behavioral treatment (SBT).
The specific aims and related hypotheses of this proposed study are:
Aim 1: To prepare the teacher-mediated moisture pager (MP) intervention for large-scale testing in classroom settings by modifying the current parent manual for classroom use and evaluating the feasibility of the study protocol.
Hypothesis 1. The study protocol will be feasible, as indicated by achievement of recruitment targets, successful randomization, and 80% retention of both participating classroom staff and children with ASD with complete data collection.
Hypothesis 2. Teachers will deliver MP and standard behavioral treatment (SBT) intervention with >80% fidelity (as rated from teacher training fidelity checklists), and teachers in the MP and SBT intervention groups will adhere to the intervention with >80% fidelity (as rated from treatment fidelity checklists).
Hypothesis 3. Teachers participating in the MP group will report greater satisfaction with MP toilet training experience than teachers participating in the SBT group, based on teacher satisfaction surveys.
Aim 2: To compare the efficacy of the MP intervention and SBT by conducting an RCT (N= 30 classrooms with a total of 60 children with ASD aged 3 - 10 years).
Hypothesis 4. At the close of a 3-month intervention period, children in the MP group will have fewer toileting accidents and higher rate of toilet use for urination than children in the SBT group, based on data collected by teachers on pen-and-paper toileting data logs.
Hypothesis 5. At 3 months following the close of intervention, teachers in the MP group will report fewer toileting accidents and a higher rate of toileting success than children in the SBT group, as indicated through completion of toileting data logs for 3 consecutive days.
- Conditions
- Autistic Disorder, Enuresis
- Being tested
- Moisture Pager Intervention for Toilet Training, Standard of Care
- Medical subject headings
- Autistic Disorder, Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisture Pager Intervention for Toilet TrainingBehavioural
Standard of CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Moisture Pager (MP) Intervention Group | Experimental | This group receives the innovative toilet training intervention comprised of a wireless moisture pager (i.e., an app based on an iPod that "communicates" via electronic signal with a disposable moisture sensor located in the child's underwear). Receives: Behavioral: Moisture Pager Intervention for Toilet Training |
| Standard Behavioral Intervention Group | Active comparator | This group receives standard-of-care intervention as presented in the Autism Treatment Network's Toilet Training Tool Kit (https://www.autismspeaks.org/site-wide/atn-tool-kits). Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teacher Satisfaction with Toilet Training Experience (teacher satisfaction survey)
A teacher satisfaction survey will be completed by each participating teacher following implementation of the intervention for 60 consecutive school days.
Measured: 60 Consecutive School Days
Number of Toileting Accidents/Day and Number of Successful Toilet Use for Urination/Day at End of Treatment (Toileting Data Logs)
Toileting Data Logs will be completed by participating teachers during 3 consecutive days immediately prior to each of 4 visits with study personnel for both groups.
Measured: 60 Consecutive School Days
Number of Toileting Accidents/Day and Number of Successful Toilet Use (3-Month Follow-Up) (Toileting Data Logs)
Toileting Data Logs will be completed by participating teachers during 3 consecutive days immediately prior to a follow-up appointment at 3-months following close of intervention for both groups.
Measured: Collected 3 Calendar Months After End of Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startSep 2014
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, Vanderbilt University
- Responsible party
- Principal investigator, Daniel Mruzek, University of Rochester
- Investigators
- Daniel W Mruzek, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369445
- Sponsor's protocol ID
- 1 R40 MC27705-01-00
- Status last verified
- Oct 2017
- First submitted
- 16 Feb 2015
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
- ClinicalTrials.gov ID
- NCT02369445
- Acronym / sponsor ID
- 1 R40 MC27705-01-00
- Conditions
- Autistic Disorder, Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, Vanderbilt University
- Study start
- Sep 2014
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 24 Feb 2015 (estimated)
- 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.
The purpose of this pilot study is to compare an innovative toilet training strategy with a standard behavioral intervention in children with autism spectrum disorder (ASD), as implemented by teachers in the school setting. Thirty classrooms with a total of 60 children with ASD (aged 3 - 10 years) will be enrolled in the study. Each classroom will be randomly assigned to either the innovative strategy group or the standard behavioral group. The innovative strategy employs an electronic moisture pager that sends a signal when the child begins having a urine accident. Outcome measures include rate of urine accidents and rate of toilet use in the two groups.
Detailed description
The goals of this proposed study is to develop a teacher-mediated model of toileting instruction for children with ASD in school settings that incorporates our innovative manualized moisture pager intervention (i.e., the MP intervention) and conduct a randomized controlled trial (RCT) to compare the efficacy of the MP intervention with a standard behavioral treatment (SBT).
The specific aims and related hypotheses of this proposed study are:
Aim 1: To prepare the teacher-mediated moisture pager (MP) intervention for large-scale testing in classroom settings by modifying the current parent manual for classroom use and evaluating the feasibility of the study protocol.
Hypothesis 1. The study protocol will be feasible, as indicated by achievement of recruitment targets, successful randomization, and 80% retention of both participating classroom staff and children with ASD with complete data collection.
Hypothesis 2. Teachers will deliver MP and standard behavioral treatment (SBT) intervention with >80% fidelity (as rated from teacher training fidelity checklists), and teachers in the MP and SBT intervention groups will adhere to the intervention with >80% fidelity (as rated from treatment fidelity checklists).
Hypothesis 3. Teachers participating in the MP group will report greater satisfaction with MP toilet training experience than teachers participating in the SBT group, based on teacher satisfaction surveys.
Aim 2: To compare the efficacy of the MP intervention and SBT by conducting an RCT (N= 30 classrooms with a total of 60 children with ASD aged 3 - 10 years).
Hypothesis 4. At the close of a 3-month intervention period, children in the MP group will have fewer toileting accidents and higher rate of toilet use for urination than children in the SBT group, based on data collected by teachers on pen-and-paper toileting data logs.
Hypothesis 5. At 3 months following the close of intervention, teachers in the MP group will report fewer toileting accidents and a higher rate of toileting success than children in the SBT group, as indicated through completion of toileting data logs for 3 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moisture Pager (MP) Intervention Group | Experimental | Behavioral: Moisture Pager Intervention for Toilet TrainingThis group receives the innovative toilet training intervention comprised of a wireless moisture pager (i.e., an app based on an iPod that "communicates" via electronic signal with a disposable moisture sensor located in the child's underwear). |
| Standard Behavioral Intervention Group | Active comparator | Behavioral: Standard of CareThis group receives standard-of-care intervention as presented in the Autism Treatment Network's Toilet Training Tool Kit (https://www.autismspeaks.org/site-wide/atn-tool-kits). |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ASD diagnosis confirmed through administration of the ADOS-2,
- status consistent with DSM-5 diagnosis of primary daytime enuresis, with the exception of DSM-5 criterion that child is at least 5 years old, confirmed by the K-SADS,
- a positive determination of readiness for toilet training, as determined through a Toileting Readiness Checklist, developed through a review of relevant literature on toilet training children with ASD (with 4 out of 7 signs in the checklist, with 3 of these criteria required),
- not on medication or stable for the past three months with no anticipated changes during the three-month intervention period, and
- consent from participating teachers and parents.
Key exclusion criteria (3 listed)
- medical conditions that would interfere with toilet training procedures and are not well controlled (e.g., diabetes, urinary tract infection, or seizures),
- physical disorder that may contribute to incontinence (e.g., physical disabilities, chronic constipation) and
- medication for enuresis.
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 |
|---|---|---|
| Moisture Pager Intervention for Toilet Training | Behavioural | Moisture Pager (MP) Intervention Group |
| Standard of Care | Behavioural | Standard Behavioral Intervention Group |
Primary outcome
Teacher Satisfaction with Toilet Training Experience (teacher satisfaction survey)
Time frame: 60 Consecutive School Days
A teacher satisfaction survey will be completed by each participating teacher following implementation of the intervention for 60 consecutive school days.
Number of Toileting Accidents/Day and Number of Successful Toilet Use for Urination/Day at End of Treatment (Toileting Data Logs)
Time frame: 60 Consecutive School Days
Toileting Data Logs will be completed by participating teachers during 3 consecutive days immediately prior to each of 4 visits with study personnel for both groups.
Number of Toileting Accidents/Day and Number of Successful Toilet Use (3-Month Follow-Up) (Toileting Data Logs)
Time frame: Collected 3 Calendar Months After End of Intervention
Toileting Data Logs will be completed by participating teachers during 3 consecutive days immediately prior to a follow-up appointment at 3-months following close of intervention for both groups.
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 Nov 2018.
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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.
Daniel W Mruzek, PhD principal investigator
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisture Pager Intervention for Toilet Training in people with Autistic Disorder and Enuresis, run by University of Rochester at 3 sites in United States.
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 6 inclusion and 3 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Teacher Satisfaction with Toilet Training Experience (teacher satisfaction survey) (time frame: 60 Consecutive School Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2018.