Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
Sponsor: Nationwide Children's Hospital
This NA trial investigates Autistic Disorder and Enuresis and is currently completed. Nationwide Children's Hospital leads this study, which shows 7 recorded versions since 2014 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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...
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed NA
-
Sep 2024 — Present [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
-
Jan 2021 — Jul 2024 [monthly]
Completed NA
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Dec 2018 — Jan 2021 [monthly]
Completed NA
Status: Recruiting → Completed
▶ Show 2 earlier versions
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Jun 2018 — Dec 2018 [monthly]
Recruiting NA
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Jan 2017 — Jun 2018 [monthly]
Recruiting NA
First recorded
Sep 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Nationwide Children's Hospital
- University of Rochester
- Vanderbilt University
For direct contact, visit the study record on ClinicalTrials.gov .