NCT02369445

Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Autistic Disorder
• Enuresis

Interventions

Type	Name	Description
BEHAVIORAL	Moisture Pager Intervention for Toilet Training
BEHAVIORAL	Standard of Care

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2015-02-24
• Last updated: 2018-11-21

Locations

3 sites across 1 country: United States