Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
Condition: Autistic Disorder; Enuresis
MeSH terms: Enuresis; Autistic Disorder
Study type: Interventional

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.
    

Intervention name(s): Moisture Pager Intervention for Toilet Training; Standard of Care
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment