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

NCT ID: NCT02369445

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moisture Pager (MP) Intervention Group

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).

Group Type: EXPERIMENTAL

Moisture Pager Intervention for Toilet Training

Intervention Type: BEHAVIORAL

Standard Behavioral Intervention Group

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).

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Interventions

Moisture Pager Intervention for Toilet Training

Intervention Type: BEHAVIORAL

Standard of Care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. ASD diagnosis confirmed through administration of the ADOS-2,

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,

3. 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),

4. not on medication or stable for the past three months with no anticipated changes during the three-month intervention period, and

5. consent from participating teachers and parents.

Exclusion Criteria

1. medical conditions that would interfere with toilet training procedures and are not well controlled (e.g., diabetes, urinary tract infection, or seizures),

2. physical disorder that may contribute to incontinence (e.g., physical disabilities, chronic constipation) and

3. medication for enuresis.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Daniel Mruzek

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel W Mruzek, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Whitney Loring

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

1 R40 MC27705-01-00

Identifier Type: -

Identifier Source: org_study_id