Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
1 other identifier
interventional
60
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedNovember 21, 2018
October 1, 2017
3.8 years
February 16, 2015
November 19, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Collected 3 Calendar Months After End of Intervention
Study Arms (2)
Moisture Pager (MP) Intervention Group
EXPERIMENTALThis 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 COMPARATORThis 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- Nationwide Children's Hospitalcollaborator
- Vanderbilt Universitycollaborator
Study Sites (3)
University of Rochester Medical Center
Rochester, New York, 14642, United States
Nationwide Children's Hospital
Columbus, Ohio, 43210, United States
Whitney Loring
Nashville, Tennessee, 37235, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel W Mruzek, PhD
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
February 16, 2015
First Posted
February 24, 2015
Study Start
September 1, 2014
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
November 21, 2018
Record last verified: 2017-10