Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism

Not Applicable

Completed

• Conditions: Autism; Enuresis; Incontinence
• Interventions: Device: Wireless Moisture Pager (WMP)

• Registration Number: NCT01978210
• Lead Sponsor: University of Rochester

Brief Summary

This pilot study is designed to investigate the feasibility of comparing a standard behavioral intervention and an innovative intervention that incorporates the use of a wireless moisture alarm in training children with autism how to independently use the toilet for urination. We hypothesize that the study protocol will be feasible, as measured through review of achieved recruitment targets, successful randomization, and \>80% retention of subjects with com- plete data collection. Our second hypothesis is that therapists will deliver experimental and standard behavioral treatment intervention with ≥80% fidelity and parents in both intervention groups will adhere to the intervention with ≥80% fidelity. A secondary aim of this study is to examine trends in outcome data by conducting a small RCT (N = 30) of wireless moisture alarm and standard behavioral toilet training, with the hypothesis that the moisture alarm intervention will result in fewer toileting accidents, a higher rate of toileting success and greater parental satisfaction.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-07
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Age 3-6 years old
2. ASD diagnosis confirmed by licensed professional through administration of the ADOS or ADOS-2, depending upon availability of data
3. Status consistent with DSM-IV (or DSM-V, depending upon availability) diagnostic criteria for primary daytime enuresis (with exception of criterion that child is at least 5 years old), confirmed by the K- SADS
4. A positive determination of readiness for toilet training, as determined through aToileting Readiness Checklist developed through a review of relevant literature on toilet training with children with autism (with 4 or more of 7 signs in the checklist, with 3 of these criteria required).
5. Consent from parent

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Exclusion Criteria

1. Medical conditions that would interfere with toilet training procedures (e.g., physical disabilities)
2. Physical disorder that may contribute to incontinence (e.g., diabetes, urinary tract infection, or seizures)
3. Anticipation of medication changes to occur during the 3-month intervention period
4. Medication for enuresis
5. A parent report that the child has urinated into a toilet 2 times or more when toilet trips are initiated by child, AND/OR 20% or more of the total instances in which a caretaker had initiated a toileting opportunity (to be estimated by study team member during initial conversation. If parent is unsure, they may be asked to monitor toileting behavior for a week, and the team member can call back to review with parent).
6. Parent report that the child has participated in systematic training efforts, under the guidance of a clinician (e.g., physician, psychologist) for more than 8 weeks (total) in the previous 6months.
7. Active drug or alcohol use or dependence on the part of the parent that, in the opinion of the site investigator, would interfere with adherence to study re- quirements.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wireless Moisture Pager	Wireless Moisture Pager (WMP)	Parent(s) of subjects will participate in training and follow-up sessions in a manualized toilet training intervention for their child that incorporates use of a wireless moisture pager.
Standard Behavioral Treatment	Wireless Moisture Pager (WMP)	Parent(s) of subjects will participate in training and follow-up sessions in a toilet training intervention for their child that incorporates use of the Autism Treatment Network's Toilet Training Tool Kit. The Tool Kit is a publication widely available to parents and clinicians that is designed to serve as an aid in the toilet training of children with autism. In this study, it is being used as a standard treatment control.

Primary Outcome Measures

Name	Time	Method
Total number of participants successfully recruited	3-month intervention	As a pilot study, a key outcome variable is the number of families successfully recruited for participation in this study involving intensive toilet training administered by parents.
Percentage of participants retained across the life of the study	3 months	80% retention across the life of the study will be considered evidence of satisfactory retention of participating families.
Treatment Fidelity (Interventionists)	3 months	Digitally recorded 2-hour initial parent training sessions will be scored by independent raters using an intervention fidelity checklist to assess the degree to which interventionists are successful in delivering the treatments. Scores of 80% fidelity will be considered evidence of satisfactory treatment fidelity.
Fidelity of Parent Implementation	3 Months	Using fidelity checklists, interventionists will rate parents' participation in toilet training intervention, as well as their fidelity to the key components of the intervention.

Secondary Outcome Measures

Name	Time	Method
Rate of toileting accidents	6 months	Data logs maintained by parents during the 3 consecutive days prior to office visits will be used to measure toileting accidents. These data will be used to test the hypothesis that the WMP group will have fewer toileting accidents than the SBT group.This will be assessed at 3 months (close of active intervention) and at a 6-month follow-up appointment.
Participants' Daily Rate of Toilet Use for Urination	6 months	Toileting logs maintained by parents for 3 consecutive days prior to study visit will be used to measure the daily rate of toilet use for participants. These data will be used to test the hypothesis that children in the WMP group will demonstrate more rapid acquisition of toileting skills than children in the SBT group. This will be assessed at 3 months (close of active intervention) and at a 6-month follow-up appointment.
Parent Satisfaction with Toilet Training Intervention	6 months	A parent satisfaction rating scale will be used to measure their satisfaction with their experience with the toilet training intervention for their child. These data will be used to test the hypothesis that parents participating in the WMP intervention will report overall greater satisfaction with their training experience relative to the SBT group. This will be assessed at 3 months (close of active intervention) and at a 6-month follow-up appointment.

Trial Locations

Locations (3)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Whitney Loring; 🇺🇸 Nashville, Tennessee, United States