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

NCT01978210 | Completed

• 1 other identifier: Moisture Pager Intervention
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism; Enuresis; Incontinence

Keywords

autism; enuresis; toilet-training

Outcome Measures

Primary Outcomes (4)

• Total number of participants successfully recruited

  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.

  3-month intervention

• Percentage of participants retained across the life of the study

  80% retention across the life of the study will be considered evidence of satisfactory retention of participating families.

  3 months

• Treatment Fidelity (Interventionists)

  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.

  3 months

• Fidelity of Parent Implementation

  Using fidelity checklists, interventionists will rate parents' participation in toilet training intervention, as well as their fidelity to the key components of the intervention.

  3 Months

Secondary Outcomes (3)

• Rate of toileting accidents

  6 months

• Participants' Daily Rate of Toilet Use for Urination

  6 months

• Parent Satisfaction with Toilet Training Intervention

  6 months

Study Arms (2)

Wireless Moisture Pager

EXPERIMENTAL

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.

Device: Wireless Moisture Pager (WMP)

Standard Behavioral Treatment

ACTIVE COMPARATOR

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.

Device: Wireless Moisture Pager (WMP)

Interventions

Wireless Moisture Pager (WMP) DEVICE

The WMP is composed of a three key components: (1) the disposable sensor; (2) the transmitter; and (3) the receiver. The disposable sensor is placed by the parent in the child's underwear and detects small amounts of urine. The transmitter is housed in hardened plastic, attached to the disposable sensor, and, upon activation, emits a radio signal to the receiver. The receiver is an iPod-based app that emits an audible and/or vibration signal to the parent and child at the onset of a toileting accident. A step-by-step manualized curriculum is used to teach parents how to incorporate the device in the toilet training of their child.

Standard Behavioral Treatment; Wireless Moisture Pager

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3-6 years old
• ASD diagnosis confirmed by licensed professional through administration of the ADOS or ADOS-2, depending upon availability of data
• 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
• 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).
• Consent from parent

You may not qualify if:

• Medical conditions that would interfere with toilet training procedures (e.g., physical disabilities)
• Physical disorder that may contribute to incontinence (e.g., diabetes, urinary tract infection, or seizures)
• Anticipation of medication changes to occur during the 3-month intervention period
• Medication for enuresis
• 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).
• 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.
• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Autism Treatment Network: collaborator

Study Sites (3)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43210, United States

Location

Whitney Loring

Nashville, Tennessee, 37235, United States

Location

Related Publications (1)

• Mruzek DW, McAleavey S, Loring WA, Butter E, Smith T, McDonnell E, Levato L, Aponte C, Travis RP, Aiello RE, Taylor CM, Wilkins JW, Corbett-Dick P, Finkelstein DM, York AM, Zanibbi K. A pilot investigation of an iOS-based app for toilet training children with autism spectrum disorder. Autism. 2019 Feb;23(2):359-370. doi: 10.1177/1362361317741741. Epub 2017 Dec 7.

  PMID: 29212345 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Enuresis

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders

Study Officials

• Daniel W Mruzek, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 7, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (3)