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

University of Rochester

Status: Completed

Conditions: Enuresis; Autism; Incontinence

Treatments: Device: Wireless Moisture Pager (WMP)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01978210

Moisture Pager Intervention

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Wireless Moisture Pager

Experimental group

Description:

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.

Treatment:

Device: Wireless Moisture Pager (WMP)

Standard Behavioral Treatment

Active Comparator group

Description:

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.

Treatment:

Device: Wireless Moisture Pager (WMP)