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

Completed · Not applicable

Conditions studied: Autism, Enuresis, Incontinence

In brief

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.

Key facts

Study ID

NCT01978210

Run by

University of Rochester

People needed

31

Starts

2013-09-01

Expected to finish

2015-06-01

Last updated by the study team

2017-02-24

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Whitney Loring — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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