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



Status:Completed
Conditions:Neurology, Psychiatric, Urology, Autism
Therapuetic Areas:Nephrology / Urology, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:3 - 6
Updated:2/25/2017
Start Date:September 2013
End Date:June 2015

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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.


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.
We found this trial at
3
sites
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Nashville, Tennessee 37235
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Nashville, TN
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