Clinical trial NCT01978210: Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism
Official title: Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Enuresis
Incontinence
Keywords: autism
enuresis
toilet-training
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Autism Treatment Network
First posted: 2013-11-07
Enrollment: 31
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total number of participants successfully recruited
timeFrame: 3-month intervention
measure: Percentage of participants retained across the life of the study
timeFrame: 3 months
measure: Treatment Fidelity (Interventionists)
timeFrame: 3 months
measure: Fidelity of Parent Implementation
timeFrame: 3 Months
Secondary outcomes:
measure: Rate of toileting accidents
timeFrame: 6 months
measure: Participants' Daily Rate of Toilet Use for Urination
timeFrame: 6 months
measure: Parent Satisfaction with Toilet Training Intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Nashville
country: United States
facility: Whitney Loring
state: Tennessee
Study officials:
affiliation: University of Rochester
name: Daniel W Mruzek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.