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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978210
• Other study ID #: Moisture Pager Intervention
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: February 23, 2017
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Enuresis
• Incontinence
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Device:
• Wireless Moisture Pager (WMP)
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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Whitney Loring	Nashville	Tennessee
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Autism Treatment Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Rate of toileting accidents	Data logs maintained by parents during the 3 consecutive days prior to office visits will be used to measure toileting accidents. These data will be used to test the hypothesis that the WMP group will have fewer toileting accidents than the SBT group.This will be assessed at 3 months (close of active intervention) and at a 6-month follow-up appointment.	6 months
Secondary	Participants' Daily Rate of Toilet Use for Urination	Toileting logs maintained by parents for 3 consecutive days prior to study visit will be used to measure the daily rate of toilet use for participants. These data will be used to test the hypothesis that children in the WMP group will demonstrate more rapid acquisition of toileting skills than children in the SBT group. This will be assessed at 3 months (close of active intervention) and at a 6-month follow-up appointment.	6 months
Secondary	Parent Satisfaction with Toilet Training Intervention	A parent satisfaction rating scale will be used to measure their satisfaction with their experience with the toilet training intervention for their child. These data will be used to test the hypothesis that parents participating in the WMP intervention will report overall greater satisfaction with their training experience relative to the SBT group. This will be assessed at 3 months (close of active intervention) and at a 6-month follow-up appointment.	6 months