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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Rochester
Sponsor:
Collaborator:
Autism Treatment Network
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01978210
First received: October 24, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Autism
Enuresis
Incontinence
Device: Wireless Moisture Pager (WMP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Total number of participants successfully recruited [ Time Frame: 3-month intervention ] [ Designated as safety issue: No ]
    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.

  • Percentage of participants retained across the life of the study [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    80% retention across the life of the study will be considered evidence of satisfactory retention of participating families.

  • Treatment Fidelity (Interventionists) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Fidelity of Parent Implementation [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Using fidelity checklists, interventionists will rate parents' participation in toilet training intervention, as well as their fidelity to the key components of the intervention.


Secondary Outcome Measures:
  • Rate of toileting accidents [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Participants' Daily Rate of Toilet Use for Urination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Parent Satisfaction with Toilet Training Intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wireless Moisture Pager
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.
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.
Active Comparator: Standard Behavioral Treatment
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.
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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978210

Contacts
Contact: Daniel W Mruzek, PhD 1-585-273-5980 Daniel_Mruzek@urmc.rochester.edu
Contact: Stephen McAleavey, PhD 1-585-2757768 stephenm@bme.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Daniel W Mruzek, PhD    585-273-5980    Daniel_Mruzek@urmc.rochester.edu   
Principal Investigator: Daniel W Mruzek, PhD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Eric Butter, PhD    614-247-7349    buttere@chi.osu.edu   
Principal Investigator: Eric Butter, PhD         
United States, Tennessee
Whitney Loring Recruiting
Nashville, Tennessee, United States, 37235
Contact: Whitney A Loring, Psy.D    615-343-6153    whitney.a.loring@vanderbilt.edu   
Principal Investigator: Whitney A Loring, PsyD         
Sponsors and Collaborators
University of Rochester
Autism Treatment Network
Investigators
Principal Investigator: Daniel W Mruzek, PhD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01978210     History of Changes
Other Study ID Numbers: Moisture Pager Intervention
Study First Received: October 24, 2013
Last Updated: October 31, 2013
Health Authority: University of Rochester, RSRB. Rochester, NY, USA:

Keywords provided by University of Rochester:
autism
enuresis
toilet-training

Additional relevant MeSH terms:
Autistic Disorder
Enuresis
Nocturnal Enuresis
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders

ClinicalTrials.gov processed this record on July 20, 2014