Trials / Completed
CompletedNCT01978210
Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 3 Years – 6 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2013-11-07
- Last updated
- 2017-02-24
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01978210. Inclusion in this directory is not an endorsement.