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| Name | Class |
|---|---|
| Autism Treatment Network | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wireless Moisture Pager | Experimental | 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. |
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| Standard Behavioral Treatment | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wireless Moisture Pager (WMP) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel W Mruzek, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States | ||
| Nationwide Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29212345 | Derived | 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. |
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Investigators can contact the responsible party to obtain de-identified data.
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D004775 | Enuresis |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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 |
| 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 |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Whitney Loring | Nashville | Tennessee | 37235 | United States |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |