Autistic Disorder Clinical Trial
Official title:
Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
Verified date | October 2017 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot study is to compare an innovative toilet training strategy with a standard behavioral intervention in children with autism spectrum disorder (ASD), as implemented by teachers in the school setting. Thirty classrooms with a total of 60 children with ASD (aged 3 - 10 years) will be enrolled in the study. Each classroom will be randomly assigned to either the innovative strategy group or the standard behavioral group. The innovative strategy employs an electronic moisture pager that sends a signal when the child begins having a urine accident. Outcome measures include rate of urine accidents and rate of toilet use in the two groups.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 10 Years |
Eligibility |
Inclusion Criteria: Inclusion criteria for participating children are as follows: 1. ASD diagnosis confirmed through administration of the ADOS-2, 2. status consistent with DSM-5 diagnosis of primary daytime enuresis, with the exception of DSM-5 criterion that child is at least 5 years old, confirmed by the K-SADS, 3. a positive determination of readiness for toilet training, as determined through a Toileting Readiness Checklist, developed through a review of relevant literature on toilet training children with ASD (with 4 out of 7 signs in the checklist, with 3 of these criteria required), 4. not on medication or stable for the past three months with no anticipated changes during the three-month intervention period, and 5. consent from participating teachers and parents. Exclusion Criteria: Exclusion criteria are: 1. medical conditions that would interfere with toilet training procedures and are not well controlled (e.g., diabetes, urinary tract infection, or seizures), 2. physical disorder that may contribute to incontinence (e.g., physical disabilities, chronic constipation) and 3. medication for enuresis. |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Nationwide Children's Hospital, Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Teacher Satisfaction with Toilet Training Experience (teacher satisfaction survey) | A teacher satisfaction survey will be completed by each participating teacher following implementation of the intervention for 60 consecutive school days. | 60 Consecutive School Days | |
Primary | Number of Toileting Accidents/Day and Number of Successful Toilet Use for Urination/Day at End of Treatment (Toileting Data Logs) | Toileting Data Logs will be completed by participating teachers during 3 consecutive days immediately prior to each of 4 visits with study personnel for both groups. | 60 Consecutive School Days | |
Primary | Number of Toileting Accidents/Day and Number of Successful Toilet Use (3-Month Follow-Up) (Toileting Data Logs) | Toileting Data Logs will be completed by participating teachers during 3 consecutive days immediately prior to a follow-up appointment at 3-months following close of intervention for both groups. | Collected 3 Calendar Months After End of Intervention |
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