Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Teacher Satisfaction with Toilet Training Experience (teacher satisfaction survey)
研究概览
简要总结
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.
详细描述
The goals of this proposed study is to develop a teacher-mediated model of toileting instruction for children with ASD in school settings that incorporates our innovative manualized moisture pager intervention (i.e., the MP intervention) and conduct a randomized controlled trial (RCT) to compare the efficacy of the MP intervention with a standard behavioral treatment (SBT).
The specific aims and related hypotheses of this proposed study are:
Aim 1: To prepare the teacher-mediated moisture pager (MP) intervention for large-scale testing in classroom settings by modifying the current parent manual for classroom use and evaluating the feasibility of the study protocol.
Hypothesis 1. The study protocol will be feasible, as indicated by achievement of recruitment targets, successful randomization, and 80% retention of both participating classroom staff and children with ASD with complete data collection.
Hypothesis 2. Teachers will deliver MP and standard behavioral treatment (SBT) intervention with >80% fidelity (as rated from teacher training fidelity checklists), and teachers in the MP and SBT intervention groups will adhere to the intervention with >80% fidelity (as rated from treatment fidelity checklists).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for participating children are as follows:
- •ASD diagnosis confirmed through administration of the ADOS-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,
- •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),
- •not on medication or stable for the past three months with no anticipated changes during the three-month intervention period, and
- •consent from participating teachers and parents.
排除标准
- •Exclusion criteria are:
- •medical conditions that would interfere with toilet training procedures and are not well controlled (e.g., diabetes, urinary tract infection, or seizures),
- •physical disorder that may contribute to incontinence (e.g., physical disabilities, chronic constipation) and
- •medication for enuresis.
结局指标
主要结局
Teacher Satisfaction with Toilet Training Experience (teacher satisfaction survey)
时间窗: 60 Consecutive School Days
A teacher satisfaction survey will be completed by each participating teacher following implementation of the intervention for 60 consecutive school days.
Number of Toileting Accidents/Day and Number of Successful Toilet Use for Urination/Day at End of Treatment (Toileting Data Logs)
时间窗: 60 Consecutive School Days
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.
Number of Toileting Accidents/Day and Number of Successful Toilet Use (3-Month Follow-Up) (Toileting Data Logs)
时间窗: Collected 3 Calendar Months After End of Intervention
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.
次要结局
未报告次要终点
研究者
Daniel Mruzek
Associate Professor of Pediatrics
University of Rochester