Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Percentage of participants retained across the life of the study
研究概览
简要总结
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.
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 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-6 years old
- •ASD diagnosis confirmed by licensed professional through administration of the ADOS or ADOS-2, depending upon availability of data
- •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
- •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).
- •Consent from parent
排除标准
- •Medical conditions that would interfere with toilet training procedures (e.g., physical disabilities)
- •Physical disorder that may contribute to incontinence (e.g., diabetes, urinary tract infection, or seizures)
- •Anticipation of medication changes to occur during the 3-month intervention period
- •Medication for enuresis
- •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).
- •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.
- •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.
结局指标
主要结局
Percentage of participants retained across the life of the study
时间窗: 3 months
80% retention across the life of the study will be considered evidence of satisfactory retention of participating families.
Total number of participants successfully recruited
时间窗: 3-month intervention
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.
Treatment Fidelity (Interventionists)
时间窗: 3 months
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
时间窗: 3 Months
Using fidelity checklists, interventionists will rate parents' participation in toilet training intervention, as well as their fidelity to the key components of the intervention.
次要结局
- Rate of toileting accidents(6 months)
- Participants' Daily Rate of Toilet Use for Urination(6 months)
- Parent Satisfaction with Toilet Training Intervention(6 months)
研究者
Daniel Mruzek
Associate Professor
University of Rochester