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临床试验/NCT05524753
NCT05524753已完成不适用

Active Ingredients & Efficacy of AquOTic: Aquatic Occupational Therapy for Children on the Autism Spectrum

Ohio State University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2022年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Change in swim skills

研究概览

简要总结

Accidental drowning is the number one cause of death in children with autism spectrum disorders (ASD) and highlights the critical need for swim lessons and water safety training for this population. Our team has developed and tested an innovative, occupational therapy (OT) based aquatic program - AquOTic - that provides preliminary support for the use of an individualized swim skills training intervention in children with ASD. The AquOTic program uses a combination of sensory, motor learning, and behavioral approaches to improve water safety and swim skills. In this study, we will use a randomized control trial design to identify the efficacy of the AquOTic intervention to improve swim performance in children with ASD.

详细描述

Once enrolled, children will be randomized to one of three groups. Group A will receive the intervention right away. Group B will use a waitlist control for 10 weeks, then will receive the intervention. Group C will be a control group, and will be offered the intervention at the end of the control period. Each group will have 12 participants.

AquOTic a group based aquatic occupational therapy intervention that uses evidence-based therapeutic teaching techniques including therapeutic relationship, grading of activities, shaping, positive reinforcement and individualized goals to direct the intervention.

We will also develop a fidelity measure to operationalize the therapeutic strategies and quantify the active ingredients of the AquOTic program. Our long-term goal is to create evidence for an OT-based swim intervention for children with ASD that has the potential to decrease the drowning risk in this population.

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
Single (Outcomes Assessor)

盲法说明

Outcome assessors are blinded to whether or not the client received the intervention or control/waitlist.

入排标准

年龄范围
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • pre-existing diagnosis of autism & interest in learning to swim

排除标准

  • able to float or move through the water for 5-10 feet without assistance.
  • presence of compromised airway such as trachea or ventilation system
  • other contraindication to submersion in water.

结局指标

主要结局

Change in swim skills

时间窗: baseline, pre-intervention; immediately after the intervention

change in swim skills using Water Orientation Test-Alyn. A higher score means a better outcome. Minimum score 0, maximum score 71.

Questionnaire to track change in parent perception and satisfaction with progress on individualized family-centered goals

时间窗: pre intervention, immediately after the intervention

Canadian Occupational Performance Measure to establish goals with parents and track performance and satisfaction with goals. A higher score indicates higher parent satisfaction and child performance on the goals.

Parent Perspective

时间窗: one time after at least 8 hours of the intervention has been provided to the child

qualitative interview regarding parent perspective of the intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erika Kemp

Assistant Professor, Clinical

Ohio State University

研究点 (2)

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