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临床试验/NCT06216613
NCT06216613已完成不适用

Testing Effects of Swim Instruction on Autistic Children's Swimming and Water Safety Skills

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Child Swim Test

研究概览

简要总结

The goal of this clinical trial is to compare the effects of a specialized swimming and water-safety program (Sensory Enhanced Aquatics) and standard swimming lessons for autistic children. The main question[s]it aims to answer are:

  • Do Sensory Enhanced Aquatics and standard swimming lessons improve swimming and water-safety skills of autistic children?
  • Which participant characteristics are associated with the highest post-intervention swim skills and water safety across both groups?

Participants will:

  • Complete questionnaires, motor, and swim tests before the intervention.
  • participate in 16, 30-minute Sensory Enhanced Aquatics lessons.
  • Complete a swim test after the intervention.
  • Complete an interview. Researchers will compare with participation in standard swim lessons to see if which bests teaches swimming and water-safety to autistic children.

详细描述

The investigators will conduct a single blind, randomized controlled pilot trial to test the differential effects of an eight-week (16 lesson) Sensory Enhanced Aquatics intervention and standard swim lessons on attainment of swimming and water safety skills of autistic children. Investigators will enroll 50 autistic children aged 5-9 years who will be randomized 1:1 by minimization to either the Sensory Enhanced Aquatics intervention or standard swim lessons to minimize imbalanced group allocation by autism severity and baseline swim skill. Aim 1 will compare the effects of Sensory Enhanced Aquatics to standard swimming lessons on swimming and water safety skills of autistic children with a swim test based on Red Cross water competency guidelines. Aim 2 will assess which participant characteristics (e.g., age, motor ability, autism severity) are associated with the highest post-intervention swim skills and water safety across both groups to inform who benefits most from swim instruction. Child sex and co-occurring motor impairment will be considered as potential covariates. Data will be collected before swim lessons and after 8 weeks of Sensory Enhanced Aquatics or standard lessons. The investigators hypothesize children in both groups will demonstrate improvement in swimming and water safety skills with greater improvements in the Sensory Enhanced Aquatics group; autism severity and motor ability will have the greatest associations with swim skill in both groups. Our exploratory aim will employ post-intervention semi-structured interviews to explore child, parent, and instructor perspectives about instructional methods most effective for developing swimming and water-safety among autistic children. The information obtained from this study will improve our understanding of the best strategies for swim instruction for autistic children and support our long-term goal to make Sensory Enhanced Aquatics scalable on the national level to prevent drowning of autistic children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The nature of our intervention precludes blinding of the interventionists and participants; however, investigators not involved in the intervention, data analysts and research assistants will be blinded to condition.

入排标准

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

入选标准

  • •Age 5-9 yrs. who have received a clinical diagnosis for autism based on Diagnostic and statistical manual of mental disorders: DSM-5 criteria
  • •A Social Responsiveness Scale-2 (SRS-2) T-score of ≥ 60
  • •Sufficient functional ability to understand directions and communicate preferences (verbally or non-verbally)
  • •Baseline swim test score ≤22
  • •No plans to relocate outside the study area during the intervention period.
  • •Physician consent.

排除标准

  • •Uncontrolled epilepsy, as seizures increase risk of drowning.
  • •Baseline swim test score ≥23
  • •Aggressive behaviors that would put instructor safety at risk.

研究组 & 干预措施

Sensory Enhanced Aquatics

Experimental

Sensory Enhanced Aquatics is a specialized swimming and water safety program for autistic children.

干预措施: Sensory Enhanced Aquatics (Behavioral)

Standard Swim Lessons

Active Comparator

Standard swim lessons which are provided to the general public will be used as the comparison group.

干预措施: Standard Swim Lessons (Behavioral)

结局指标

主要结局

Child Swim Test

时间窗: Test was administered pre and post 8 week intervention. The results show the mean change from pre to post test for the 2 arms (SEA and standard lessons)

This measure was created and validated specifically for this study. The unabbreviated scale title is Chil Swim Test. The is an individual performance test of 5 American Red Cross water competency skills, 5 preparatory swim skills and 2 water-safety skills scored on a 4-point scale with total scores ranging from minimum 0 to maximum 38. Higher scores reflect greater skills competence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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