跳至主要内容
临床试验/NCT07076264
NCT07076264招募中不适用

Water Competency Intervention for Children on the Autism Spectrum: The AquOTic Hybrid Effectiveness Implementation Trial

Ohio State University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
108
试验地点
1
主要终点
Water Orientation Test-Alyn (WOTA) 2

研究概览

简要总结

AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist.

Overall, this study has 3 major aims. The first aim evaluates the effectiveness of the AquOTic intervention in improving water competency and swim skills, while comparing outcomes between two implementation models: professional student interventionists (occupational and physical therapy students) and trained community-based interventionists. A total of 108 autistic children will be enrolled and randomly assigned to one of three groups: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention. The second aim explores the mediators and moderators of the intervention outcomes to assess fidelity and efficacy. The third aim identifies the cost and resources associated with AquOTic. A cost analysis will be conducted to evaluate the resources required for implementation and to inform the development of a scalable, cost-effective drowning prevention strategy for autistic populations.

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)

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

  • •Children Participants (n=108)
  • •Inclusion Criteria
  • •Educational or medical diagnosis of autism
  • •Age between 5 - 9 years
  • •Having vision and hearing within normal limits with or without corrective modifications

排除标准

  • •Children who demonstrate swim proficiency, as defined by the ability to tread water for 1 minute or move the body through the water without flotation
  • •Open wounds or infectious skin diseases
  • •Allergy to chlorine
  • •Severe co-occurring motor impairments or neurological conditions such as uncontrolled seizures, Rett's or Angelman's syndrome
  • •The family is unable to commit to the sessions or evaluations
  • •Interventionists (n=64)
  • •Inclusion Criteria
  • •Aged 18 or over
  • •Demonstrate swim proficiency, as defined by the ability to tread water for 1 minute and move the body through the water without flotation for 25 yards
  • •Exclusion Criteria
  • •Open wounds or infectious diseases
  • •Failed background check
  • •Unable to commit to Basic Swim Instructor and AquOTic training (~40 hours) and 10 AquOTic sessions (20 hours)

研究组 & 干预措施

AquOTic with Professional Student Interventionist

Experimental

Participants in this arm will participate in the 10-week AquOTic intervention with their one to one interventionists being professional students (OT/PT students currently enrolled at OSU).

干预措施: AquOTic (Other)

AquOTic with Community Interventionists

Experimental

Participants in this arm will participate in the 10-week AquOTic intervention with their one to one interventionists being community interventionists (high school or undergraduate students in the community).

干预措施: AquOTic (Other)

Control Group

No Intervention

Participants will NOT receive AquOTic intervention and will engage in usual and customary water exposure.

结局指标

主要结局

Water Orientation Test-Alyn (WOTA) 2

时间窗: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic

The WOTA2 measures a child's mental adaptation, adjustment to the pool, postural balance, and the ability to move and change position in the water, based on the Halliwick concept. WOTA2 assesses 27 swim skills scored on a 0-3 scale with a minimal detectable change score of 11.5. Higher scores indicate better skills. WOTA2 has high test-retest reliability (ICC=.97) and is validated for children with autism-like characteristics.

次要结局

  • Water Orientation Test-Alyn (WOTA) 1(At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic)
  • Water Competency Checklist (WCC)(At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic)
  • Canadian Occupational Performance Measure (COPM)(At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic)

研究者

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

Jewel Crasta

Assistant Professor

Ohio State University

研究点 (1)

Loading locations...

相似试验