Clinical trial NCT06216613: Testing Swim Instruction for Autistic Children
Official title: Testing Effects of Swim Instruction on Autistic Children's Swimming and Water Safety Skills
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: Autism
Water Safety
Swimming
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 50 participants who will be randomized 1:1 to either the Sensory Enhanced Aquatics intervention or control condition with standard swim lessons.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Child Swim Test
timeFrame: pre and post 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: