Autism
Conditions
Keywords
Autism, Water Safety, Swimming
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.
Interventions
BEHAVIORALSensory Enhanced Aquatics
Sensory Enhanced Aquatics (SEA) utilizes the Sensory Profile to individualize lessons based on children's sensory preferences. The program incorporates evidence-based approaches for autistic children, including: 1) visual supports, 2) sensory supports, 3) communication strategies, 4) behavioral strategies, and 5) modeling to maximize skill acquisition. Lessons will be 1:1 with social opportunities at the beginning and end of each lesson. Like standard swim lessons, skills are taught in progression from water orientation (e.g., blowing bubbles, submerging different body parts) to advanced swimming (e.g., swimming 15 or more yards of different swim strokes). All lessons include instruction of water safety skills. Each skill has been task analyzed by therapists so instruction can be graded according to children's ability. A social story is provided to transition children to lessons. SEA curriculum was reviewed by USA Swimming Foundation and is included as a Swim Lesson Network Provider.
BEHAVIORALStandard Swim Lessons
Standard swim lessons will adhere to USA Swimming Foundation Swim Network Provider requirements ensuring lessons meet or exceed industry best practices. Lessons have up to a 1:5 instructor to child ratio and will focus on stroke development and water-safety with skills advancing from water-orientation to stroke technique and endurance.
Sponsors
University of Kansas Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Swim Test | 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. |
Countries
United States
Participant flow
Recruitment details
We distributed information about the study through a university registry and interested participants provided contact information through a secure survey link on the study website April of 2024. The link was closed in the first week of recruitment due to overwhelming response. Screening and enrollment occurred from April 2024 through November 2024.
Pre-assignment details
A biostatistician randomized participants with adaptive 1:1 allocation to one of 2 intervention arms: 1) an 8-week,16 lesson Sensory Enhanced Aquatics swimming intervention or 2) an 8-week, 16 lesson control condition with standard swim lessons. Adaptive randomization was performed using a probabilistic minimization algorithm to reduce imbalance between groups based on autism severity and baseline swimming ability, as these variables were expected to influence the primary outcomes.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Mean Age of Participants | 5.94 years STANDARD_DEVIATION 1.39 |
| Child Swim Test | 13.81 units on a scale STANDARD_DEVIATION 6.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 35 Participants |
| Social Responsiveness Scale-2 Mild Range | 2 Participants |
| Social Responsiveness Scale-2 Moderate Range | 24 Participants |
| Social Responsiveness Scale-2 Severe Range | 12 Participants |
| The Bruininks-Oseretsky Test of Motor Proficiency-2nd Edition Average | 3 Participants |
| The Bruininks-Oseretsky Test of Motor Proficiency-2nd Edition Below Average | 6 Participants |
| The Bruininks-Oseretsky Test of Motor Proficiency-2nd Edition Well Below Average | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 24 |
| other Total, other adverse events | 0 / 27 | 0 / 24 |
| serious Total, serious adverse events | 0 / 27 | 0 / 24 |
Outcome results
None listed