AutismNCT06216613
Testing Swim Instruction for Autistic Children
A study testing Sensory Enhanced Aquatics and Standard Swim Lessons in people with Autism, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Autism
- What is being tested?
- Sensory Enhanced Aquatics and Standard Swim Lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2024to 4 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Uncontrolled epilepsy, as seizures increase risk of drowning.
- Baseline swim test score ≥23
- Aggressive behaviors that would put instructor safety at risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Testing Effects of Swim Instruction on Autistic Children's Swimming and Water Safety Skills
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?
Read more
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Sensory Enhanced Aquatics, Standard Swim Lessons
- Keywords
- Autism, Water Safety, Swimming
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Enhanced AquaticsBehavioural
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.
Standard Swim LessonsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Enhanced Aquatics | Experimental | Sensory Enhanced Aquatics is a specialized swimming and water safety program for autistic children. Receives: Behavioral: Sensory Enhanced Aquatics |
| Standard Swim Lessons | Active comparator | Standard swim lessons which are provided to the general public will be used as the comparison group. Receives: Behavioral: Standard Swim Lessons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Swim Test
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start14 Apr 2024
- Primary completion31 Jul 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216613
- Sponsor's protocol ID
- FP00000742
- Other IDs
- R21HD111917
- Status last verified
- Jul 2026
- First submitted
- 11 Jan 2024
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data will be preserved at the local site per local institutional policies and guidelines. However, the data that will be preserved and made available for sharing will be the summary or scored data for each participant at each data collection timepoint. We have made this decision to provide summary or scored data to allow for the data that are available to be consistent across the various uses (e.g., to minimize the likelihood of scoring errors by others who may use the data). However, if the study sponsor or other regulatory entity requests that we reconsider this decision, we are willing to consider this request. We will also share audio recordings of interviews.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Effects of Swim Instruction on Autistic Children's Swimming and Water Safety Skills
- ClinicalTrials.gov ID
- NCT06216613
- Acronym / sponsor ID
- FP00000742
- Conditions
- Autism
- Keywords
- Autism, Water Safety, Swimming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Posted 12 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sensory Enhanced Aquatics | Experimental | Behavioral: Sensory Enhanced AquaticsSensory Enhanced Aquatics is a specialized swimming and water safety program for autistic children. |
| Standard Swim Lessons | Active comparator | Behavioral: Standard Swim LessonsStandard swim lessons which are provided to the general public will be used as the comparison group. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Uncontrolled epilepsy, as seizures increase risk of drowning.
- Baseline swim test score ≥23
- Aggressive behaviors that would put instructor safety at risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Enhanced AquaticsSensory 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. | Behavioural | Sensory Enhanced Aquatics |
| Standard Swim LessonsStandard 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. | Behavioural | Standard Swim Lessons |
Primary outcome
Child Swim Test
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The raw data will be preserved at the local site per local institutional policies and guidelines. However, the data that will be preserved and made available for sharing will be the summary or scored data for each participant at each data collection timepoint. We have made this decision to provide summary or scored data to allow for the data that are available to be consistent across the various uses (e.g., to minimize the likelihood of scoring errors by others who may use the data). However, if the study sponsor or other regulatory entity requests that we reconsider this decision, we are willing to consider this request. We will also share audio recordings of interviews.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Enhanced Aquatics and Standard Swim Lessons in people with Autism, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Swim Test (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.