Autism Spectrum DisordersNCT07076264
Water Competency Intervention in Autism
A study testing AquOTic in people with Autism Spectrum Disorders, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- AquOTic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Educational or medical diagnosis of autism
- Age between 5 - 9 years
- Having vision and hearing within normal limits with or without corrective modifications
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Erika Kemp, OTD, (608) 335 - 9230, erika.kemp@osumc.edu
Jewel Crasta, PhD
About this study
Official title: Water Competency Intervention for Children on the Autism Spectrum: The AquOTic Hybrid Effectiveness Implementation Trial
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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- AquOTic
- Keywords
- Swim Safety, Water Competency, Occupational Therapy, AquOTic, Drowning Prevention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquOTicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: AquOTic |
| 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). Receives: Other: AquOTic |
| Control Group | No intervention | Participants will NOT receive AquOTic intervention and will engage in usual and customary water exposure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water Orientation Test-Alyn (WOTA) 2
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.
Measured: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic
Secondary outcomes (3)
Water Orientation Test-Alyn (WOTA) 1
WOTA1 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. WOTA1 assesses 13 swim skills on a 1-4 scale with a minimal detectable change score of 4.5.
Measured: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic
Water Competency Checklist (WCC)
WCC was developed by the AquOTic team and incorporates additional skills not on the WOTA that are considered necessary for water competence. These include jumping in and resurfacing, treading water, and turning around in the water. This checklist is a compilation of items from other swim checklists such as those used by the American Red Cross and clinical trials of swim interventions in autism
Measured: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic
Canadian Occupational Performance Measure (COPM)
COPM is an individualized standardized outcome measure sensitive to change in performance over time. The COPM has been adapted for use in pediatric clinical trials for caregivers of children with disabilities. This measure will be administered by an occupational therapist via a semi-structured interview in which caregivers will identify 3-5 functional goals related to swim performance and water safety. Caregivers will rate how well their child performed each goal (COPM - Performance), and how satisfied they are with their child's performance (COPM - Satisfaction). The same caregiver will be interviewed at pre- and post-test assessments for the AquOTic program. A change of 2 or more points in each scale of the COPM is considered a minimum clinically important difference (MCID). The adapted COPM has high internal consistency (.86 - .88) with content and construct validity.
Measured: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start19 Sep 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a hybrid Type I efficacy-implementation design, aiming to evaluate both the effectiveness of the AquOTic intervention and to advance the science of implementation. While hybrid Type I trials traditionally emphasize clinical effectiveness, this study extends beyond identifying implementation barriers and facilitators by preliminarily assessing proposed implementation mechanisms. Specifically, it will examine therapeutic alliance and attitudes toward the AquOTic intervention as hypothesized factors associated with high intervention fidelity. The trial will utilize a single-blinded, randomized controlled trial (RCT) design, with participants randomly assigned to one of three study arms: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention, while outcomes assessors will remain blinded to group assignment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jewel Crasta, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076264
- Sponsor's protocol ID
- STUDY20250101
- Other IDs
- E06288.1a
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified data on outcome measures with the NIH National Database of Autism Research (NDAR). A README file and data dictionary will be generated and deposited into the NDA repository along with all shared datasets to facilitate the interpretation and reuse of the data. The README file will include the study protocol and data dictionary. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) will be collected for each participant. During study enrollment, we will collect name, date of birth, gender, and town/municipality of birth for all participants to facilitate the creation of a GUID for each participant. Information about NDA data sharing will be included in the consent documentation for the study to allow participants to choose whether they wish to consent to data sharing through NDA.
Publications
Kemp E, Nikahd M, Howard M, Darragh A, Crasta JE. Improving water competency among children on the autism spectrum: the AquOTic randomized controlled trial. Front Pediatr. 2024 Oct 7;12:1473328. doi: 10.3389/fped.2024.1473328. eCollection 2024.
PubMed 39435387Kemp E, Juckett L, Sansone IO, Walton KM, Palettas M, Carson TB, Crasta JE. AquOTic: protocol for a type 1 hybrid effectiveness-implementation trial of an occupational therapy-based water competency intervention for children on the autism spectrum. BMJ Open. 2026 Aug 4;16(8):e117908. doi: 10.1136/bmjopen-2026-117908.
PubMed 42552003
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Competency Intervention for Children on the Autism Spectrum: The AquOTic Hybrid Effectiveness Implementation Trial
- ClinicalTrials.gov ID
- NCT07076264
- Acronym / sponsor ID
- STUDY20250101
- Conditions
- Autism Spectrum Disorders
- Keywords
- Swim Safety, Water Competency, Occupational Therapy, AquOTic, Drowning Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study employs a hybrid Type I efficacy-implementation design, aiming to evaluate both the effectiveness of the AquOTic intervention and to advance the science of implementation. While hybrid Type I trials traditionally emphasize clinical effectiveness, this study extends beyond identifying implementation barriers and facilitators by preliminarily assessing proposed implementation mechanisms. Specifically, it will examine therapeutic alliance and attitudes toward the AquOTic intervention as hypothesized factors associated with high intervention fidelity. The trial will utilize a single-blinded, randomized controlled trial (RCT) design, with participants randomly assigned to one of three study arms: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention, while outcomes assessors will remain blinded to group assignment.
| Arm | Type | Receives |
|---|---|---|
| AquOTic with Professional Student Interventionist | Experimental | Other: AquOTicParticipants 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). |
| AquOTic with Community Interventionists | Experimental | Other: AquOTicParticipants 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). |
| Control Group | No intervention | –Participants will NOT receive AquOTic intervention and will engage in usual and customary water exposure. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Educational or medical diagnosis of autism
- Age between 5 - 9 years
- Having vision and hearing within normal limits with or without corrective modifications
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| AquOTicAquOTic 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. | Other | AquOTic with Community Interventionists, AquOTic with Professional Student Interventionist |
Primary outcome
Water Orientation Test-Alyn (WOTA) 2
Time frame: 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.
3 secondary outcomes
Water Orientation Test-Alyn (WOTA) 1
Time frame: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic
Water Competency Checklist (WCC)
Time frame: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic
Canadian Occupational Performance Measure (COPM)
Time frame: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Results publication: PubMed 39435387Kemp E, Nikahd M, Howard M, Darragh A, Crasta JE. Improving water competency among children on the autism spectrum: the AquOTic randomized controlled trial. Front Pediatr. 2024 Oct 7;12:1473328. doi: 10.3389/fped.2024.1473328. eCollection 2024.
- Derived from this study: PubMed 42552003Kemp E, Juckett L, Sansone IO, Walton KM, Palettas M, Carson TB, Crasta JE. AquOTic: protocol for a type 1 hybrid effectiveness-implementation trial of an occupational therapy-based water competency intervention for children on the autism spectrum. BMJ Open. 2026 Aug 4;16(8):e117908. doi: 10.1136/bmjopen-2026-117908.
- Individual participant dataSharing planned: Yes. We will share de-identified data on outcome measures with the NIH National Database of Autism Research (NDAR). A README file and data dictionary will be generated and deposited into the NDA repository along with all shared datasets to facilitate the interpretation and reuse of the data. The README file will include the study protocol and data dictionary. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) will be collected for each participant. During study enrollment, we will collect name, date of birth, gender, and town/municipality of birth for all participants to facilitate the creation of a GUID for each participant. Information about NDA data sharing will be included in the consent documentation for the study to allow participants to choose whether they wish to consent to data sharing through NDA.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AquOTic in people with Autism Spectrum Disorders, run by Ohio State University 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jewel Crasta, PhD ((970) 682 - 8031, jewel.crasta@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Water Orientation Test-Alyn (WOTA) 2 (time frame: At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07076264, which also lists 2 linked publications.
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 7 Oct 2026.