Autism Spectrum DisorderNCT05092321
Aquatic Therapy for ASD
A study testing Aquatic Occupational Therapy in people with Autism Spectrum Disorder, run by Ohio State University at 1 site in United States.
Trial summary
This is an aquatic occupational therapy group for children between the ages of 3-12 that have an autism diagnosis. Intervention will focus on increasing the child's safety swim skills. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Aquatic Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- pre-existing diagnosis of autism spectrum disorder from a medical professional
- family interest in swimming
Who cannot join
- ventilation system for breathing such as trachea not capped
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of Aquatic Therapy in Children With Autism and Their Families
This is an aquatic occupational therapy group for children between the ages of 3-12 that have an autism diagnosis. Intervention will focus on increasing the child's safety swim skills.
Read the detailed description
Information will be collected from participants' guardians during an intake visit regarding a child's sensory processing deficits, movement abilities and exposure to swim skill instruction prior to the group. The group will provide swim instruction using the Halliwick approach to learning swim skills as well as other occupational therapy techniques such as shaping, therapeutic relationship and behavior management. Groups will have a minimum ratio of 1 staff to every 2 children, with the possibility of 1:1 ratio most days. There will be a certified lifeguard present at all times. Qualitative interviews and a follow up survey will be conducted with parents (ages 18+) to determine impact on families and individual participants. Swim skills will be tracked at each session via goal attainment scaling and daily documentation. Descriptive and correlational statistics will be completed as well as coding of interview and survey data. Participants can participate for one, 10 week session, or will have the option to participate in additional 10 week sessions until child participants top out on the WOTA or plateau in progress of swim skills.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Aquatic Occupational Therapy
- 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.
Aquatic Occupational TherapyBehavioural
Group of 4-8 children, paired with a swim buddy. Intervention techniques including discrete teaching, motor shaping, behavioral management, therapeutic relationship and individualized goals.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Occupational Therapy | Experimental | Group-based aquatic occupational therapy with 1:1 swim buddy for safety. Receives: Behavioral: Aquatic Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in swim skills
Change in swim skills measured with Water Orientation Test-Alyn; higher scores mean a better outcome. Minimum score is 0, maximum is 27
Measured: baseline, pre-intervention; immediately after the intervention
Change in individualized goals
Goal Attainment Scaling to track change in other swim performance skills not measured above. Scores for each goal range from -2 (regression) to +2 (2 levels more than anticipated). A higher score indicates improvement.
Measured: immediately after the intervention
Change in parent comfort
Custom questionnaire using 5 point Likert scale regarding comfort and importance of water participation for the child. A higher score indicates increased parent comfort, which is the desirable direction.
Measured: baseline pre-intervention; immediately after the intervention
Parent perspective
qualitative interview regarding parent perspective of the the intervention
Measured: one time after 8 hours of intervention have been provided to the child participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start14 Sep 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Franklin County Board of Developmental Disabilities
- Responsible party
- Principal investigator, Erika Kemp, Ohio State University
- Investigators
- Erika Kemp, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092321
- Sponsor's protocol ID
- 2019J0204
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Aquatic Therapy in Children With Autism and Their Families
- ClinicalTrials.gov ID
- NCT05092321
- Acronym / sponsor ID
- 2019J0204
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Franklin County Board of Developmental Disabilities
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 25 Oct 2021 (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.
This is an aquatic occupational therapy group for children between the ages of 3-12 that have an autism diagnosis. Intervention will focus on increasing the child's safety swim skills.
Detailed description
Information will be collected from participants' guardians during an intake visit regarding a child's sensory processing deficits, movement abilities and exposure to swim skill instruction prior to the group. The group will provide swim instruction using the Halliwick approach to learning swim skills as well as other occupational therapy techniques such as shaping, therapeutic relationship and behavior management. Groups will have a minimum ratio of 1 staff to every 2 children, with the possibility of 1:1 ratio most days. There will be a certified lifeguard present at all times. Qualitative interviews and a follow up survey will be conducted with parents (ages 18+) to determine impact on families and individual participants. Swim skills will be tracked at each session via goal attainment scaling and daily documentation. Descriptive and correlational statistics will be completed as well as coding of interview and survey data. Participants can participate for one, 10 week session, or will have the option to participate in additional 10 week sessions until child participants top out on the WOTA or plateau in progress of swim skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquatic Occupational Therapy | Experimental | Behavioral: Aquatic Occupational TherapyGroup-based aquatic occupational therapy with 1:1 swim buddy for safety. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- pre-existing diagnosis of autism spectrum disorder from a medical professional
- family interest in swimming
Key exclusion criteria (1 listed)
- ventilation system for breathing such as trachea not capped
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 |
|---|---|---|
| Aquatic Occupational TherapyGroup of 4-8 children, paired with a swim buddy. Intervention techniques including discrete teaching, motor shaping, behavioral management, therapeutic relationship and individualized goals. | Behavioural | Aquatic Occupational Therapy |
Primary outcome
Change in swim skills
Time frame: baseline, pre-intervention; immediately after the intervention
Change in swim skills measured with Water Orientation Test-Alyn; higher scores mean a better outcome. Minimum score is 0, maximum is 27
Change in individualized goals
Time frame: immediately after the intervention
Goal Attainment Scaling to track change in other swim performance skills not measured above. Scores for each goal range from -2 (regression) to +2 (2 levels more than anticipated). A higher score indicates improvement.
Change in parent comfort
Time frame: baseline pre-intervention; immediately after the intervention
Custom questionnaire using 5 point Likert scale regarding comfort and importance of water participation for the child. A higher score indicates increased parent comfort, which is the desirable direction.
Parent perspective
Time frame: one time after 8 hours of intervention have been provided to the child participant
qualitative interview regarding parent perspective of the the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No. De-identified data may be shared with other researchers.
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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.
Erika Kemp principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Occupational Therapy in people with Autism Spectrum Disorder, 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 2 inclusion and 1 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 13 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in swim skills (time frame: baseline, pre-intervention; immediately after the intervention). The study lists 4 primary outcomes in all. 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 13 Dec 2024.