Sensory Processing DisorderNCT06484946
Pediatric Aquatic Occupational Therapy for Children With Sensory Processing Challenges
A study testing aquatic occupational therapy in people with Sensory Processing Disorder and Autism Spectrum Disorder, run by Kristen Pataki at 1 site in United States.
Trial summary
Children with sensory processing challenges participated in an 8-week play-based aquatic program addressing goals on behavior, sensory, and participation. It is expected that after the 8-week group, the child's goals will improve demonstrating an effective intervention to address sensory difficulties. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Sensory Processing Disorder, Autism Spectrum Disorder, ADHD
- What is being tested?
- aquatic occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2019to 9 Apr 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must be ages 4-9 years old
- have an identified sensory processing problem as related on the SPM assessment
- able to maintain head, neck, and trunk control
- able to follow 1-2 step directions
Who cannot join
- Participants younger than 4 years old and older than 9 years old
- requires lift to get in the water
- difficulty with following 1-step directions
Trial locations and contacts
1 site in 1 country.
United States1 site
Seven Hills Recreation Center
Seven Hills, Ohio, 44131
About this study
Children with sensory processing challenges participated in an 8-week play-based aquatic program addressing goals on behavior, sensory, and participation. It is expected that after the 8-week group, the child's goals will improve demonstrating an effective intervention to address sensory difficulties.
Read the detailed description
This study examined the effectiveness of an aquatic OT program for children with sensory processing difficulties to develop water readiness skills and improve sensory, behavior, and engagement goals. Six groups of children with deficits in various sensory systems participated in an 8-week aquatic group led by an occupational therapist and occupational therapy students. Each week consisted of a 45-minute aquatic group with a 5 min warmup on land, 30 mins of aquatic activities addressing the sensory system of the week, and 10 mins addressing a social activity with peers. Goals were developed and assessed via the Goal Attainment Scale (GAS). Parents of the participants were given the Sensory Processing Measure (SPM-2) before beginning. As a result of participating in the aquatic OT intervention, percentage of goals achieved will be analyzed. It is expected that this program proves to be beneficial and therefore aquatic OT shows potential for improving sensory processing skills, behavior, and social participation with peers.
- Conditions
- Sensory Processing Disorder, Autism Spectrum Disorder, ADHD
- Being tested
- aquatic occupational therapy
- Keywords
- aquatic therapy, children, sensory processing challenges, aquatics, water, learn to swim, aquatic occupational therapy, occupational therapy, sensory processing
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic occupational therapyOther
Also called occupational therapy, aquatic therapy, social participation
Each week, the children participated in a 45-minute aquatic occupational therapy group that consisted of warmup on land, 30 mins of sensory activities in the water, and 10 mins of social activity in the water
| Study group | Role | What they receive |
|---|---|---|
| Aquatic occupational therapy | Experimental | Each child participated and experienced occupational therapy in the water. Receives: Other: aquatic occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scaling (GAS)
Goals were written on behavior, engagement/participation, and sensory on a scale from -2 (worse outcome) to +2 (better outcome). Each week scores on each goal were documented.
Measured: Scores were tracked weekly for 8 weeks of each program.
Parent Surveys
Survey with quantitative and qualitative questions about their child's experience and differences seen in the aquatic group
Measured: Parents were given a post-survey at the 8th week.
Secondary outcomes (1)
Sensory Processing Measure (SPM: Preschool version: SPM-P, newer edition: SPM-2) Assessment Scores
Assessment given to parents to fill out before their child could start the aquatic group. Gives information on different sensory systems. Categories are: vision, hearing, touch, taste and smell, body awareness, balance and motion, sensory total, planning and ideas, and social participation. Interpretive range is: Typical, Moderate difficulties, and Severe difficulties.
Measured: Parents completed SPM on their child before the 8-week group began.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start19 Feb 2019
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Processing DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Every participant receives the intervention. Each child participates in the 8-week aquatic group.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristen Pataki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristen Pataki, Cleveland State University
- Investigators
- Kristen M Pataki, OTD, Principal investigator, Cleveland State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484946
- Sponsor's protocol ID
- Cleveland SU
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not sure if other researchers will want access to this data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Aquatic Occupational Therapy for Children With Sensory Processing Challenges
- ClinicalTrials.gov ID
- NCT06484946
- Acronym / sponsor ID
- Cleveland SU
- Conditions
- Sensory Processing Disorder, Autism Spectrum Disorder, ADHD
- Keywords
- aquatic therapy, children, sensory processing challenges, aquatics, water, learn to swim, aquatic occupational therapy, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kristen PatakiUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 3 Jul 2024 (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.
Children with sensory processing challenges participated in an 8-week play-based aquatic program addressing goals on behavior, sensory, and participation. It is expected that after the 8-week group, the child's goals will improve demonstrating an effective intervention to address sensory difficulties.
Detailed description
This study examined the effectiveness of an aquatic OT program for children with sensory processing difficulties to develop water readiness skills and improve sensory, behavior, and engagement goals. Six groups of children with deficits in various sensory systems participated in an 8-week aquatic group led by an occupational therapist and occupational therapy students. Each week consisted of a 45-minute aquatic group with a 5 min warmup on land, 30 mins of aquatic activities addressing the sensory system of the week, and 10 mins addressing a social activity with peers. Goals were developed and assessed via the Goal Attainment Scale (GAS). Parents of the participants were given the Sensory Processing Measure (SPM-2) before beginning. As a result of participating in the aquatic OT intervention, percentage of goals achieved will be analyzed. It is expected that this program proves to be beneficial and therefore aquatic OT shows potential for improving sensory processing skills, behavior, and social participation with peers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every participant receives the intervention. Each child participates in the 8-week aquatic group.
| Arm | Type | Receives |
|---|---|---|
| Aquatic occupational therapy | Experimental | Other: aquatic occupational therapyEach child participated and experienced occupational therapy in the water. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants must be ages 4-9 years old
- have an identified sensory processing problem as related on the SPM assessment
- able to maintain head, neck, and trunk control
- able to follow 1-2 step directions
Key exclusion criteria (3 listed)
- Participants younger than 4 years old and older than 9 years old
- requires lift to get in the water
- difficulty with following 1-step directions
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 therapyAlso: occupational therapy, aquatic therapy, social participationEach week, the children participated in a 45-minute aquatic occupational therapy group that consisted of warmup on land, 30 mins of sensory activities in the water, and 10 mins of social activity in the water | Other | Aquatic occupational therapy |
Primary outcome
Goal Attainment Scaling (GAS)
Time frame: Scores were tracked weekly for 8 weeks of each program.
Goals were written on behavior, engagement/participation, and sensory on a scale from -2 (worse outcome) to +2 (better outcome). Each week scores on each goal were documented.
Parent Surveys
Time frame: Parents were given a post-survey at the 8th week.
Survey with quantitative and qualitative questions about their child's experience and differences seen in the aquatic group
1 secondary outcome
Sensory Processing Measure (SPM: Preschool version: SPM-P, newer edition: SPM-2) Assessment Scores
Time frame: Parents completed SPM on their child before the 8-week group began.
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 3 Jul 2024.
- Individual participant dataSharing planned: Undecided. Not sure if other researchers will want access to this data.
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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.
Kristen M Pataki, OTD principal investigator
Cleveland 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 Sensory Processing Disorder and Autism Spectrum Disorder, run by Kristen Pataki 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 4 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 3 Jul 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?
Goal Attainment Scaling (GAS) (time frame: Scores were tracked weekly for 8 weeks of each program.). The study lists 2 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 3 Jul 2024.