- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05092321
Aquatic Therapy for ASD
April 29, 2024 updated by: Erika Kemp, Ohio State University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erika Kemp
- Phone Number: 614-292-8167
- Email: erika.kemp@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- pre-existing diagnosis of autism spectrum disorder from a medical professional
- family interest in swimming
Exclusion Criteria:
- ventilation system for breathing such as trachea not capped
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aquatic Occupational Therapy
Group-based aquatic occupational therapy with 1:1 swim buddy for safety.
|
Group of 4-8 children, paired with a swim buddy.
Intervention techniques including discrete teaching, motor shaping, behavioral management, therapeutic relationship and individualized goals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, pre-intervention; immediately after the intervention
|
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.
|
immediately after the intervention
|
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.
|
baseline pre-intervention; immediately after the intervention
|
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
|
one time after 8 hours of intervention have been provided to the child participant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Erika Kemp, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2021
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 16, 2021
First Submitted That Met QC Criteria
October 12, 2021
First Posted (Actual)
October 25, 2021
Study Record Updates
Last Update Posted (Estimated)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 29, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019J0204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
De-identified data may be shared with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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