Aquatic Therapy for ASD
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquatic Occupational Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
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
Sites / Locations
- The Ohio State UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aquatic Occupational Therapy
Arm Description
Group-based aquatic occupational therapy with 1:1 swim buddy for safety.
Outcomes
Primary Outcome Measures
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
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.
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.
Parent perspective
qualitative interview regarding parent perspective of the the intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT05092321
First Posted
September 16, 2021
Last Updated
October 23, 2023
Sponsor
Ohio State University
Collaborators
Franklin County Board of Developmental Disabilities
1. Study Identification
Unique Protocol Identification Number
NCT05092321
Brief Title
Aquatic Therapy for ASD
Official Title
Exploration of Aquatic Therapy in Children With Autism and Their Families
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Franklin County Board of Developmental Disabilities
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aquatic Occupational Therapy
Arm Type
Experimental
Arm Description
Group-based aquatic occupational therapy with 1:1 swim buddy for safety.
Intervention Type
Behavioral
Intervention Name(s)
Aquatic Occupational Therapy
Intervention Description
Group of 4-8 children, paired with a swim buddy. Intervention techniques including discrete teaching, motor shaping, behavioral management, therapeutic relationship and individualized goals.
Primary Outcome Measure Information:
Title
Change in swim skills
Description
Change in swim skills measured with Water Orientation Test-Alyn; higher scores mean a better outcome. Minimum score is 0, maximum is 27
Time Frame
baseline, pre-intervention; immediately after the intervention
Title
Change in individualized goals
Description
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.
Time Frame
immediately after the intervention
Title
Change in parent comfort
Description
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.
Time Frame
baseline pre-intervention; immediately after the intervention
Title
Parent perspective
Description
qualitative interview regarding parent perspective of the the intervention
Time Frame
one time after 8 hours of intervention have been provided to the child participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Kemp
Phone
614-292-8167
Email
erika.kemp@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Kemp
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Kemp
Email
erika.kemp@osumc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data may be shared with other researchers.
Learn more about this trial
Aquatic Therapy for ASD
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