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Active Ingredients & Efficacy of Aquatic Therapy for Autistic Children

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AquOTic
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • pre-existing diagnosis of autism & interest in learning to swim

Exclusion Criteria:

  • able to float or move through the water for 5-10 feet without assistance.
  • presence of compromised airway such as trachea or ventilation system
  • other contraindication to submersion in water.

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AquOTic

Control

Arm Description

Dose of 10 weeks of aquatic occupational therapy

No intervention

Outcomes

Primary Outcome Measures

Change in swim skills
change in swim skills using Water Orientation Test-Alyn. A higher score means a better outcome. Minimum score 0, maximum score 71.
Questionnaire to track change in parent perception and satisfaction with progress on individualized family-centered goals
Canadian Occupational Performance Measure to establish goals with parents and track performance and satisfaction with goals. A higher score indicates higher parent satisfaction and child performance on the goals.
Parent Perspective
qualitative interview regarding parent perspective of the intervention

Secondary Outcome Measures

Full Information

First Posted
August 30, 2022
Last Updated
October 23, 2023
Sponsor
Ohio State University
Collaborators
American Occupational Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05524753
Brief Title
Active Ingredients & Efficacy of Aquatic Therapy for Autistic Children
Official Title
Active Ingredients & Efficacy of AquOTic: Aquatic Occupational Therapy for Children on the Autism Spectrum
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
American Occupational Therapy Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Accidental drowning is the number one cause of death in children with autism spectrum disorders (ASD) and highlights the critical need for swim lessons and water safety training for this population. Our team has developed and tested an innovative, occupational therapy (OT) based aquatic program - AquOTic - that provides preliminary support for the use of an individualized swim skills training intervention in children with ASD. The AquOTic program uses a combination of sensory, motor learning, and behavioral approaches to improve water safety and swim skills. In this study, we will use a randomized control trial design to identify the efficacy of the AquOTic intervention to improve swim performance in children with ASD.
Detailed Description
Once enrolled, children will be randomized to one of three groups. Group A will receive the intervention right away. Group B will use a waitlist control for 10 weeks, then will receive the intervention. Group C will be a control group, and will be offered the intervention at the end of the control period. Each group will have 12 participants. AquOTic a group based aquatic occupational therapy intervention that uses evidence-based therapeutic teaching techniques including therapeutic relationship, grading of activities, shaping, positive reinforcement and individualized goals to direct the intervention. We will also develop a fidelity measure to operationalize the therapeutic strategies and quantify the active ingredients of the AquOTic program. Our long-term goal is to create evidence for an OT-based swim intervention for children with ASD that has the potential to decrease the drowning risk in this population.

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
Parallel Assignment
Model Description
This study uses a waitlist control group.
Masking
Outcomes Assessor
Masking Description
Outcome assessors are blinded to whether or not the client received the intervention or control/waitlist.
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AquOTic
Arm Type
Experimental
Arm Description
Dose of 10 weeks of aquatic occupational therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
AquOTic
Intervention Description
group-based aquatic occupational therapy sessions with 1:1 support
Primary Outcome Measure Information:
Title
Change in swim skills
Description
change in swim skills using Water Orientation Test-Alyn. A higher score means a better outcome. Minimum score 0, maximum score 71.
Time Frame
baseline, pre-intervention; immediately after the intervention
Title
Questionnaire to track change in parent perception and satisfaction with progress on individualized family-centered goals
Description
Canadian Occupational Performance Measure to establish goals with parents and track performance and satisfaction with goals. A higher score indicates higher parent satisfaction and child performance on the goals.
Time Frame
pre intervention, immediately after the intervention
Title
Parent Perspective
Description
qualitative interview regarding parent perspective of the intervention
Time Frame
one time after at least 8 hours of the intervention has been provided to the child

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pre-existing diagnosis of autism & interest in learning to swim Exclusion Criteria: able to float or move through the water for 5-10 feet without assistance. presence of compromised airway such as trachea or ventilation system other contraindication to submersion in water.
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data regarding swim skill changes may be shared with other researchers

Learn more about this trial

Active Ingredients & Efficacy of Aquatic Therapy for Autistic Children

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