Active Ingredients & Efficacy of Aquatic Therapy for Autistic Children

Active Ingredients & Efficacy of AquOTic: Aquatic Occupational Therapy for Children on the Autism Spectrum

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: AquOTic

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: AquOTic; Dose of 10 weeks of aquatic occupational therapy	Behavioral: AquOTic; group-based aquatic occupational therapy sessions with 1:1 support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, pre-intervention; immediately after the intervention
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.	pre intervention, immediately after the intervention
Parent Perspective	qualitative interview regarding parent perspective of the intervention	one time after at least 8 hours of the intervention has been provided to the child

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: American Occupational Therapy Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 2019H0204 Phase 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data regarding swim skill changes 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