Active Ingredients & Efficacy of Aquatic Therapy for Autistic Children

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05524753
• Other study ID #: 2019H0204 Phase 2
• Status: Completed
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• AquOTic
group-based aquatic occupational therapy sessions with 1:1 support

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	American Occupational Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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