Active Ingredients & Efficacy of Aquatic Therapy for Autistic Children

NCT ID: NCT05524753

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-04

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a waitlist control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors are blinded to whether or not the client received the intervention or control/waitlist.

Study Groups

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AquOTic

Dose of 10 weeks of aquatic occupational therapy

Group Type EXPERIMENTAL

AquOTic

Intervention Type BEHAVIORAL

group-based aquatic occupational therapy sessions with 1:1 support

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AquOTic

group-based aquatic occupational therapy sessions with 1:1 support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Occupational Therapy Foundation

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Erika Kemp

Assistant Professor, Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Kemp E, Nikahd M, Howard M, Darragh A, Crasta JE. Improving water competency among children on the autism spectrum: the AquOTic randomized controlled trial. Front Pediatr. 2024 Oct 7;12:1473328. doi: 10.3389/fped.2024.1473328. eCollection 2024.

Reference Type DERIVED
PMID: 39435387 (View on PubMed)

Other Identifiers

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2019H0204 Phase 2

Identifier Type: -

Identifier Source: org_study_id

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