NCT05524753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

August 30, 2022

Last Update Submit

October 23, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

AquOTic

EXPERIMENTAL

Dose of 10 weeks of aquatic occupational therapy

Behavioral: AquOTic

Control

NO INTERVENTION

No intervention

Interventions

AquOTicBEHAVIORAL

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

AquOTic

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors are blinded to whether or not the client received the intervention or control/waitlist.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a waitlist control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Clinical

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 1, 2022

Study Start

August 4, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

De-identified data regarding swim skill changes may be shared with other researchers

Locations