Water Competency Intervention in Autism

NCT07076264 | Recruiting

• 2 other identifiers: STUDY20250101E06288.1a
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist. Overall, this study has 3 major aims. The first aim evaluates the effectiveness of the AquOTic intervention in improving water competency and swim skills, while comparing outcomes between two implementation models: professional student interventionists (occupational and physical therapy students) and trained community-based interventionists. A total of 108 autistic children will be enrolled and randomly assigned to one of three groups: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention. The second aim explores the mediators and moderators of the intervention outcomes to assess fidelity and efficacy. The third aim identifies the cost and resources associated with AquOTic. A cost analysis will be conducted to evaluate the resources required for implementation and to inform the development of a scalable, cost-effective drowning prevention strategy for autistic populations.

Conditions

Autism Spectrum Disorders

Keywords

Swim Safety; Water Competency; Occupational Therapy; AquOTic; Drowning Prevention

Outcome Measures

Primary Outcomes (1)

• Water Orientation Test-Alyn (WOTA) 2

  The WOTA2 measures a child's mental adaptation, adjustment to the pool, postural balance, and the ability to move and change position in the water, based on the Halliwick concept. WOTA2 assesses 27 swim skills scored on a 0-3 scale with a minimal detectable change score of 11.5. Higher scores indicate better skills. WOTA2 has high test-retest reliability (ICC=.97) and is validated for children with autism-like characteristics.

  At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic

Secondary Outcomes (3)

• Water Orientation Test-Alyn (WOTA) 1

  At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic

• Water Competency Checklist (WCC)

  At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic

• Canadian Occupational Performance Measure (COPM)

  At baseline, immediately post-AquOTic, 6 months after termination of AquOTic, and 12 months after termination of AquOTic

Study Arms (3)

AquOTic with Professional Student Interventionist

EXPERIMENTAL

Participants in this arm will participate in the 10-week AquOTic intervention with their one to one interventionists being professional students (OT/PT students currently enrolled at OSU).

Other: AquOTic

AquOTic with Community Interventionists

EXPERIMENTAL

Participants in this arm will participate in the 10-week AquOTic intervention with their one to one interventionists being community interventionists (high school or undergraduate students in the community).

Other: AquOTic

Control Group

NO INTERVENTION

Participants will NOT receive AquOTic intervention and will engage in usual and customary water exposure.

Interventions

AquOTic OTHER

AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist.

AquOTic with Community Interventionists; AquOTic with Professional Student Interventionist

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Educational or medical diagnosis of autism
• Age between 5 - 9 years
• Having vision and hearing within normal limits with or without corrective modifications

You may not qualify if:

• Children who demonstrate swim proficiency, as defined by the ability to tread water for 1 minute or move the body through the water without flotation
• Open wounds or infectious skin diseases
• Allergy to chlorine
• Severe co-occurring motor impairments or neurological conditions such as uncontrolled seizures, Rett's or Angelman's syndrome
• The family is unable to commit to the sessions or evaluations
• Interventionists (n=64)
• Aged 18 or over
• Demonstrate swim proficiency, as defined by the ability to tread water for 1 minute and move the body through the water without flotation for 25 yards
• Open wounds or infectious diseases
• Failed background check
• Unable to commit to Basic Swim Instructor and AquOTic training (\~40 hours) and 10 AquOTic sessions (20 hours)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

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.

  PMID: 39435387 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Jewel Crasta, PhD

CONTACT

(970) 682 - 8031; jewel.crasta@osumc.edu

Erika Kemp, OTD

CONTACT

(608) 335 - 9230; erika.kemp@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study employs a hybrid Type I efficacy-implementation design, aiming to evaluate both the effectiveness of the AquOTic intervention and to advance the science of implementation. While hybrid Type I trials traditionally emphasize clinical effectiveness, this study extends beyond identifying implementation barriers and facilitators by preliminarily assessing proposed implementation mechanisms. Specifically, it will examine therapeutic alliance and attitudes toward the AquOTic intervention as hypothesized factors associated with high intervention fidelity. The trial will utilize a single-blinded, randomized controlled trial (RCT) design, with participants randomly assigned to one of three study arms: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention, while outcomes assessors will remain blinded to group assignment.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified data will be made available after the completion of the study.

Locations

US (1)