NCT06216613

Brief Summary

The goal of this clinical trial is to compare the effects of a specialized swimming and water-safety program (Sensory Enhanced Aquatics) and standard swimming lessons for autistic children. The main question\[s\]it aims to answer are:

  • Do Sensory Enhanced Aquatics and standard swimming lessons improve swimming and water-safety skills of autistic children?
  • Which participant characteristics are associated with the highest post-intervention swim skills and water safety across both groups? Participants will:
  • Complete questionnaires, motor, and swim tests before the intervention.
  • participate in 16, 30-minute Sensory Enhanced Aquatics lessons.
  • Complete a swim test after the intervention.
  • Complete an interview. Researchers will compare with participation in standard swim lessons to see if which bests teaches swimming and water-safety to autistic children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 14, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

January 11, 2024

Last Update Submit

September 23, 2025

Conditions

Keywords

AutismWater SafetySwimming

Outcome Measures

Primary Outcomes (1)

  • Child Swim Test

    Individual performance test of 5 American Red Cross water competency skills, 5 preparatory swim skills and 2 water-safety skills scored on a 4-point scale with total scored ranging from 0-38.

    pre and post 8 weeks

Study Arms (2)

Sensory Enhanced Aquatics

EXPERIMENTAL

Sensory Enhanced Aquatics is a specialized swimming and water safety program for autistic children.

Behavioral: Sensory Enhanced Aquatics

Standard Swim Lessons

ACTIVE COMPARATOR

Standard swim lessons which are provided to the general public will be used as the comparison group.

Behavioral: Standard Swim Lessons

Interventions

Sensory Enhanced Aquatics (SEA) utilizes the Sensory Profile to individualize lessons based on children's sensory preferences. The program incorporates evidence-based approaches for autistic children, including: 1) visual supports, 2) sensory supports, 3) communication strategies, 4) behavioral strategies, and 5) modeling to maximize skill acquisition. Lessons will be 1:1 with social opportunities at the beginning and end of each lesson. Like standard swim lessons, skills are taught in progression from water orientation (e.g., blowing bubbles, submerging different body parts) to advanced swimming (e.g., swimming 15 or more yards of different swim strokes). All lessons include instruction of water safety skills. Each skill has been task analyzed by therapists so instruction can be graded according to children's ability. A social story is provided to transition children to lessons. SEA curriculum was reviewed by USA Swimming Foundation and is included as a Swim Lesson Network Provider.

Sensory Enhanced Aquatics

Standard swim lessons will adhere to USA Swimming Foundation Swim Network Provider requirements ensuring lessons meet or exceed industry best practices. Lessons have up to a 1:5 instructor to child ratio and will focus on stroke development and water-safety with skills advancing from water-orientation to stroke technique and endurance.

Standard Swim Lessons

Eligibility Criteria

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

You may qualify if:

  • Age 5-9 yrs. who have received a clinical diagnosis for autism based on Diagnostic and statistical manual of mental disorders: DSM-5 criteria
  • A Social Responsiveness Scale-2 (SRS-2) T-score of ≥ 60
  • Sufficient functional ability to understand directions and communicate preferences (verbally or non-verbally)
  • Baseline swim test score ≤22
  • No plans to relocate outside the study area during the intervention period.
  • Physician consent.

You may not qualify if:

  • Uncontrolled epilepsy, as seizures increase risk of drowning.
  • Baseline swim test score ≥23
  • Aggressive behaviors that would put instructor safety at risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The nature of our intervention precludes blinding of the interventionists and participants; however, investigators not involved in the intervention, data analysts and research assistants will be blinded to condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with 50 participants who will be randomized 1:1 to either the Sensory Enhanced Aquatics intervention or control condition with standard swim lessons.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 22, 2024

Study Start

April 14, 2024

Primary Completion

July 30, 2025

Study Completion

September 4, 2025

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The raw data will be preserved at the local site per local institutional policies and guidelines. However, the data that will be preserved and made available for sharing will be the summary or scored data for each participant at each data collection timepoint. We have made this decision to provide summary or scored data to allow for the data that are available to be consistent across the various uses (e.g., to minimize the likelihood of scoring errors by others who may use the data). However, if the study sponsor or other regulatory entity requests that we reconsider this decision, we are willing to consider this request. We will also share audio recordings of interviews.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
The data will be made available no later than the time of an associated publication or at the end of the performance period, whichever comes first. We will also work closely with our Data and Safety Monitoring Board to identify any applicable embargo periods that may be necessary to maintain the integrity of the study and will implement these in an appropriate manner that is consistent with NIH and local institutional policies. The data provided to the repository will be available indefinitely while that repository continues to exist.
Access Criteria
we will upload our data to the National Database for Autism Research (NDAR)
More information

Locations