NCT05092321

Brief Summary

This is an aquatic occupational therapy group for children between the ages of 3-12 that have an autism diagnosis. Intervention will focus on increasing the child's safety swim skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 14, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

September 16, 2021

Last Update Submit

December 11, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in swim skills

    Change in swim skills measured with Water Orientation Test-Alyn; higher scores mean a better outcome. Minimum score is 0, maximum is 27

    baseline, pre-intervention; immediately after the intervention

  • Change in individualized goals

    Goal Attainment Scaling to track change in other swim performance skills not measured above. Scores for each goal range from -2 (regression) to +2 (2 levels more than anticipated). A higher score indicates improvement.

    immediately after the intervention

  • Change in parent comfort

    Custom questionnaire using 5 point Likert scale regarding comfort and importance of water participation for the child. A higher score indicates increased parent comfort, which is the desirable direction.

    baseline pre-intervention; immediately after the intervention

  • Parent perspective

    qualitative interview regarding parent perspective of the the intervention

    one time after 8 hours of intervention have been provided to the child participant

Study Arms (1)

Aquatic Occupational Therapy

EXPERIMENTAL

Group-based aquatic occupational therapy with 1:1 swim buddy for safety.

Behavioral: Aquatic Occupational Therapy

Interventions

Group of 4-8 children, paired with a swim buddy. Intervention techniques including discrete teaching, motor shaping, behavioral management, therapeutic relationship and individualized goals.

Aquatic Occupational Therapy

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • pre-existing diagnosis of autism spectrum disorder from a medical professional
  • family interest in swimming

You may not qualify if:

  • ventilation system for breathing such as trachea not capped

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Erika Kemp

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Clinical

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 25, 2021

Study Start

September 14, 2021

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

De-identified data may be shared with other researchers.

Locations