- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05977530
Teaching Young Children Swim Survival Skills
January 22, 2024 updated by: David Schwebel, University of Alabama at Birmingham
This study is designed to evaluate whether commercially-available swim self-rescue schools are effective to teach children ages 12-23 months to stay safely alive floating in the water (or grasping the pool's edge) without adult intervention.
The investigators will measure children's water self-rescue skills at baseline and then they will engage in commercially-available training over the course of several weeks.
The investigators will then measure their skills again.
Assessments will be conducted using a standardized protocol with a certified lifeguard present.
Parents will also complete a short survey concerning child and family demographics and child and family swim and lifeguard training experience.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- UAB Youth Safety Lab, University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- child ages 12-23 months
- enrolled in self-rescue course at participating swim facility
Exclusion Criteria:
- medical conditions counter-indicating training in water
- previous experience in self-rescue swim courses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: self-rescue training
children will receive self-rescue training from a certified instructor
|
children will receive training for self-rescue if they are alone in water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
experimenter-designed standardized behavioral assessment of children's self-rescue ability
Time Frame: at completion of training intervention program, an anticipated average of 4 weeks
|
assessment of whether children can float alone or reach the pool's edge, without adult assistance
|
at completion of training intervention program, an anticipated average of 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
July 18, 2023
First Submitted That Met QC Criteria
July 26, 2023
First Posted (Actual)
August 4, 2023
Study Record Updates
Last Update Posted (Estimated)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300011508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will share de-identified data with qualified researchers upon request.
IPD Sharing Time Frame
Data will become available after all primary results are published.
They will remain available for at least 3 years.
IPD Sharing Access Criteria
Contact Study PI David Schwebel.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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