DrowningNCT05977530
Teaching Young Children Swim Survival Skills
A study testing self-rescue training in people with Drowning, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Drowning
- What is being tested?
- self-rescue training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 23 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child ages 12-23 months
- enrolled in self-rescue course at participating swim facility
Who cannot join
- medical conditions counter-indicating training in water
- previous experience in self-rescue swim courses
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Youth Safety Lab, University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Drowning
- Being tested
- self-rescue training
- Medical subject headings
- Drowning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-rescue trainingBehavioural
children will receive training for self-rescue if they are alone in water
| Study group | Role | What they receive |
|---|---|---|
| self-rescue training | Experimental | children will receive self-rescue training from a certified instructor Receives: Behavioral: self-rescue training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Self-rescue Ability
Assessment of whether children demonstrates ability to engage independently and safely in water, without adult assistance. This was measured through a standardized behavioral observation of children's behavior in a swimming pool. It was scored in a binary fashion as "yes" or "no", with each child in the study scored either "yes" or "no".
Measured: at completion of training intervention program, an anticipated average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start16 Sep 2024
- Primary completion1 Nov 2024
- Study completion23 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DrowningStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Schwebel, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977530
- Sponsor's protocol ID
- IRB-300011508
- Status last verified
- Feb 2025
- First submitted
- 18 Jul 2023
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified data with qualified researchers upon request.
Publications
Schwebel DC, Johnston A. Toddler drowning prevention through self-rescue: can 1-year-old children learn to float? Inj Prev. 2025 Nov 11:ip-2025-045688. doi: 10.1136/ip-2025-045688. Online ahead of print.
PubMed 41219144
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Young Children Swim Survival Skills
- ClinicalTrials.gov ID
- NCT05977530
- Acronym / sponsor ID
- IRB-300011508
- Conditions
- Drowning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| self-rescue training | Experimental | Behavioral: self-rescue trainingchildren will receive self-rescue training from a certified instructor |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child ages 12-23 months
- enrolled in self-rescue course at participating swim facility
Key exclusion criteria (2 listed)
- medical conditions counter-indicating training in water
- previous experience in self-rescue swim courses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-rescue trainingchildren will receive training for self-rescue if they are alone in water | Behavioural | self-rescue training |
Primary outcome
Children's Self-rescue Ability
Time frame: at completion of training intervention program, an anticipated average of 4 weeks
Assessment of whether children demonstrates ability to engage independently and safely in water, without adult assistance. This was measured through a standardized behavioral observation of children's behavior in a swimming pool. It was scored in a binary fashion as "yes" or "no", with each child in the study scored either "yes" or "no".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41219144Schwebel DC, Johnston A. Toddler drowning prevention through self-rescue: can 1-year-old children learn to float? Inj Prev. 2025 Nov 11:ip-2025-045688. doi: 10.1136/ip-2025-045688. Online ahead of print.
- Individual participant dataSharing planned: Yes. We will share de-identified data with qualified researchers upon request.
Related trials for Drowning
Recruiting
Water Competency Intervention in Autism
Autism Spectrum Disorders
Recruiting
Drowning-related Acute Respiratory Failure
Drowning
Active, not recruitingObservational study
Primary or Secondary Drowning
Drowning, Drowning; Anoxia
Active, not recruitingObservational study
Using Machine Learning to Optimise the Danish Drowning Formula
Drowning, Drowning and Submersion While in Bath-Tub
RecruitingObservational study
The Emergency Call on Drowning
Drowning, Drowning; Anoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-rescue training in people with Drowning, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Self-rescue Ability (time frame: at completion of training intervention program, an anticipated average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05977530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.