COVID-19NCT06938230

Coronavirus Disease of 2019 (COVID-19) Health Education Initiative for School Safety

A study testing Health Education Initiative in people with COVID-19, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare COVID-19 knowledge, experiences, and health behaviors between participants who received the health initiative and those who did not. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Health Education Initiative
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteUnited States
Study dates: 2 Aug 2022to 10 Jun 2023
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Parents/guardians of students enrolled in:
Arch Creek Elementary, Fulford Elementary
Greynolds Park Elementary
Sabal Palm Elementary
North Miami Middle school,
John F Kennedy (JFK) Middle School

Show all 10Show fewer

North Miami Senior High
North Miami Beach High
Booker T. Washington High
Able to read and write in English, Spanish, or Creole at a 5th grade level

Who cannot join

Does not speak:
English
Spanish
Creole

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Promoting A School Culture of Safety in the Era of COVID-19: Assessing Feasibility and Impact of a Health Education Initiative

The purpose of this study is to compare COVID-19 knowledge, experiences, and health behaviors between participants who received the health initiative and those who did not.

Conditions: COVID-19
Being tested: Health Education Initiative
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health Education InitiativeBehavioural
Participants will receive a one time 45 minute intervention session. During the session participants will receive information regarding COVID-19 disease process and behavioral effects and had the opportunity to ask questions.

Study groups in NCT06938230
Study group	Role	What they receive
Health Education Initiative	Experimental	Participants will receive the health education session for up to 6 months. Receives: Behavioral: Health Education Initiative
Control Group	No intervention	Participants in this group will not receive any health education and total participation is up to 6 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction. Evaluation was collected directly after the intervention, at baseline.
Measured: Baseline
Evaluation of Confidence in COVID Healthcare Decision Making as Measured by COVID Confidence Questionnaire
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction.
Measured: 6 months
Number of Caregivers Who Received COVID-19 Vaccine
The unit of measure is the number of caregivers who received COVID-19 vaccine at baseline
Measured: Baseline
Number of Children Who Received COVID-19 Vaccine
unit of measure number of children
Measured: Baseline
Health Behaviors as Measured by Health Behavior Questionnaire
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating greater intent to engage in health behaviors to prevent COVID-19.
Measured: Baseline
Number of Caregivers Who Received COVID-19 Vaccine
The unit of measure is the number of caregivers who received COVID-19 vaccine
Measured: 6 months
Health Behaviors as Measured by Health Behavior Questionnaire
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating greater intent to engage in health behaviors to prevent COVID-19.
Measured: 6 month
Number of Children Who Received COVID-19 Vaccine
unit of measure number of children
Measured: 6 months

Secondary outcomes (2)

PTSD as Measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD)
Individual item scores range from 0 to 4, individual total sum scores range from 0 to 44 higher scores indicate more symptoms of PTSD. Total sum score ranging from 1-10 is considered "minimal PTSD", total sum score ranging from 11-20 is considered "mild PTSD", total sum scores of 21 or more is considered "potential PTSD".
Measured: Baseline, 6 month follow up
COVID Anxiety as Measured by the Coronavirus Anxiety Scale
individual item score ranges from 0 to 4, individual total sum scores range from 0 to 20 higher scores indicate more symptoms of COVID specific anxiety. Total sum scores of greater than of equal to 9 equals "probable dysfunctional Coronavirus related anxiety".
Measured: Baseline, 6 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 202210 Jun 2023

First posted22 Apr 2025
Study start2 Aug 2022
Primary completion10 Jun 2023
Study completion10 Jun 2023

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.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by University of MiamiThe 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: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06938230
Sponsor's protocol ID: 20220254
Other IDs: 1OT2HD108111-01
Status last verified: Dec 2025
First submitted: 17 Apr 2025
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promoting A School Culture of Safety in the Era of COVID-19: Assessing Feasibility and Impact of a Health Education Initiative
ClinicalTrials.gov ID: NCT06938230
Acronym / sponsor ID: 20220254
Conditions: COVID-19
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 2 Aug 2022 (actual)
Primary completion: 10 Jun 2023 (actual)
Study completion: 10 Jun 2023 (actual)
First posted: 22 Apr 2025 (actual)
Results: Posted 6 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare COVID-19 knowledge, experiences, and health behaviors between participants who received the health initiative and those who did not.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Health Education Initiative	Experimental	Behavioral: Health Education InitiativeParticipants will receive the health education session for up to 6 months.
Control Group	No intervention	–Participants in this group will not receive any health education and total participation is up to 6 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Parents/guardians of students enrolled in:
Arch Creek Elementary, Fulford Elementary
Greynolds Park Elementary
Sabal Palm Elementary
North Miami Middle school,

Key exclusion criteria (4 listed)

Does not speak:
English
Spanish
Creole

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
Health Education InitiativeParticipants will receive a one time 45 minute intervention session. During the session participants will receive information regarding COVID-19 disease process and behavioral effects and had the opportunity to ask questions.	Behavioural	Health Education Initiative

Primary outcome

Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire
Time frame: Baseline
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction. Evaluation was collected directly after the intervention, at baseline.
Evaluation of Confidence in COVID Healthcare Decision Making as Measured by COVID Confidence Questionnaire
Time frame: 6 months
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction.
Number of Caregivers Who Received COVID-19 Vaccine
Time frame: Baseline
The unit of measure is the number of caregivers who received COVID-19 vaccine at baseline
Number of Children Who Received COVID-19 Vaccine
Time frame: Baseline
unit of measure number of children
Health Behaviors as Measured by Health Behavior Questionnaire
Time frame: Baseline
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating greater intent to engage in health behaviors to prevent COVID-19.
Number of Caregivers Who Received COVID-19 Vaccine
Time frame: 6 months
The unit of measure is the number of caregivers who received COVID-19 vaccine
Health Behaviors as Measured by Health Behavior Questionnaire
Time frame: 6 month
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating greater intent to engage in health behaviors to prevent COVID-19.
Number of Children Who Received COVID-19 Vaccine
Time frame: 6 months
unit of measure number of children

2 secondary outcomes

PTSD as Measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD)
Time frame: Baseline, 6 month follow up
COVID Anxiety as Measured by the Coronavirus Anxiety Scale
Time frame: Baseline, 6 month follow up

Results and safety

Results posted to the registry on 6 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Health Education Initiative	76	20
Control Group	36	18

Primary outcome: Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Health Education Initiative n = 76
Value	4.47 (0.89)

Population analysed: This was data collection only for the health education initiative. The control group did not participate in this section.

Primary outcome: Evaluation of Confidence in COVID Healthcare Decision Making as Measured by COVID Confidence Questionnaire

Time frame: 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Health Education Initiative n = 76
Value	4.38 (0.86)

Population analysed: This was only administered to the intervention group. No control participants were analyzed because they did not receive this measure.

Primary outcome: Number of Caregivers Who Received COVID-19 Vaccine

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Health Education Initiative n = 49	Control Group n = 34
Value	35	24

Population analysed: The number of participants analyzed at 6 months is lower than those who were analyzed at baseline due to participants lost to follow-up.

Primary outcome: Number of Children Who Received COVID-19 Vaccine

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Health Education Initiative n = 52	Control Group n = 35
Value	23	18

Population analysed: The number of participants analyzed at baseline differs from the number analyzed at 6 months because participants were lost to follow-up.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Health Education Initiative	0 of 76 (0%)	0 of 76 (0%)	0 of 76
Control Group	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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.

Lisa Gwynn, DO principal investigator

University of Miami

Elizabeth Pulgaron, PhD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Health Education Initiative in people with COVID-19, run by University of Miami 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 10 inclusion and 4 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 6 Jan 2026. 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 6 Jan 2026). 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?

Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire (time frame: Baseline). The study lists 8 primary outcomes in all. 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 NCT06938230.

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 6 Jan 2026.