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

December 31, 2025 updated by: Lisa Gwynn, University of Miami

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion criteria:

  • Does not speak:
  • English
  • Spanish
  • Creole

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health Education Initiative
Participants will receive the health education session for up to 6 months.
Behavioral: Health Education Initiative
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.
No Intervention: Control Group
Participants in this group will not receive any health education and total participation is up to 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
6 months
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
Baseline
Number of Children Who Received COVID-19 Vaccine
Time Frame: Baseline
unit of measure number of children
Baseline
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.
Baseline
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
6 months
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.
6 month
Number of Children Who Received COVID-19 Vaccine
Time Frame: 6 months
unit of measure number of children
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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".
Baseline, 6 month follow up
COVID Anxiety as Measured by the Coronavirus Anxiety Scale
Time Frame: Baseline, 6 month follow up
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".
Baseline, 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Gwynn, DO, University of Miami
  • Principal Investigator: Elizabeth Pulgaron, PhD, University of Miami

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20220254
  • 1OT2HD108111-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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