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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

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

  • 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

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
Intervention / Treatment
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

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

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

University of Miami

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • 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)

August 2, 2022

Primary Completion (Actual)

June 10, 2023

Study Completion (Actual)

June 10, 2023

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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