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

NCT06938230 | Completed Results

• 2 other identifiers: 202202541OT2HD108111-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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

  Baseline

• Number of Children Who Received COVID-19 Vaccine

  unit of measure number of children

  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.

  Baseline

• Number of Caregivers Who Received COVID-19 Vaccine

  The unit of measure is the number of caregivers who received COVID-19 vaccine

  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.

  6 month

• Number of Children Who Received COVID-19 Vaccine

  unit of measure number of children

  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)

  Baseline, 6 month follow up

• COVID Anxiety as Measured by the Coronavirus Anxiety Scale

  Baseline, 6 month follow up

Study Arms (2)

Health Education Initiative

EXPERIMENTAL

Participants will receive the health education session for up to 6 months.

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.

Interventions

Health Education Initiative BEHAVIORAL

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.

Health Education Initiative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Does not speak:
• English
• Spanish
• Creole

Sponsors & Collaborators

• University of Miami: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Lisa Gwynn
• Organization: University of Miami

LGwynn@med.miami.edu

305-243-3440

Study Officials

• Lisa Gwynn, DO

  University of Miami

  PRINCIPAL INVESTIGATOR

• Elizabeth Pulgaron, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 22, 2025
• Study Start: August 2, 2022
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)