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

Not Applicable

Completed

• Conditions: COVID-19

• Registration Number: NCT06938230
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-02
• Primary Completion: 2023-06-10
• Study Completion: 2023-06-10
• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Study First Posted: 2025-04-22
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of acceptability of intervention as measured by Acceptability Questionnaire	up to 6 months	Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction.
Evaluation of confidence in COVID healthcare decision making as measured by COVID Confidence Questionnaire	up to 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	up to 6 months	unit of measure number of caregivers
Number of children who received COVID-19 vaccine	up to 6 months	unit of measure number of children
Health behaviors as measured by Health Behavior Questionnaire	up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
PTSD as measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD)	up to 6 months	scores range from 0 to 4, higher scores indicate more symptoms of PTSD
COVID anxiety as measured by the Coronavirus Anxiety Scale	up to 6 months	scores range from 0 to 4, higher scores indicate more symptoms of COVID specific anxiety

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States