Skip to main content
OpenTrials
Completed

NCT Number: NCT06938230

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Number of Children Who Received COVID-19 Vaccine

    Time frame: Baseline

    unit of measure number of children

  5. 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.

  6. 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

  7. 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.

  8. Number of Children Who Received COVID-19 Vaccine

    Time frame: 6 months

    unit of measure number of children

Secondary outcomes

  1. 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".

  2. 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".

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.