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

NCT ID: NCT06938230

Last Updated: 2026-01-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2023-06-10

Brief Summary

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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

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Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Health Education Initiative

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

Group Type EXPERIMENTAL

Health Education Initiative

Intervention Type 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.

Control Group

Participants in this group will not receive any health education and total participation is up to 6 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Lisa Gwynn

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Gwynn, DO

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Elizabeth Pulgaron, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1OT2HD108111-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20220254

Identifier Type: -

Identifier Source: org_study_id

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