Trial Outcomes & Findings for Coronavirus Disease of 2019 (COVID-19) Health Education Initiative for School Safety (NCT NCT06938230)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

Baseline

Results posted on

2026-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Health Education Initiative Participants will receive the health education session for up to 6 months. 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.	Control Group Participants in this group will not receive any health education and total participation is up to 6 months.
Overall Study STARTED	76	36
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	56	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Health Education Initiative Participants will receive the health education session for up to 6 months. 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.	Control Group Participants in this group will not receive any health education and total participation is up to 6 months.
Overall Study Lost to Follow-up	56	18

Baseline Characteristics

There were only 64 participants analyzed because the remaining participants did not respond to the question.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Education Initiative n=76 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=36 Participants Participants in this group will not receive any health education and total participation is up to 6 months.	Total n=112 Participants Total of all reporting groups
Age, Continuous	44.34 years STANDARD_DEVIATION 8.80 • n=29 Participants • There were only 64 participants analyzed because the remaining participants did not respond to the question.	41.69 years STANDARD_DEVIATION 7.85 • n=35 Participants • There were only 64 participants analyzed because the remaining participants did not respond to the question.	42.89 years STANDARD_DEVIATION 8.14 • n=64 Participants • There were only 64 participants analyzed because the remaining participants did not respond to the question.
Sex: Female, Male Female	26 Participants n=29 Participants • There were only 65 participants analyzed, because the remaining participants did not respond to the question.	32 Participants n=36 Participants • There were only 65 participants analyzed, because the remaining participants did not respond to the question.	58 Participants n=65 Participants • There were only 65 participants analyzed, because the remaining participants did not respond to the question.
Sex: Female, Male Male	3 Participants n=29 Participants • There were only 65 participants analyzed, because the remaining participants did not respond to the question.	4 Participants n=36 Participants • There were only 65 participants analyzed, because the remaining participants did not respond to the question.	7 Participants n=65 Participants • There were only 65 participants analyzed, because the remaining participants did not respond to the question.
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=76 Participants	5 Participants n=36 Participants	12 Participants n=112 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=76 Participants	31 Participants n=36 Participants	48 Participants n=112 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	52 Participants n=76 Participants	0 Participants n=36 Participants	52 Participants n=112 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=76 Participants	0 Participants n=36 Participants	0 Participants n=112 Participants
Race (NIH/OMB) Asian	0 Participants n=76 Participants	1 Participants n=36 Participants	1 Participants n=112 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=76 Participants	0 Participants n=36 Participants	0 Participants n=112 Participants
Race (NIH/OMB) Black or African American	18 Participants n=76 Participants	28 Participants n=36 Participants	46 Participants n=112 Participants
Race (NIH/OMB) White	8 Participants n=76 Participants	5 Participants n=36 Participants	13 Participants n=112 Participants
Race (NIH/OMB) More than one race	1 Participants n=76 Participants	0 Participants n=36 Participants	1 Participants n=112 Participants
Race (NIH/OMB) Unknown or Not Reported	49 Participants n=76 Participants	2 Participants n=36 Participants	51 Participants n=112 Participants

PRIMARY outcome

Timeframe: Baseline

Population: This was data collection only for the health education initiative. The control group did not participate in this section.

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.

Outcome measures

Outcome measures
Measure	Health Education Initiative n=76 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group Participants in this group will not receive any health education and total participation is up to 6 months.
Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire	4.47 score on a scale Standard Deviation 0.89	—

PRIMARY outcome

Timeframe: 6 months

Population: This was only administered to the intervention group. No control participants were analyzed because they did not receive this measure.

Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction.

Outcome measures

Outcome measures
Measure	Health Education Initiative n=76 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group Participants in this group will not receive any health education and total participation is up to 6 months.
Evaluation of Confidence in COVID Healthcare Decision Making as Measured by COVID Confidence Questionnaire	4.38 score on a scale Standard Deviation 0.86	—

PRIMARY outcome

Timeframe: Baseline

Population: The number of participants analyzed at 6 months is lower than those who were analyzed at baseline due to participants lost to follow-up.

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

Outcome measures

Outcome measures
Measure	Health Education Initiative n=49 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=34 Participants Participants in this group will not receive any health education and total participation is up to 6 months.
Number of Caregivers Who Received COVID-19 Vaccine	35 Participants	24 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The number of participants analyzed at baseline differs from the number analyzed at 6 months because participants were lost to follow-up.

unit of measure number of children

Outcome measures

Outcome measures
Measure	Health Education Initiative n=52 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=35 Participants Participants in this group will not receive any health education and total participation is up to 6 months.
Number of Children Who Received COVID-19 Vaccine	23 Participants	18 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The number of participants analyzed differ between baseline and 6 months because participants were lost to follow-up.

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.

Outcome measures

Outcome measures
Measure	Health Education Initiative n=61 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=34 Participants Participants in this group will not receive any health education and total participation is up to 6 months.
Health Behaviors as Measured by Health Behavior Questionnaire	4.10 score on a scale Standard Deviation 1.10	3.76 score on a scale Standard Deviation 1.37

PRIMARY outcome

Timeframe: 6 months

Population: The number of participants analyzed at 6 months is lower than those who were analyzed at baseline due to participants lost to follow-up.

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

Outcome measures

Outcome measures
Measure	Health Education Initiative n=29 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=17 Participants Participants in this group will not receive any health education and total participation is up to 6 months.
Number of Caregivers Who Received COVID-19 Vaccine	18 Participants	7 Participants

PRIMARY outcome

Timeframe: 6 month

Population: The number of participants analyzed differ between baseline and 6 months because participants were lost to follow-up.

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.

Outcome measures

Outcome measures
Measure	Health Education Initiative n=33 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=18 Participants Participants in this group will not receive any health education and total participation is up to 6 months.
Health Behaviors as Measured by Health Behavior Questionnaire	4.09 score on a scale Standard Deviation 0.82	3.96 score on a scale Standard Deviation 1.18

PRIMARY outcome

Timeframe: 6 months

Population: The number of participants analyzed at baseline differs from the number analyzed at 6 months because participants were lost to follow-up.

unit of measure number of children

Outcome measures

Outcome measures
Measure	Health Education Initiative n=28 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=16 Participants Participants in this group will not receive any health education and total participation is up to 6 months.
Number of Children Who Received COVID-19 Vaccine	11 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, 6 month follow up

Population: The number of participants analyzed at baseline is lower than the overall number of participants, because some participants did not complete their packet of questionnaires, including the present measure. There were fewer participants at the 6-month follow-up because participants were lost to 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".

Outcome measures

Outcome measures
Measure	Health Education Initiative n=29 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=35 Participants Participants in this group will not receive any health education and total participation is up to 6 months.
PTSD as Measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD) 6 month follow up	4.6 score on a scale Standard Deviation 6.7	7.74 score on a scale Standard Deviation 8.27
PTSD as Measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD) Baseline	5.83 score on a scale Standard Deviation 6.49	5.77 score on a scale Standard Deviation 8.63

SECONDARY outcome

Timeframe: Baseline, 6 month follow up

Population: The number of participants analyzed at baseline is lower than the overall number of participants, because some participants did not complete their packet of questionnaires, including the present measure. There were fewer participants at the 6-month follow-up because participants were lost to 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".

Outcome measures

Outcome measures
Measure	Health Education Initiative n=29 Participants Participants will receive the health education session for up to 6 months. 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.	Control Group n=35 Participants Participants in this group will not receive any health education and total participation is up to 6 months.
COVID Anxiety as Measured by the Coronavirus Anxiety Scale Baseline	0.21 score on a scale Standard Deviation 0.62	1.37 score on a scale Standard Deviation 3.95
COVID Anxiety as Measured by the Coronavirus Anxiety Scale 6 month follow up	0.83 score on a scale Standard Deviation 2.28	0.42 score on a scale Standard Deviation 1.22

Adverse Events

Health Education Initiative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lisa Gwynn

University of Miami

Phone: 305-243-3440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place