COVID-19
Conditions
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.
Interventions
BEHAVIORALHealth 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Confidence in COVID Healthcare Decision Making as Measured by COVID Confidence Questionnaire | 6 months | Scores range from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating more knowledge, value, application, or satisfaction. |
| Number of Children Who Received COVID-19 Vaccine | Baseline | unit of measure number of children |
| Health Behaviors as Measured by Health Behavior Questionnaire | 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. |
| Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire | 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. |
| Number of Caregivers Who Received COVID-19 Vaccine | Baseline | The unit of measure is the number of caregivers who received COVID-19 vaccine at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID Anxiety as Measured by the Coronavirus Anxiety Scale | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 76 |
| Control Group Participants in this group will not receive any health education and total participation is up to 6 months. | 36 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 56 | 18 |
Baseline characteristics
| Characteristic | Control Group | Total | Health Education Initiative |
|---|---|---|---|
| Age, Continuous | 41.69 years STANDARD_DEVIATION 7.85 | 42.89 years STANDARD_DEVIATION 8.14 | 44.34 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 48 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 52 Participants | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 46 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 51 Participants | 49 Participants |
| Race (NIH/OMB) White | 5 Participants | 13 Participants | 8 Participants |
| Sex: Female, Male Female | 32 Participants | 58 Participants | 26 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 36 |
| other Total, other adverse events | 0 / 76 | 0 / 36 |
| serious Total, serious adverse events | 0 / 76 | 0 / 36 |
Outcome results
Primary
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.
Time frame: Baseline
Population: This was data collection only for the health education initiative. The control group did not participate in this section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Education Initiative | Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire | 4.47 score on a scale | Standard Deviation 0.89 |
Primary
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.
Time frame: 6 months
Population: This was only administered to the intervention group. No control participants were analyzed because they did not receive this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Education Initiative | 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
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.
Time frame: Baseline
Population: The number of participants analyzed differ between baseline and 6 months because participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Education Initiative | Health Behaviors as Measured by Health Behavior Questionnaire | 4.10 score on a scale | Standard Deviation 1.1 |
| Control Group | Health Behaviors as Measured by Health Behavior Questionnaire | 3.76 score on a scale | Standard Deviation 1.37 |
Primary
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.
Time frame: 6 month
Population: The number of participants analyzed differ between baseline and 6 months because participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Education Initiative | Health Behaviors as Measured by Health Behavior Questionnaire | 4.09 score on a scale | Standard Deviation 0.82 |
| Control Group | Health Behaviors as Measured by Health Behavior Questionnaire | 3.96 score on a scale | Standard Deviation 1.18 |
Primary
Number of Caregivers Who Received COVID-19 Vaccine
The unit of measure is the number of caregivers who received COVID-19 vaccine
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Education Initiative | Number of Caregivers Who Received COVID-19 Vaccine | 18 Participants |
| Control Group | Number of Caregivers Who Received COVID-19 Vaccine | 7 Participants |
Primary
Number of Caregivers Who Received COVID-19 Vaccine
The unit of measure is the number of caregivers who received COVID-19 vaccine at baseline
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Education Initiative | Number of Caregivers Who Received COVID-19 Vaccine | 35 Participants |
| Control Group | Number of Caregivers Who Received COVID-19 Vaccine | 24 Participants |
Primary
Number of Children Who Received COVID-19 Vaccine
unit of measure number of children
Time frame: Baseline
Population: The number of participants analyzed at baseline differs from the number analyzed at 6 months because participants were lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Education Initiative | Number of Children Who Received COVID-19 Vaccine | 23 Participants |
| Control Group | Number of Children Who Received COVID-19 Vaccine | 18 Participants |
Primary
Number of Children Who Received COVID-19 Vaccine
unit of measure number of children
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Education Initiative | Number of Children Who Received COVID-19 Vaccine | 11 Participants |
| Control Group | Number of Children Who Received COVID-19 Vaccine | 5 Participants |
Secondary
COVID Anxiety as Measured by the Coronavirus Anxiety Scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Education Initiative | COVID Anxiety as Measured by the Coronavirus Anxiety Scale | Baseline | 0.21 score on a scale | Standard Deviation 0.62 |
| Health Education Initiative | COVID Anxiety as Measured by the Coronavirus Anxiety Scale | 6 month follow up | 0.83 score on a scale | Standard Deviation 2.28 |
| Control Group | COVID Anxiety as Measured by the Coronavirus Anxiety Scale | Baseline | 1.37 score on a scale | Standard Deviation 3.95 |
| Control Group | COVID Anxiety as Measured by the Coronavirus Anxiety Scale | 6 month follow up | 0.42 score on a scale | Standard Deviation 1.22 |
Secondary
PTSD as Measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Education Initiative | 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 |
| Health Education Initiative | 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 |
| Control Group | PTSD as Measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD) | Baseline | 5.77 score on a scale | Standard Deviation 8.63 |
| Control Group | 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 | 7.74 score on a scale | Standard Deviation 8.27 |