Vaccine Refusal
Conditions
Keywords
childhood vaccines, vaccine hesitancy, vaccination
Brief summary
The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.
Interventions
OTHERChildhood vaccination decision support tool
Participants receive childhood vaccination decision support tool
Sponsors
National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke. * Fluent in English
Exclusion criteria
* Unable to understand the study objectives, procedures, risks, and benefits * Unable to consent for themselves
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire | pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline) | Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention. |
| Change in Acceptability of Childhood Vaccinations | pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Childhood Vaccination Decision Support Tool Participants receive childhood vaccination decision support tool
Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Childhood Vaccination Decision Support Tool |
|---|---|
| Age, Continuous | 34.06 years STANDARD_DEVIATION 7.33 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 17 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Change in Acceptability of Childhood Vaccinations
Time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Population: Data not collected.
Primary
Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire
Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.
Time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Population: Participants who completed both questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Childhood Vaccination Decision Support Tool | Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire | 1.27 score on a scale | Standard Deviation 1.68 |