Vaccine-Preventable DiseasesNCT06036134
Reducing COVID-19 Vaccine Hesitancy Among Hispanic Parents
A study testing Baseline surveys and Digital Storytelling Intervention in people with Vaccine-Preventable Diseases and COVID-19 Pandemic, run by Arizona State University at 1 site in United States.
Trial summary
COVID-19 vaccines are available to children over six months, and these vaccines are powerful tools against this catastrophic pandemic. However, Hispanic/Latino children have lower COVID-19 vaccination rates than White non-Hispanic children .Our team of health communication and public health experts proposes a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine-Preventable Diseases, COVID-19 Pandemic, Health-Related Behavior
- What is being tested?
- Baseline surveys and Digital Storytelling Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identifies as Hispanic
- is a biological parent or a legal guardian of at least one child under 18 years old
- their child(ren) are not vaccinated against up-to-date with COVID-19 vaccine doses
- agrees to send and receive a text message and submit a photo of their child's immunization record for T3 data collection.
Who cannot join
- individuals who do not meet inclusion criteria or are unable/ unwilling to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Vaccine Hesitancy Among Hispanic Parents of COVID-19 Vaccine-Eligible Children
COVID-19 vaccines are available to children over six months, and these vaccines are powerful tools against this catastrophic pandemic. However, Hispanic/Latino children have lower COVID-19 vaccination rates than White non-Hispanic children .Our team of health communication and public health experts proposes a community-based theory-driven intervention that utilizes culturally-grounded narratives from digital storytelling to reduce Hispanic parents' COVID-19 vaccine hesitancy and increase their children's vaccine uptake.
Read the detailed description
Among children and adolescents, infection with SARS-CoV-2 (COVID-19) can lead to health complications (e.g., multisystem inflammatory syndrome, long COVID), hospitalizations, and death. COVID-19 vaccines are available to children over six months, and these vaccines are powerful tools against this catastrophic pandemic. However, Hispanic/Latino children have lower COVID-19 vaccination rates than White non-Hispanic children3 In most southwestern U.S. states, Hispanic children have the lowest COVID-19 vaccination rates among pediatric populations. Lower vaccination rates in children are primarily due to parental vaccine hesitancy. Considerably more work is needed to decrease parental COVID-19 vaccine hesitancy among Hispanic parents.
Narrative-based interventions are powerful tools for persuading individuals to enact health behaviors (vaccination) that require an immediate personal cost (discomfort) for a longer-term gain (disease immunity). Our current study will examine digital storytelling (DST), a specific form of culturally-grounded narrative developed via community engagement, to reduce Hispanic parents' COVID-19 vaccine hesitancy. No research, to our knowledge, has used digital stories to decrease Hispanic parents' vaccine hesitancy. Therefore, it is critical to assess which stories resonate with and are most persuasive for those who are hesitant to have their children receive COVID-19 doses and then explore the impact of an intervention utilizing these stories on parents' decisions to vaccinate their children against COVID-19.
Specific Aims:
Aim 1: Develop one digital story per participant (n=10; each story lasting 2-3 minutes) in a DST workshop with a sample of Hispanic parents/ legal guardians converted from being COVID-19 vaccine-hesitant to vaccine-accepting.
Aim 2: Assess the feasibility and acceptability of a web-based pilot DST intervention vs. an information-only control among Hispanic parents and legal guardians (n=80) of children who are not up-to-date with CDC-recommended COVID-19 vaccine doses.
Exploratory aim: The investigators will explore intervention and control group participants' (n=80) patterns of pre- to post-intervention change in vaccine uptake perceptions, vaccine hesitancy, intentions to vaccinate children against COVID-19, and children's vaccine uptake at two months post-intervention.
- Conditions
- Vaccine-Preventable Diseases, COVID-19 Pandemic, Health-Related Behavior, Health Knowledge, Attitudes, Practice, Narration
- Being tested
- Baseline surveys, Digital Storytelling Intervention, Information Control Intervention
- Keywords
- COVID-19 Vaccine, Digital storytelling, Hispanic children, Vaccine hesitancy, Health disparities
- Medical subject headings
- Vaccine-Preventable Diseases, COVID-19, Health Behavior, Behavior, Narration, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline surveysBehavioural
Also called Baseline questionnaire
Baseline surveys contained a series of scaled questions, including sociodemographic variables (age, gender, income, education level, relationship to the child), parental COVID-19 vaccine hesitancy, intentions to vaccinate child against COVID-19, and parents' attitudes, perceived norms, and perceived behavioral control about vaccinating their child against COVID-19,
Digital Storytelling InterventionBehavioural
Also called Digital Storytelling, Storytelling
In Aim 1, the investigators are creating intervention materials for Study Aim 2. These intervention materials include ten digital stories (each 2-3 minutes long) with a diverse sample of Hispanic parents and legal guardians who transformed from being COVID-19 vaccine-hesitant to vaccine-accepting. Each story uses individuals' own brief first-person visual narratives/stories that use digital images, audio recordings, music, and text to document personal experiences.
Information Control InterventionBehavioural
Also called Control Intervention
The control group participants will receive a CDC COVID-19 vaccine information sheet appropriate for their child's age.
| Study group | Role | What they receive |
|---|---|---|
| Baseline and Digital Storytelling (DST) | Experimental | Once participants complete the consent, they will be asked to complete a baseline assessment using the web-based data collection platform, Research Electronic Data Capture before the random assignment to DST arm. The intervention group participants will watch the four selected digital stories about COVID-19 vaccine experiences among Hispanic parents of children. Each story was made with voice, images, and sound (3-5 minutes each). Intervention group participants will complete the Time 2 (T2) online survey immediately after the DST intervention. Two months later, the investigators will contact all participants and ask them to complete another follow-up (T3) assessment of participants' vaccine hesitancy and COVID-19 vaccination behaviors (since T1 and T2). Receives: Behavioral: Baseline surveys; Behavioral: Digital Storytelling Intervention |
| Baseline and Control | Active comparator | Once participants complete the consent, they will be asked to complete a baseline assessment using the web-based data collection platform, Research Electronic Data Capture before the random assignment to control arm. Control group participants will receive a CDC COVID-19 Vaccine Information Sheet appropriate for their child's age before completing the T2 assessment. Two months later, the investigators will contact all participants and ask them to complete another follow-up (T3) assessment of participants' vaccine hesitancy and COVID-19 vaccination behaviors (since T1 and T2). Receives: Behavioral: Baseline surveys; Behavioral: Information Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental COVID-19 vaccine hesitancy
Parental COVID-19 vaccine hesitancy will be measured at three time points. The investigators will use a modified version of the Parent Attitudes About Childhood Vaccines (PACV) Survey to assess changes in parental vaccine hesitancy (15 items). Scores range from 0-30, with more points equating to greater vaccine hesitancy. For all responses, vaccine-hesitant responses are equal to 2 points, neutral or unsure responses are worth 1 point, and non-hesitant responses are worth 0 points. There are 2 questions which require a slider response. For these two questions, scores of 0-5 signify vaccine hesitancy (2 points), 6-7 signify unsure/neutral responses (1 point), and 8-10 illustrate non-hesitant scores (0 points).
Measured: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Intentions to vaccinate child(ren) against COVID-19
Measured via a previously validated survey item based on Theory of Planned Behavior constructs, updated to reflect COVID-19 vaccination among children. There is one question about parents' intentions to vaccinate their children. The response option is a 7-point Likert Scale (1 = strongly disagree, 4 = neither disagree nor agree, 7 = strongly agree), with 1 signifying no intention to vaccinate and 7 signifying the parent is very likely to vaccinate their child(ren). Higher scores indicate great intentions to vaccinate children against COVID-19.
Measured: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Child's COVID-19 vaccine uptake
Measured with two items (yes/no response options) with one question assessing whether children have received 1 or more doses of COVID-19 vaccines over the past two months. Affirmative responses will equal one point, and "no" responses will equal no points.
Measured: T3 (2-months post-intervention)
Secondary outcomes (3)
Parents' attitudes about vaccinating their child(ren) against COVID-19
Measured via a previously validated survey updated to reflect COVID-19 vaccination among children, five items measuring vaccine attitudes (α = 0.833). The response options are 7-point Likert Scale (1 = strongly disagree, 4 = neither disagree nor agree,7 = strongly agree), with 1 signifying their negative attitude about vaccinating children against COVID-19, and 7 with more positive attitudes about vaccinating against COVID-19. One item is reverse-coded. Therefore, scores range from 5-35, with higher scores indicating more positive attitudes about vaccinating their children against COVID-19.
Measured: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Parents' perceived norms about vaccinating their child(ren) against COVID-19
Measured via a previously validated survey updated to reflect COVID-19 vaccination among children, five items measuring perceived norms, (α = 0.899). The response options are 7-point Likert Scale (1 = strongly disagree, 4 = neither disagree nor agree,7 = strongly agree), with 1 signifying a lack of perceived norms about vaccinating children against COVID-19, and 7 with stronger perceived norms about vaccinating against COVID-19. Therefore, scores range from 5-35, with higher scores indicating stronger perceived norms about vaccinating their children against COVID-19.
Measured: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Parents' perceived behavioral control to vaccinate their child(ren) against COVID-19
Measured via a previously validated survey updated to reflect COVID-19 vaccination among children, four items assessing perceived behavioral control (α = 0.785). The response options are 7-point Likert Scale (1 = strongly disagree, 4 = neither disagree nor agree,7 = strongly agree), with 1 signifying a lack of perceived behavioral control about vaccinating children against COVID-19, and 7 with stronger perceived behavioral control about vaccinating against COVID-19. Therefore, scores range from 4-28, with higher scores indicating stronger perceived norms about vaccinating their children against COVID-19.
Measured: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Dec 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine-Preventable DiseasesStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Alexis Koskan, Ph.D, Principal investigator, Arizona State UniversitySunny W Kim, Ph.D, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036134
- Sponsor's protocol ID
- STUDY00017735
- Other IDs
- R21HD110837
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Vaccine Hesitancy Among Hispanic Parents of COVID-19 Vaccine-Eligible Children
- ClinicalTrials.gov ID
- NCT06036134
- Acronym / sponsor ID
- STUDY00017735
- Conditions
- Vaccine-Preventable Diseases, COVID-19 Pandemic, Health-Related Behavior, Health Knowledge, Attitudes, Practice, Narration
- Keywords
- COVID-19 Vaccine, Digital storytelling, Hispanic children, Vaccine hesitancy, Health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COVID-19 vaccines are available to children over six months, and these vaccines are powerful tools against this catastrophic pandemic. However, Hispanic/Latino children have lower COVID-19 vaccination rates than White non-Hispanic children .Our team of health communication and public health experts proposes a community-based theory-driven intervention that utilizes culturally-grounded narratives from digital storytelling to reduce Hispanic parents' COVID-19 vaccine hesitancy and increase their children's vaccine uptake.
Detailed description
Among children and adolescents, infection with SARS-CoV-2 (COVID-19) can lead to health complications (e.g., multisystem inflammatory syndrome, long COVID), hospitalizations, and death. COVID-19 vaccines are available to children over six months, and these vaccines are powerful tools against this catastrophic pandemic. However, Hispanic/Latino children have lower COVID-19 vaccination rates than White non-Hispanic children3 In most southwestern U.S. states, Hispanic children have the lowest COVID-19 vaccination rates among pediatric populations. Lower vaccination rates in children are primarily due to parental vaccine hesitancy. Considerably more work is needed to decrease parental COVID-19 vaccine hesitancy among Hispanic parents.
Narrative-based interventions are powerful tools for persuading individuals to enact health behaviors (vaccination) that require an immediate personal cost (discomfort) for a longer-term gain (disease immunity). Our current study will examine digital storytelling (DST), a specific form of culturally-grounded narrative developed via community engagement, to reduce Hispanic parents' COVID-19 vaccine hesitancy. No research, to our knowledge, has used digital stories to decrease Hispanic parents' vaccine hesitancy. Therefore, it is critical to assess which stories resonate with and are most persuasive for those who are hesitant to have their children receive COVID-19 doses and then explore the impact of an intervention utilizing these stories on parents' decisions to vaccinate their children against COVID-19.
Specific Aims:
Aim 1: Develop one digital story per participant (n=10; each story lasting 2-3 minutes) in a DST workshop with a sample of Hispanic parents/ legal guardians converted from being COVID-19 vaccine-hesitant to vaccine-accepting.
Aim 2: Assess the feasibility and acceptability of a web-based pilot DST intervention vs. an information-only control among Hispanic parents and legal guardians (n=80) of children who are not up-to-date with CDC-recommended COVID-19 vaccine doses.
Exploratory aim: The investigators will explore intervention and control group participants' (n=80) patterns of pre- to post-intervention change in vaccine uptake perceptions, vaccine hesitancy, intentions to vaccinate children against COVID-19, and children's vaccine uptake at two months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline and Digital Storytelling (DST) | Experimental | Behavioral: Baseline surveys, Behavioral: Digital Storytelling InterventionOnce participants complete the consent, they will be asked to complete a baseline assessment using the web-based data collection platform, Research Electronic Data Capture before the random assignment to DST arm. The intervention group participants will watch the four selected digital stories about COVID-19 vaccine experiences among Hispanic parents of children. Each story was made with voice, images, and sound (3-5 minutes each). Intervention group participants will complete the Time 2 (T2) online survey immediately after the DST intervention. Two months later, the investigators will contact all participants and ask them to complete another follow-up (T3) assessment of participants' vaccine hesitancy and COVID-19 vaccination behaviors (since T1 and T2). |
| Baseline and Control | Active comparator | Behavioral: Baseline surveys, Behavioral: Information Control InterventionOnce participants complete the consent, they will be asked to complete a baseline assessment using the web-based data collection platform, Research Electronic Data Capture before the random assignment to control arm. Control group participants will receive a CDC COVID-19 Vaccine Information Sheet appropriate for their child's age before completing the T2 assessment. Two months later, the investigators will contact all participants and ask them to complete another follow-up (T3) assessment of participants' vaccine hesitancy and COVID-19 vaccination behaviors (since T1 and T2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-identifies as Hispanic
- is a biological parent or a legal guardian of at least one child under 18 years old
- their child(ren) are not vaccinated against up-to-date with COVID-19 vaccine doses
- agrees to send and receive a text message and submit a photo of their child's immunization record for T3 data collection.
Key exclusion criteria (1 listed)
- individuals who do not meet inclusion criteria or are unable/ unwilling to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline surveysAlso: Baseline questionnaireBaseline surveys contained a series of scaled questions, including sociodemographic variables (age, gender, income, education level, relationship to the child), parental COVID-19 vaccine hesitancy, intentions to vaccinate child against COVID-19, and parents' attitudes, perceived norms, and perceived behavioral control about vaccinating their child against COVID-19, | Behavioural | Baseline and Control, Baseline and Digital Storytelling (DST) |
| Digital Storytelling InterventionAlso: Digital Storytelling, StorytellingIn Aim 1, the investigators are creating intervention materials for Study Aim 2. These intervention materials include ten digital stories (each 2-3 minutes long) with a diverse sample of Hispanic parents and legal guardians who transformed from being COVID-19 vaccine-hesitant to vaccine-accepting. Each story uses individuals' own brief first-person visual narratives/stories that use digital images, audio recordings, music, and text to document personal experiences. | Behavioural | Baseline and Digital Storytelling (DST) |
| Information Control InterventionAlso: Control InterventionThe control group participants will receive a CDC COVID-19 vaccine information sheet appropriate for their child's age. | Behavioural | Baseline and Control |
Primary outcome
Parental COVID-19 vaccine hesitancy
Time frame: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Parental COVID-19 vaccine hesitancy will be measured at three time points. The investigators will use a modified version of the Parent Attitudes About Childhood Vaccines (PACV) Survey to assess changes in parental vaccine hesitancy (15 items). Scores range from 0-30, with more points equating to greater vaccine hesitancy. For all responses, vaccine-hesitant responses are equal to 2 points, neutral or unsure responses are worth 1 point, and non-hesitant responses are worth 0 points. There are 2 questions which require a slider response. For these two questions, scores of 0-5 signify vaccine hesitancy (2 points), 6-7 signify unsure/neutral responses (1 point), and 8-10 illustrate non-hesitant scores (0 points).
Intentions to vaccinate child(ren) against COVID-19
Time frame: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Measured via a previously validated survey item based on Theory of Planned Behavior constructs, updated to reflect COVID-19 vaccination among children. There is one question about parents' intentions to vaccinate their children. The response option is a 7-point Likert Scale (1 = strongly disagree, 4 = neither disagree nor agree, 7 = strongly agree), with 1 signifying no intention to vaccinate and 7 signifying the parent is very likely to vaccinate their child(ren). Higher scores indicate great intentions to vaccinate children against COVID-19.
Child's COVID-19 vaccine uptake
Time frame: T3 (2-months post-intervention)
Measured with two items (yes/no response options) with one question assessing whether children have received 1 or more doses of COVID-19 vaccines over the past two months. Affirmative responses will equal one point, and "no" responses will equal no points.
3 secondary outcomes
Parents' attitudes about vaccinating their child(ren) against COVID-19
Time frame: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Parents' perceived norms about vaccinating their child(ren) against COVID-19
Time frame: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Parents' perceived behavioral control to vaccinate their child(ren) against COVID-19
Time frame: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Koskan, Ph.D principal investigator
Arizona State University
Sunny W Kim, Ph.D principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline surveys and Digital Storytelling Intervention in people with Vaccine-Preventable Diseases and COVID-19 Pandemic, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental COVID-19 vaccine hesitancy (time frame: Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.