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Reducing COVID-19 Vaccine Hesitancy Among Hispanic Parents

Primary Purpose

Vaccine-Preventable Diseases, COVID-19 Pandemic, Health-Related Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baseline surveys
Digital Storytelling Intervention
Information Control Intervention
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccine-Preventable Diseases focused on measuring COVID-19 Vaccine, Digital storytelling, Hispanic children, Vaccine hesitancy, Health disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: individuals who do not meet inclusion criteria or are unable/ unwilling to provide consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Baseline and Digital Storytelling (DST)

    Baseline and Control

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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).
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    September 5, 2023
    Last Updated
    September 12, 2023
    Sponsor
    Arizona State University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06036134
    Brief Title
    Reducing COVID-19 Vaccine Hesitancy Among Hispanic Parents
    Official Title
    Reducing Vaccine Hesitancy Among Hispanic Parents of COVID-19 Vaccine-Eligible Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    January 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Arizona State University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Baseline and Digital Storytelling (DST)
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Baseline and Control
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Baseline surveys
    Other Intervention Name(s)
    Baseline questionnaire
    Intervention Description
    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,
    Intervention Type
    Behavioral
    Intervention Name(s)
    Digital Storytelling Intervention
    Other Intervention Name(s)
    Digital Storytelling, Storytelling
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Information Control Intervention
    Other Intervention Name(s)
    Control Intervention
    Intervention Description
    The control group participants will receive a CDC COVID-19 vaccine information sheet appropriate for their child's age.
    Primary Outcome Measure Information:
    Title
    Parental COVID-19 vaccine hesitancy
    Description
    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).
    Time Frame
    Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
    Title
    Intentions to vaccinate child(ren) against COVID-19
    Description
    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.
    Time Frame
    Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
    Title
    Child's COVID-19 vaccine uptake
    Description
    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.
    Time Frame
    T3 (2-months post-intervention)
    Secondary Outcome Measure Information:
    Title
    Parents' attitudes about vaccinating their child(ren) against COVID-19
    Description
    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.
    Time Frame
    Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
    Title
    Parents' perceived norms about vaccinating their child(ren) against COVID-19
    Description
    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.
    Time Frame
    Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)
    Title
    Parents' perceived behavioral control to vaccinate their child(ren) against COVID-19
    Description
    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.
    Time Frame
    Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: individuals who do not meet inclusion criteria or are unable/ unwilling to provide consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexis Koskan, Ph.D
    Phone
    602-496-6789
    Email
    Alexis.Koskan@asu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sunny W Kim, Ph.D
    Phone
    602-496-6789
    Email
    Sunny.Kim@asu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexis Koskan, Ph.D
    Organizational Affiliation
    Arizona State University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sunny W Kim, Ph.D
    Organizational Affiliation
    Arizona State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Reducing COVID-19 Vaccine Hesitancy Among Hispanic Parents

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