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临床试验/NCT06036134
NCT06036134已完成不适用

Reducing Vaccine Hesitancy Among Hispanic Parents of COVID-19 Vaccine-Eligible Children

Arizona State University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Parental COVID-19 vaccine hesitancy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •individuals who do not meet inclusion criteria or are unable/ unwilling to provide consent.

研究组 & 干预措施

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).

干预措施: Baseline surveys (Behavioral)

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).

干预措施: Digital Storytelling Intervention (Behavioral)

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).

干预措施: Baseline surveys (Behavioral)

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).

干预措施: Information Control Intervention (Behavioral)

结局指标

主要结局

Parental COVID-19 vaccine hesitancy

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Parents' perceived behavioral control to vaccinate their child(ren) against COVID-19(Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention))
  • Parents' attitudes about vaccinating their child(ren) against COVID-19(Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention))
  • Parents' perceived norms about vaccinating their child(ren) against COVID-19(Baseline (T1), T2 (after 4-week intervention), and T3 (2-months post-intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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