Reducing COVID-19 Vaccine Hesitancy Among Hispanic Parents

NCT06036134 | Completed DMC

• 2 other identifiers: STUDY00017735R21HD110837
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic; Vaccine-Preventable Diseases; Health-Related Behavior; Health Knowledge, Attitudes, Practice; Narration

Keywords

COVID-19 Vaccine; Digital storytelling; Hispanic children; Vaccine hesitancy; Health disparities

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  T3 (2-months post-intervention)

Secondary Outcomes (3)

• 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)

• 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)

Study Arms (2)

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).

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).

Behavioral: Baseline surveys; Behavioral: Information Control Intervention

Interventions

Baseline surveys BEHAVIORAL

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,

Also known as: Baseline questionnaire

Baseline and Control; Baseline and Digital Storytelling (DST)

Digital Storytelling Intervention BEHAVIORAL

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.

Also known as: Digital Storytelling, Storytelling

Baseline and Digital Storytelling (DST)

Information Control Intervention BEHAVIORAL

The control group participants will receive a CDC COVID-19 vaccine information sheet appropriate for their child's age.

Also known as: Control Intervention

Baseline and Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Vaccine-Preventable Diseases; COVID-19; Health Behavior; Behavior; Narration; Vaccination Hesitancy

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Communication; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexis Koskan, Ph.D

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Sunny W Kim, Ph.D

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: December 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)