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Playing Games to Learn About Children's Vaccines Project

Not Applicable
Recruiting
Conditions
HPV
COVID-19
Vaccine-Preventable Diseases
Interventions
Behavioral: vaccination games
Registration Number
NCT05984849
Lead Sponsor
Michigan State University
Brief Summary

This proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of two strongly recommended vaccines with suboptimal uptake rates: Human papillomavirus (HPV) and COVID-19 in vulnerable and underserved youth aged 11-14.

Detailed Description

The study objectives are:

Objective 1: Assess feasibility (participation rate, retention, involvement, satisfaction) of two game-based interventions targeting HPV and COVID-19 vaccination.

Objective 2: Conduct a pilot RCT with three conditions (Arm 1: HPV game-based intervention; Arm 2: COVID-19 game-based intervention; Arm 3: usual care). The investigators will explore patterns of pre- to post-intervention change in theoretical mediators and vaccine intent, and explore levels of vaccine intent and uptake in 90 parent-child dyads of unvaccinated youth aged 11-14.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
180
Inclusion Criteria
  • Child sample: Individuals who (1) are aged 11-14 years, (2) have not received the 1st dose of HPV or COVID-19 vaccine, (3) can speak and read English, and (4) when approached, both parent and the child indicate that they do not plan or cannot decide whether the child will receive the HPV or COVID-19 vaccine.
  • Parent sample: Individuals who (1) are the parent/caregiver of the participating child, (2) agree to participate in the research activities. If more than one child in the same family is eligible for the study, the oldest one who has not received the HPV or COVID-19 vaccination will be recruited.
Exclusion Criteria
  • Individuals who do not meet inclusion criteria or refuse to provide consent/assent.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HPV game groupvaccination gamesparent-child dyads receive HPV game intervention
COVID game groupvaccination gamesparent-child dyads receive COVID game intervention
Primary Outcome Measures
NameTimeMethod
Proportion of participants who are retained through follow-upT2 (occurs two months after completion of the intervention)

Assessed by the % of participants who are retained through follow-up

Percentage of eligible individuals agreeing to participateT0 (occurs after consenting and before assigning to different study conditions)

Assessed by the % of eligible individuals agreeing to participate

Participant satisfaction with the projectT2 (occurs two months after completion of the intervention)

Assessed by two Likert scale questions: (1) are you satisfied with the program? (2) Will you recommend this program to others? Responses: from (1) very dissatisfied/definitely not to (5) very satisfied/definitely yes)

Intention to vaccinate the children against HPVT0 (occurs after consenting and before assigning to different study conditions); T1 (occurs immediately post intervention);T2 (occurs two months after completion of the intervention)

Assessed by a Likert scale question: How likely will you (parent) vaccinate your child against HPV? Responses: (1) very unlikely to (5) very likely

Percentage of participants who complete the intervention and assessmentsT2 (occurs two months after completion of the intervention)

Assessed by the % of participants who complete the intervention and assessments

Secondary Outcome Measures
NameTimeMethod
Children receives the first dose of HPV vaccineT2 (occurs two months after completion of the intervention)

Assessed by one binary question regarding whether or not the child has received the first dose of HPV vaccine. Responses: yes, no

Trial Locations

Locations (1)

Community

🇺🇸

Chandler, Arizona, United States

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