Playing Games to Learn About Children's Vaccines Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Randomized Controlled Study to Examine Feasibility and Preliminary Effectiveness of Game-based Interventions in Promoting Vaccination Among Vulnerable Youth

Conditions
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HPV, COVID-19, Vaccine-Preventable Diseases

Intervention / Treatment
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* Behavioral: vaccination games


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV game group<br>parent-child dyads receive HPV game intervention | Behavioral: vaccination games<br>* Brief health games to promote two different vaccines among youth<br>|
| Experimental: COVID game group<br>parent-child dyads receive COVID game intervention | Behavioral: vaccination games<br>* Brief health games to promote two different vaccines among youth<br>|
| No Intervention: Usual care<br>parent-child dyads receive usual care (no intervention) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of eligible individuals agreeing to participate | Assessed by the % of eligible individuals agreeing to participate | T0 (occurs after consenting and before assigning to different study conditions) | 
| Proportion of participants who are retained through follow-up | Assessed by the % of participants who are retained through follow-up | T2 (occurs two months after completion of the intervention) | 
| Percentage of participants who complete the intervention and assessments | Assessed by the % of participants who complete the intervention and assessments | T2 (occurs two months after completion of the intervention) | 
| Participant satisfaction with the project | 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) | T2 (occurs two months after completion of the intervention) | 
| Intention to vaccinate the children against HPV | Assessed by a Likert scale question: How likely will you (parent) vaccinate your child against HPV? Responses: (1) very unlikely to (5) very likely | T0 (occurs after consenting and before assigning to different study conditions); T1 (occurs immediately post intervention);T2 (occurs two months after completion of the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children receives the first dose of HPV vaccine | Assessed by one binary question regarding whether or not the child has received the first dose of HPV vaccine. Responses: yes, no | T2 (occurs two months after completion of the intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent, game intervention