Playing Games to Learn About Children's Vaccines Project

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984849
• Other study ID #: FP00033005
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: Michigan State University
• Contact: ANGELA CHEN, PhD
• Phone: 480) 253-9098
• Email: Healthandgame[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• HPV

Intervention

Behavioral:
• vaccination games
Brief health games to promote two different vaccines among youth

Locations

Country	Name	City	State
United States	Community	Chandler	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)