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Playing Games to Learn About Children's Vaccines Project

Primary Purpose

HPV, COVID-19, Vaccine-Preventable Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vaccination games
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HPV focused on measuring adolescent, game intervention

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CommunityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

HPV game group

COVID game group

Usual care

Arm Description

parent-child dyads receive HPV game intervention

parent-child dyads receive COVID game intervention

parent-child dyads receive usual care (no intervention)

Outcomes

Primary Outcome Measures

Percentage of eligible individuals agreeing to participate
Assessed by the % of eligible individuals agreeing to participate
Proportion of participants who are retained through follow-up
Assessed by the % of participants who are retained through follow-up
Percentage of participants who complete the intervention and assessments
Assessed by the % of participants who complete the intervention and assessments
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)
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

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2023
Last Updated
August 2, 2023
Sponsor
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT05984849
Brief Title
Playing Games to Learn About Children's Vaccines Project
Official Title
A Pilot Randomized Controlled Study to Examine Feasibility and Preliminary Effectiveness of Game-based Interventions in Promoting Vaccination Among Vulnerable Youth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV, COVID-19, Vaccine-Preventable Diseases
Keywords
adolescent, game intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HPV game group
Arm Type
Experimental
Arm Description
parent-child dyads receive HPV game intervention
Arm Title
COVID game group
Arm Type
Experimental
Arm Description
parent-child dyads receive COVID game intervention
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
parent-child dyads receive usual care (no intervention)
Intervention Type
Behavioral
Intervention Name(s)
vaccination games
Intervention Description
Brief health games to promote two different vaccines among youth
Primary Outcome Measure Information:
Title
Percentage of eligible individuals agreeing to participate
Description
Assessed by the % of eligible individuals agreeing to participate
Time Frame
T0 (occurs after consenting and before assigning to different study conditions)
Title
Proportion of participants who are retained through follow-up
Description
Assessed by the % of participants who are retained through follow-up
Time Frame
T2 (occurs two months after completion of the intervention)
Title
Percentage of participants who complete the intervention and assessments
Description
Assessed by the % of participants who complete the intervention and assessments
Time Frame
T2 (occurs two months after completion of the intervention)
Title
Participant satisfaction with the project
Description
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)
Time Frame
T2 (occurs two months after completion of the intervention)
Title
Intention to vaccinate the children against HPV
Description
Assessed by a Likert scale question: How likely will you (parent) vaccinate your child against HPV? Responses: (1) very unlikely to (5) very likely
Time Frame
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 Measure Information:
Title
Children receives the first dose of HPV vaccine
Description
Assessed by one binary question regarding whether or not the child has received the first dose of HPV vaccine. Responses: yes, no
Time Frame
T2 (occurs two months after completion of the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANGELA CHEN, PhD
Phone
480) 253-9098
Email
Healthandgame@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lihong Ou, MS
Phone
480) 253-9098
Email
Healthandgame@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANGELA CHEN, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANGELA CHEN
Phone
480-253-9098
Email
Healthandgame@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Playing Games to Learn About Children's Vaccines Project

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