Playing Game to Learn About Children's Vaccine Project

NCT ID: NCT05984849

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-08-31

Brief Summary

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This proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of one strongly recommended vaccine with suboptimal uptake rates: Human papillomavirus (HPV) 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 one game-based interventions targeting HPV vaccination.

Objective 2: Conduct a pilot RCT with three conditions (Arm 1: HPV game-based intervention; Arm 2: 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.

Conditions

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HPV Vaccine-Preventable Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HPV game group

parent-child dyads receive HPV game intervention

Group Type EXPERIMENTAL

vaccination game

Intervention Type BEHAVIORAL

A health game to promote HPV vaccination among youth

Usual care

parent-child dyads receive usual care (no intervention)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vaccination game

A health game to promote HPV vaccination among youth

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Child sample: (1) 11-14 years old, (2) speaks and reads English, (3) has never received any doses of the HPV vaccine, (4) is not currently enrolled in another project that involves HPV-related education, and (5) agrees and provides assent to participate in research activities.
* Parent sample: (1) parent or legal guardian of the participating child, (2) speak and read English, (3) own a smartphone, (4) agree to receive email and text messages, (5) is not currently enrolled in another project that involves HPV-related education, and (6) agree and provide consent to participate in research activities.
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Angela Chia-Chen Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANGELA C CHEN, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Community

Chandler, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ANGELA CHEN, PhD

Role: CONTACT

(517) 884-4645

Nouran Ghonaim, BS

Role: CONTACT

(517) 884-4645

Facility Contacts

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ANGELA CHEN

Role: primary

(480) 253-9098

Other Identifiers

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FP00033005

Identifier Type: -

Identifier Source: org_study_id

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