Clinical trial NCT05984849: 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
Overall status: RECRUITING
Phase: NA
Conditions: HPV
COVID-19
Vaccine-Preventable Diseases
Keywords: adolescent
game intervention
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 180
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Percentage of eligible individuals agreeing to participate
timeFrame: T0 (occurs after consenting and before assigning to different study conditions)
measure: Proportion of participants who are retained through follow-up
timeFrame: T2 (occurs two months after completion of the intervention)
measure: Percentage of participants who complete the intervention and assessments
timeFrame: T2 (occurs two months after completion of the intervention)
measure: Participant satisfaction with the project
timeFrame: T2 (occurs two months after completion of the intervention)
measure: Intention to vaccinate the children against HPV
timeFrame: 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 outcomes:
measure: Children receives the first dose of HPV vaccine
timeFrame: T2 (occurs two months after completion of the intervention)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Community
state: Arizona
Study officials:
affiliation: Michigan State University
name: ANGELA CHEN, PhD
role: PRINCIPAL_INVESTIGATOR
References: