Pilot Testing of a Game-Based Intervention to Promote HPV Vaccination in Families With Unvaccinated Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Michigan State University
- Enrollment
- 133
- Locations
- 2
- Primary Endpoint
- Parent and child acceptability of the intervention (intervention arm only)
Study Overview
Brief Summary
This study will examine the feasibility and acceptability of an innovative game-based intervention designed for families of youth aged 11-14 to promote HPV vaccination; will explore changes in key outcomes and related measures; and will identify factors contributing to or impeding effective implementation in health clinic settings. The intervention and its approach have the potential to reduce health disparities in HPV-associated cancers in youth via low-cost technology and timely intervention.
Detailed Description
Guided by Social Cognitive Theory, we propose to
- examine the feasibility and acceptability of a new HPV preventive intervention, the HPV Detective video game, designed for youth and their parents;
- explore pre-post, intervention-related change in vaccine intent and uptake as well as change in theoretically posited intervention mediators; and
- assess the potential for broader intervention implementation. Using a sequential mixed-methods, 2-group (intervention vs usual care), longitudinal design, 64 parent-youth dyads (32/per study condition) will be recruited.
Parent-youth dyads in the intervention will play HPV Detective (tablet format) at the clinic prior to the healthcare provider visits. The control dyads will receive standard clinic treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Youth: (1) 11-14 years old; (2) have not received the 1st dose of HPV vaccine; (3) speak and read English
- •Parent: (1) are the parent/legal guardian of the participating child; (2) ≥ 18 years old; (3) speak English or Spanish; (4) own a smartphone; (5) agree to participate in the research activities at study sites; (6) agree to receive text messages.
- •Healthcare providers: (1) ≥ 20 years old; (2) speak English or Spanish); (3) work at study sites
Exclusion Criteria
- •Individuals are unable to comprehend the consent or assent forms due to cognitive issues
Arms & Interventions
HPV game group
Parent-child dyads receive a HPV game intervention
Intervention: HPV game (Behavioral)
Usual care
Parent-child dyads receive child's usual care
Outcomes
Primary Outcomes
Parent and child acceptability of the intervention (intervention arm only)
Time Frame: 2 years
Assessed by a 12-item Likert scale.
Ease of use (intervention arm only)
Time Frame: 2 years
(1) device-recorded time to complete interactive modules and the full game; (2) self reported easy of use
Percentage of eligible individuals who complete the intervention (intervention arm only) and assessments (all participants)
Time Frame: 2 years
Assessed by the % of eligible individuals who complete the intervention and assessments
Intention to vaccinate the child against HPV
Time Frame: 2 years
Assessed by a Likert scale question: how likely will you (parent) vaccinate your child against HPV? Responses: (1) Very unlikely to (5) Very likely
Percentage of eligible individuals agreeing to participate
Time Frame: 2 years
Assessed by the % of eligible individuals agreeing to participate
Child vaccination status (1st & 2nd doses).
Time Frame: 2 years
Assessed by one binary (yes/no) question regarding whether or not the child has received the 1st \& 2nd dose of HPV vaccine.
Secondary Outcomes
No secondary outcomes reported
Investigators
Angela Chia-Chen Chen
Professor
Michigan State University