Pilot Testing of a Game-Based Intervention to Promote HPV Vaccination in Families With Unvaccinated Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Parent and child acceptability of the intervention (intervention arm only)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Individuals are unable to comprehend the consent or assent forms due to cognitive issues
研究组 & 干预措施
HPV game group
Parent-child dyads receive a HPV game intervention
干预措施: HPV game (Behavioral)
Usual care
Parent-child dyads receive child's usual care
结局指标
主要结局
Parent and child acceptability of the intervention (intervention arm only)
时间窗: 2 years
Assessed by a 12-item Likert scale.
Ease of use (intervention arm only)
时间窗: 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)
时间窗: 2 years
Assessed by the % of eligible individuals who complete the intervention and assessments
Intention to vaccinate the child against HPV
时间窗: 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
时间窗: 2 years
Assessed by the % of eligible individuals agreeing to participate
Child vaccination status (1st & 2nd doses).
时间窗: 2 years
Assessed by one binary (yes/no) question regarding whether or not the child has received the 1st \& 2nd dose of HPV vaccine.
次要结局
未报告次要终点
研究者
Angela Chia-Chen Chen
Professor
Michigan State University