CONFIDENCE: A Pilot Randomized Control Trial With Waitlist Condition to Test a Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 667
- 试验地点
- 2
- 主要终点
- COVID-19 vaccine intention
研究概览
简要总结
The goal of this study is to refine and test CONFIDENCE, a multi-component clinic-based intervention in pediatric or family practice clinical settings. Using a randomized control trial design, the investigators will assess preliminary effectiveness of the intervention to increase COVID-19 vaccine intention among parents of under-vaccinated children ages 5 to 17.
Participating clinics will receive a brief intervention consisting of: (1) webinar training focused on communication with vaccine-hesitant parents, (2) parent-facing educational materials about COVID-19 vaccination, (3) support to create a personalized, poster campaign featuring providers. Clinics in the control condition will receive the intervention approximately 12 months after the clinics in the intervention condition.
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 (Participant)
盲法说明
Clinics will know if they are assigned to the intervention or control condition. However, individual participants (parents of children ages 5 to 17) will not know if their clinic is in the intervention or control condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Practice site inclusion criteria
- •Pediatric or family practice clinic that serves pediatric population (ages 5 to 17)
- •Affiliated with UMass Memorial Health Care and/or Baystate Health
- •Serve a patient population that is at least 30% racial/ethnic minority group members.
- •Inclusion Criteria for Parents:
- •The following inclusion criteria will be applied to parents (on behalf of their children):
- •Parent/guardian (referred to as parents in this proposal) of child between ages 5 and 17
- •Able to read and write in English, Spanish, Portuguese or Vietnamese, which are the predominant languages in the target communities
- •Parent of patient at participating clinical site/child received non-urgent care visit during study period
- •Child not up-to-date for COVID-19 per current CDC guidelines at the time of enrollment.
排除标准
- •for Parents:
- •°Parent under age of 18
结局指标
主要结局
COVID-19 vaccine intention
时间窗: Data collection will occur in the four weeks following implementation
Parent exit survey in clinics: Parents will report their intention to vaccinate their children for COVID-19. See survey question below: "Did you decide to vaccinate your child against COVID-19 today? Yes/No"
次要结局
- Feasibility: Randomization(End of study; approximately 15 months)
- Perceived feasibility: Providers and clinic staff(Four to eight weeks post implementation)
- Feasibility: Recruitment(End of study; approximately 15 months)
- Implementation Fidelity(Four to eight weeks post implementation)
- Acceptability: Providers and clinic staff(Four to eight weeks post implementation)
- Perceived Appropriateness: Providers and clinic staff(Four to eight weeks post implementation)
- Perceived appropriateness: Parents(Four to eight weeks post implementation)
- Feasibility: Data Completeness(End of study; approximately 15 months)
- Acceptability: Parents(Four to eight weeks post implementation)
研究者
Stephenie Lemon
Professor and Chief of the Division of Preventive and Behavioral Medicine, Department of Population and Quantitative Health Sciences
University of Massachusetts, Worcester