Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Self-reported 30-day Abstinence
研究概览
简要总结
The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking.
详细描述
Use of electronic nicotine delivery system (ENDS), which are noncombustible tobacco products (e.g., e-cigarettes), has increased dramatically among youth and is associated with numerous adverse health outcomes as well as use of alcohol and other illicit substances. National guidelines recommend counseling to address tobacco use at every adolescent clinical visit; however, many at-risk adolescents do not routinely attend primary care. Although evidence supports treatment of tobacco use during an adult hospitalization, no interventions have been developed or tested in the pediatric hospital setting. Based on promising theoretically-based evidence from the primary care and hospital settings, we will design, iteratively refine and assess implementation of a novel tobacco and ENDS use intervention for hospitalized adolescents and young adults (AYAs). We do so by conducting a randomized controlled pilot study (n=144) with 3-month follow up to evaluate preliminary efficacy as well as implementation outcomes (i.e., acceptability, feasibility, fidelity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Admitted to the hospital
- •Screens positive for past 30 day e-cigarette use
- •Parent/guardian agrees to leave the room
排除标准
- •Age is less than 14 years or over 21 years
- •Not comfortable speaking/reading English
- •Too ill to participate
- •Severe psychiatric illness
- •Too developmentally delayed/cognitively impaired
研究组 & 干预措施
Control
Participants will complete the baseline survey and receive an informational brochure
Intervention
Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey
干预措施: E-cigarette & Tobacco Use Treatment Intervention (Behavioral)
结局指标
主要结局
Self-reported 30-day Abstinence
时间窗: 3 month follow-up
Self reported cessation, assessed at 3 month follow up survey.
Biochemically Verification of Past 30 Day Cessation
时间窗: 3 month follow-up
For participants who self-reported past 30 day cessation, an option was provided to biochemically verify cessation with a mailed saliva sample.
次要结局
- Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program(Study completion (approximately 12 weeks))
- Acceptability of Intervention - Utility of Intervention(Study completion (approximately 12 weeks))
- Feasibility of Intervention - Duration of Intervention(Study completion (approximately 12 weeks))
- Feasibility of Intervention - Intervention Interruptions(Study completion (approximately 12 weeks))
- Feasibility of Intervention - Health Educator Survey(Study completion (approximately 12 weeks))
- Fidelity of Intervention Delivered by a Health Educator(Study completion (approximately 12 weeks))
研究者
Abbey Masonbrink
Pediatric Hospitalist, MD MPH
Children's Hospital Los Angeles