Assessment of Biomarkers in Children to Help Parents Quit Tobacco
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 865
- 试验地点
- 2
- 主要终点
- Parental quit rate
研究概览
简要总结
This randomized controlled trial will test whether adding biomarker measurement and informed outreach for tobacco smoke exposure as part of routine practice increases identification and improves treatment, effectiveness, and sustainability of a parental tobacco control intervention that will be integrated into pediatric practice.
详细描述
This trial will examine the effectiveness of systematic cotinine testing of children 12 years old or younger using blood already collected at any visit to a practice that sees pediatric patients where there is a clinically indicated blood draw. We hypothesize that providing cotinine biomarker results to pediatricians, personalized cotinine feedback to parents about their child's toxin exposure, and offering support to all household tobacco users to quit tobacco use (Biomarker Informed Outreach (BIO)) when added to the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention will increase delivery of tobacco cessation assistance, increase household cessation, reduce tobacco smoke exposure in children, and be cost-effective. This is a 2-arm randomized controlled trial with family-level randomization to either CEASE+BIO or CEASE arms at the time of the child's baseline visit. To compare the effectiveness of CEASE+BIO vs. CEASE, we will follow-up with enrolled parents 12 months later to assess parental quit rate and children's tobacco smoke exposure.
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
- None
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
- •Child 12 years old or younger presenting for a visit.
- •Child scheduled for or has had a clinically indicated blood draw at that visit
- •Parent/legal guardian of the child.
- •Parent/legal guardian is a current smoker (past 7 days).
排除标准
- •Parent/legal guardian is non-English speaking.
- •Parent/legal guardian is less than 18 years of age.
研究组 & 干预措施
CEASE
Those assigned to the Active Comparator arm will receive the CEASE intervention.
干预措施: CEASE (Behavioral)
CEASE + BIO
Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).
干预措施: CEASE (Behavioral)
CEASE + BIO
Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).
干预措施: CEASE + BIO (Behavioral)
结局指标
主要结局
Parental quit rate
时间窗: 12 months
Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed (corrected for NRT use)
Parental quit rate
时间窗: 12 months
Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed (corrected for NRT use)
次要结局
- Self-report parental 7-day point prevalence tobacco abstinence(12 months)
研究者
Jonathan P. Winickoff, MD, MPH
Professor
Massachusetts General Hospital