Kids Safe and Smokefree (KiSS) (KiSS)
2018年7月10日 更新者：Temple University
Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
The study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (CQI+A).
A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.
研究概览
地位
完全的
详细说明
Child secondhand smoke exposure (SHSe) is a significant public health problem that has been linked to asthma, acute respiratory illnesses, otitis, and SIDS, and is associated with increased risk of cancers, cardiovascular disease, and behavior problems.
This project will test the effectiveness of a comprehensive multilevel intervention to reduce young children's SHSe in minority and medically underserved communities known to have the highest SHSe-related morbidity and mortality risk.
First, we will provide a clinic-level quality improvement (CQI) intervention to improve the care of pediatric patients with SHSe in four pediatric clinics in North and West Philadelphia.
We will then randomize eligible parents visiting the CQI clinics into either a home-level behavioral counseling intervention (CQI+BC) or a home-level attention control intervention (CQI+A).
In addition to clinic-level intervention, CQI+BC provides personalized, behavioral counseling with intensive skills training and support where SHSe occurs (in the home), as well as systems navigation to facilitate access to and effective use of reimbursable nicotine replacement therapy and smoking cessation medication.
Participants will complete assessments at pre-treatment, 3-month end of treatment, and 12-month follow-up.
研究类型
介入性
注册 (实际的)
327
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19122
- Temple University
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Philadelphia、Pennsylvania、美国、19134
- St. Christopher's Hospital for Children
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Philadelphia、Pennsylvania、美国、19104
- Children's Hospital of Philadephia
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Philadelphia、Pennsylvania、美国、19140
- Temple University Hospital System
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- at least 18 years of age
- English-speaking
- parent or legal guardian of child under 11 years old who lives with him/her
- daily smoker
Exclusion Criteria:
- non-nicotine drug dependence
- psychiatric disturbance (bipolar, schizophrenia, psychosis)
- pregnant
- inadequate health literacy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Clinic Quality Improvement + Behavioral Counseling
This multilevel intervention includes advice and a referral from a pediatrician, behavioral counseling by study staff, and community systems navigation, all designed to reduce pediatric secondhand smoke exposure.
Over the course of 12 weeks participants receive a home visit designed to orient them to the program and trained health counselors provide multiple individualized phone counseling sessions designed to build coping skills, urge management skills, and self-efficacy.
Counseling also includes assistance with goal setting and navigation of local resources.
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有源比较器：Clinic Quality Improvement + Attention Control
The attention control intervention parallels the format of the experimental group but focuses on family nutrition information.
The intervention includes a home visit to orient the participant to the program and multiple phone counseling sessions conducted by a trained health counselor.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Child Urine Cotinine
大体时间：up to 12 months
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Child urine cotinine is a biomarker for assessing second-hand smoke exposure.
We anticipate the CQI+BC treatment group will experience a greater reduction in child urine cotinine over time than the CQI+A control group.
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up to 12 months
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Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources
大体时间：up to 12 months
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Parental report of cigarettes child is exposed to each day in the home and car by all sources during the 7 days prior to assessment.
We anticipate the CQI+BC treatment group will report greater reductions in second-hand smoke exposure over time than the CQI+A control group.
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up to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
大体时间：up to 12 months
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When a participant reports smoking abstinence, we will bioverify their smoking status.
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up to 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Brad Collins, PhD、Temple University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lepore SJ, Winickoff JP, Moughan B, Bryant-Stephens TC, Taylor DR, Fleece D, Davey A, Nair US, Godfrey M, Collins BN. Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children. BMC Public Health. 2013 Aug 30;13:792. doi: 10.1186/1471-2458-13-792.
- Collins BN, Lepore SJ, Winickoff JP, Nair US, Moughan B, Bryant-Stephens T, Davey A, Taylor D, Fleece D, Godfrey M. An Office-Initiated Multilevel Intervention for Tobacco Smoke Exposure: A Randomized Trial. Pediatrics. 2018 Jan;141(Suppl 1):S75-S86. doi: 10.1542/peds.2017-1026K. Erratum In: Pediatrics. 2018 Jun;141(6):
- Collins BN, Lepore SJ, Winickoff JP, Sosnowski DW. Parents' Self-efficacy for Tobacco Exposure Protection and Smoking Abstinence Mediate Treatment Effects on Child Cotinine at 12-Month Follow-up: Mediation Results from the Kids Safe and Smokefree Trial. Nicotine Tob Res. 2020 Oct 29;22(11):1981-1988. doi: 10.1093/ntr/ntz175.
- Lepore SJ, Collins BN, Sosnowski DW. Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention. Drug Alcohol Depend. 2019 Nov 1;204:107496. doi: 10.1016/j.drugalcdep.2019.05.027. Epub 2019 Aug 24.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年3月1日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2012年11月12日
首先提交符合 QC 标准的
2012年12月7日
首次发布 (估计)
2012年12月10日
研究记录更新
最后更新发布 (实际的)
2018年8月8日
上次提交的符合 QC 标准的更新
2018年7月10日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.