Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

描述（由申请人提供）：儿童长期二手烟暴露（SHSe）会损害肺功能，并导致呼吸系统疾病、喘息、咳嗽、哮喘、中耳疾病和婴儿猝死综合征。新生儿重症监护室（NICU）收治的早产低出生体重婴儿特别容易受到SHSe的影响，许多婴儿在出院前表现出严重的呼吸或慢性肺部疾病。由于吸烟仍然集中在受教育程度较低和贫困的社区，有家庭吸烟者的新生儿重症监护家庭面临与烟草有关的健康差异的重大风险-这对资源有限的家庭和他们居住的社区来说是一个巨大的负担。本研究的主要目的是评估医院发起的行为干预的有效性，以减少家庭SHSe，与传统的护理实践相比，在低收入，多种族的NICU婴儿的父母在特别高的社会和医疗风险的SHSe的不良影响。将使用随机、对照、平行组设计来测试在医院启动并在家中使用动机性访谈加动机性激励（MI+）完成的SHSe计划是否比NICU父母的常规护理（CC）更有效。MI+与CC对家庭吸烟和婴儿烟雾暴露的影响预计将通过改变动机和治疗参与来介导。将对396个家庭进行随机分组，这些家庭中有一名婴儿在NICU中处于高呼吸风险，并且报告了家庭吸烟者。MI+干预将包括4次一小时的咨询会议（2次在医院; 2次在出院后的家中），以及对参加会议和建立家庭禁烟的激励措施。CC将涉及书面材料，其中包括有关吸烟的影响和戒烟技巧的信息，在与家庭生活协调员的会议上讨论。咨询和面试将以西班牙语和英语进行。主要疗效变量将包括SHSe的客观有效指标（婴儿可替宁、家用空气尼古丁监测器、SHSe的时间轴随访）。将在干预后1个月和6个月使用广义线性混合模型、泊松和逻辑回归评估结局。这将是在NICU背景下针对SHSe的激励策略创新组合的第一项研究，以改善脆弱婴儿及其家人的健康，可能节省数百万美元的医疗保健费用。这一试验也可能表明一种切实可行的方法，使年轻人、少数民族和经济上处于不利地位的家庭获得预防服务，这些家庭不太可能到传统诊所接受这种护理。经验丰富的行为和临床研究人员、表明干预可行性和前景的试点数据、庞大且可访问的人群以及非凡的基础设施确保了研究的成功。

DESCRIPTION (provided by applicant): Chronic secondhand smoke exposure (SHSe) in children compromises pulmonary function and contributes to respiratory illness, wheeze, cough, asthma, middle ear disease, and sudden infant death syndrome. Preterm, low birth weight infants admitted to a Neonatal Intensive Care Unit (NICU) are especially vulnerable to the effects of SHSe, with many exhibiting significant respiratory or chronic lung conditions prior to discharge. Because smoking remains concentrated in less educated and impoverished communities, NICU families with household smokers are at significant risk for tobacco-related health disparities--a substantial burden to families with limited resources and the communities in which they reside. The primary aim of this investigation is to evaluate the efficacy of a hospital initiated, behavioral intervention to reduce household SHSe, compared to conventional care practices, in low-income, multi-ethnic parents of NICU infants at particularly high social and medical risk for adverse effects of SHSe. A randomized, controlled, parallel group design will be used to test whether a SHSe program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC) with NICU parents. The effects of MI+ versus CC on household smoking and infant smoke exposure are expected to be mediated via motivation to change and treatment participation. A total of 396 families with an infant at high respiratory risk in the NICU who report a household smoker will be randomized. The MI+ intervention will consist of 4 one-hour counseling sessions (2 in the hospital; 2 in the home post-discharge) and incentives for both session attendance and establishing a home smoking ban. CC will involve written materials that include information about the effects of smoking and cessation tips discussed in meetings with a Family Life Coordinator. Counseling and interviews will be conducted in Spanish and English. Primary efficacy variables will include objective and valid measures of SHSe (infant cotinine, household air nicotine monitors, Timeline Followback for SHSe). Outcomes will be assessed at 1 and 6 months post-intervention using generalized linear mixed models, poisson and logistic regression. This will be the first study of an innovative combination of motivational strategies targeting SHSe within the context of a NICU to improve the health of vulnerable infants and their families, potentially saving millions in healthcare dollars. This trial may also demonstrate a practical means of accessing young, minority and economically disadvantaged families for preventive services, who are unlikely to present to traditional clinics for such care. Highly experienced behavioral and clinical investigators, pilot data suggesting intervention feasibility and promise, a large and accessible population, and an extraordinary infrastructure ensure study success.