Sustaining Cessation in Smokers With Kids With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 573
- 试验地点
- 10
- 主要终点
- Smoking Status
研究概览
简要总结
Parents of Asthmatics Quit Smoking (PAQS-2) is a randomized controlled trial of a smoking cessation intervention for parents who smoke. Children had either a diagnosis of asthma (and an asthma emergency within the past 3 months) or were healthy (and had no medical conditions in the past 3 months). The study intervention aimed to help parents (or caregivers) quit smoking and reduce children's second hand smoke exposure. Participants received 2 home counseling sessions with asthma education (if they had a child with asthma), child wellness (if they had a healthy child) and smoking cessation counseling (including objective feedback on how much smoke the child was exposed to). Parents of children with asthma were then randomized into 2 groups; one group received 6 counseling phone calls focused on motivating smoking cessation and a second round of feedback on smoke exposure (Enhanced). The other groups received six calls focused on asthma (PAM asthma group) or child wellness (Healthy group). We had 2 primary aims. First, to explore the "teachable moment" we compared quit rates between the parents of children with asthma to the parents of healthy children. We hypothesized that the Asthma group would have significantly greater quit rates than the Healthy group and lower levels of environmental tobacco smoke in the home. We also hypothesized that parents who smoke and have children with asthma would have greater changes in the variables associated with teachable moment compared to parents who smoke and have a healthy child. --- The second primary aim focused on the parents of children with asthma. We assessed the effectiveness of adding telephone smoking cessation counseling to the 2 home counseling visits. For this, we compared the 2 groups of randomized subjects: those who received 6 counseling calls and feedback on smoke exposure (PAM-Enhanced) and those who received 6 counseling calls focused on asthma education (PAM-Asthma). We hypothesized that the PAM-Enhanced group would have significantly greater quit rates than the PAM-Asthma group, lower likelihood of smoking relapse, and lower levels of environmental tobacco smoke in the home. We also explored the hypothesized role of precaution effectiveness (i.e. quitting smoking will be associated with benefits for self and child) and self-efficacy for quitting as mediators of the effectiveness of PAM-Enhanced/Asthma. A third aim was to compare asthma symptoms over time between the two groups.
详细描述
Asthma is one of the most common pediatric diseases affecting 6.7 million children and adolescents (Akinbami et al 2009). Asthma is a leading cause of hospitalizations, emergency department visits, school absences, and activity restriction for youth (ALA, 2011; Taylor et al., 1992; Weiss et al., 1992). Smoking is the leading cause of preventable morbidity and mortality as 443,000 deaths are attributable to smoking each year (CDC, 2012).
This study had two aims that built on the results of a previous study (Borrelli et al., 2002): 1) to characterize the cognitive, affective, and behavioral changes associated with the Teachable Moment (TM), and 2) to test whether or not an extended intervention augments quit rates and prevents relapse over and above a previous theory-based smoking cessation intervention for low-income caregivers of children with asthma (Borrelli et al., 2002).
In our study, we viewed the provision of objectivefeedback about the child's exposure to ETS as necessary to link the caregiver's smoking with the child's asthma. It was hypothesized that providing feedback within the context of heightened awareness of the child's health constitutes the teachable moment. The first aim of this study was to examine, in two populations, the effect of an intervention based on The Precaution Adoption Model (PAM) (Weinstein, 1988), in which Motivational Interviewing and biomarker feedback (smoker's CO level and child's ETS exposure) were used to increase risk perception to self and child. Our populations were: 1) smokers whose child with asthma had an acute exacerbation (PAM-Asthma) and 2) smokers who had a healthy child (PAM-Healthy).
The second aim was to test the effect of increasing the intensity of our original theory-based intervention, PAM, by adding telephone counseling that focuses on motivating and sustaining quit attempts. Though our previous study demonstrated excellent quit rates in the short term (at 2 month follow-up), there was a dramatic decrease in abstinence by 6 months. Therefore, caregivers of kids with asthma were randomized to either 1) PAM-Asthma: our original intervention plus six contact control calls focusing on the child's asthma and child wellness (diet, exercise, safety, etc.) or 2) PAM-Enhanced/Asthma: our original intervention plus six counseling calls that focus on the child's asthma, motivating quit attempts, and preventing relapse. Precaution effectiveness (belief that quitting will improve one's own and the child's health) and self-efficacy were the primary intervention targets during the PAM-Enhanced/Asthma calls.
A. Primary Aims
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
- Double (Participant, Outcomes Assessor)
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
- •In order to be included in the study, participants had to:
- •be caregivers for a child (defined as having the child in the home for at least 4 hours per week) between the ages of 3 and 17,
- •be current, regular smokers (at least 3 cigarettes per day for the past year)
- •be over age 18
- •speak and understand English
- •have a telephone
- •agree to participate in all phases of the study
- •have a child with a diagnosis of asthma (asthma groups only)
排除标准
- •if the index child had asthma, child DID NOT have a urgent care/emergency room/hospital visit within 90 days of the first intervention visit
- •if the index child was healthy, child DID have a urgent care/emergency room/hospital visit within 90 days of the first intervention visit and had no diagnosis of asthma (or other children in the home with asthma)
- •had children with other significant pulmonary disease
- •the index child spent less than 4 hours in the home per week
- •caregiver exclusively used another form of tobacco (not cigarettes)
- •using any form of Nicotine replacement therapy
- •using medications to quit smoking
- •in a quit smoking program
- •another member of family is participating in program
- •currently pregnant or planning to become pregnant
- •While we did offer the intervention to all smokers in the home, only the caregiver that spent the most time with the child was included in the formal study.
结局指标
主要结局
Smoking Status
时间窗: 2 months after the end of home visits; after the end of the phone calls (4 months). The 6 month follow-up occurred approximately 2 months after the four month assessment and the 12 month assessment occurred 6 months after the 6 month assessment.
Smoking Status was assessed at all follow-up assessments. Seven-day point prevalence abstinence (no smoking at all in the previous seven days, not even a puff) and 30 day point-prevalence abstinence (no smoking at all in the previous 30 days, not even a puff) were used as dependent variables. CO Verification: Those participants who reported a smoking status of "Quit" at follow-up assessments were tested for carbon monoxide levels using a exhaled breath analyzer. Those with Carbon Monoxide readings \<=10 ppm were considered abstinent.
次要结局
- Environmental Tobacco Smoke, Self-Report(Baseline, and 2 mos after the end of home visits; after the end of phone calls (4 mos). The 6 month follow-up was approximately 2 months after the 4 month assessment and the 12 month assessment occurred 6 mos after the 6 month assessment.)
- Environmental Tobacco Smoke: Air Samplers(Placed at baseline and collected after 7 days of exposure; Placed after phone call 5 (approximately 3.5 months after Intervention Visit 2) and collected after 7 days exposure.)
- Asthma Morbidity(Baseline and 2 mos after the end of home visits; after the end of phone calls (4 mos). The 6 month follow-up was approximately 2 months after the 4 month assessment and the 12 month assessment occurred 6 mos after the 6 month assessment.)
研究者
Belinda Borrelli
Professor of Psychiatry and Human Behavior
The Miriam Hospital