Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-02 @ 9:49 AM
Study NCT ID:
NCT00862368
Status:
COMPLETED
Last Update Posted:
2012-04-25
First Post:
2009-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustaining Smoking Cessation in Smokers With Kids With Asthma
Sponsor:
The Miriam Hospital
Organization:
Study Overview
Official Title:
Sustaining Cessation in Smokers With Kids With Asthma
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAQS2
Brief Summary:
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.
Detailed Description:
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
Aim 1: To assess the cognitive, affective, and behavioral changes involved in the "teachable moment" by examining those who receive PAM and have children with asthma (PAM-Asthma) vs. those who receive PAM and have healthy children (PAM-Healthy).
Hypothesis 1.1: PAM-Asthma will, at follow-ups, have significantly greater quit rates than PAM-Healthy (7-day point prevalence abstinence, 30 day abstinence) and lower levels of ETS in the home.
Hypothesis 1.2: Parents who smoke and have children with asthma (PAM-Asthma) will have greater changes in the variables hypothesized to be associated with teachable moment (perceived risk, affect, self-concept) vs. parents who smoke and have a healthy child (PAM-Healthy). We are also exploring the mediational role of these factors on outcome.
Aim 2: Among the parents of children with asthma, to assess the effectiveness adding telephone counseling to our previously tested intervention, PAM, (PAM-Enhanced/Asthma) vs. PAM plus contact control (PAM-Asthma).
Hypothesis 2.1. PAM-Enhanced/Asthma will, at follow-ups, have significantly greater quit rates than PAM-Asthma (7 day point prevalence abstinence, 30 day abstinence), lower likelihood of relapse, and lower levels of ETS in the home.
Hypothesis 2.2. Explore 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). We also plan to explore the effect of important moderating variables (demographics, social support, depressed mood) on smoking outcomes.
B. Secondary Aims:
Aim 3: To assess differences between PAM-Enhanced/Asthma and PAM-Asthma groups in asthma morbidity and health care utilization among children with asthma.
Hypothesis 3.1: PAM-Enhanced/Asthma will have lower levels of functional morbidity due to asthma (i.e., fewer symptoms and less activity limitations) vs. PAM-Asthma.
Hypothesis 3.2: PAM-Enhanced/Asthma will have lower levels of health care utilization including fewer hospital days for asthma, fewer urgent care visits for asthma, and fewer prescription refills for quick-relief asthma medications vs. PAM-Asthma.
C. Study Design
This was a three group design with 2 group comparisons. In order to test Aim 1 (Teachable Moment) smokers with kids with asthma (PAM-Asthma) were compared to smokers with healthy kids (PAM-Healthy) on their cognitive, affective, and behavioral changes before and immediately after receiving feedback on the child's smoke exposure. Both groups received home-based smoking cessation counseling (PAM), and six contact control calls focused on child wellness or asthma education. In order to test Aim 2, improving and sustaining the smoking cessation rates, smokers with kids with asthma were randomly assigned to receive to either PAM + six contact control calls (PAM-Asthma) or PAM + six counseling calls that focused on building precaution effectiveness and self-efficacy (PAM-Enhanced).
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
Aim 1: To assess the cognitive, affective, and behavioral changes involved in the "teachable moment" by examining those who receive PAM and have children with asthma (PAM-Asthma) vs. those who receive PAM and have healthy children (PAM-Healthy).
Hypothesis 1.1: PAM-Asthma will, at follow-ups, have significantly greater quit rates than PAM-Healthy (7-day point prevalence abstinence, 30 day abstinence) and lower levels of ETS in the home.
Hypothesis 1.2: Parents who smoke and have children with asthma (PAM-Asthma) will have greater changes in the variables hypothesized to be associated with teachable moment (perceived risk, affect, self-concept) vs. parents who smoke and have a healthy child (PAM-Healthy). We are also exploring the mediational role of these factors on outcome.
Aim 2: Among the parents of children with asthma, to assess the effectiveness adding telephone counseling to our previously tested intervention, PAM, (PAM-Enhanced/Asthma) vs. PAM plus contact control (PAM-Asthma).
Hypothesis 2.1. PAM-Enhanced/Asthma will, at follow-ups, have significantly greater quit rates than PAM-Asthma (7 day point prevalence abstinence, 30 day abstinence), lower likelihood of relapse, and lower levels of ETS in the home.
Hypothesis 2.2. Explore 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). We also plan to explore the effect of important moderating variables (demographics, social support, depressed mood) on smoking outcomes.
B. Secondary Aims:
Aim 3: To assess differences between PAM-Enhanced/Asthma and PAM-Asthma groups in asthma morbidity and health care utilization among children with asthma.
Hypothesis 3.1: PAM-Enhanced/Asthma will have lower levels of functional morbidity due to asthma (i.e., fewer symptoms and less activity limitations) vs. PAM-Asthma.
Hypothesis 3.2: PAM-Enhanced/Asthma will have lower levels of health care utilization including fewer hospital days for asthma, fewer urgent care visits for asthma, and fewer prescription refills for quick-relief asthma medications vs. PAM-Asthma.
C. Study Design
This was a three group design with 2 group comparisons. In order to test Aim 1 (Teachable Moment) smokers with kids with asthma (PAM-Asthma) were compared to smokers with healthy kids (PAM-Healthy) on their cognitive, affective, and behavioral changes before and immediately after receiving feedback on the child's smoke exposure. Both groups received home-based smoking cessation counseling (PAM), and six contact control calls focused on child wellness or asthma education. In order to test Aim 2, improving and sustaining the smoking cessation rates, smokers with kids with asthma were randomly assigned to receive to either PAM + six contact control calls (PAM-Asthma) or PAM + six counseling calls that focused on building precaution effectiveness and self-efficacy (PAM-Enhanced).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL062165 | NIH | None | https://reporter.nih.gov/quic… | View |