Ignite Creation Date:
2024-05-05 @ 9:21 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00862368
Status:
COMPLETED
Last Update Posted:
2012-04-25
First Post:
2009-03-13
Brief Title:
Sustaining Smoking Cessation in Smokers With Kids With Asthma
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
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 childrens 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 ie quitting smoking will be associated with benefits for self and child and self-efficacy for quitting as mediators of the effectiveness of PAM-EnhancedAsthma 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 67 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 443000 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 childs exposure to ETS as necessary to link the caregivers smoking with the childs asthma It was hypothesized that providing feedback within the context of heightened awareness of the childs 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 smokers CO level and childs 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 childs asthma and child wellness diet exercise safety etc or 2 PAM-EnhancedAsthma our original intervention plus six counseling calls that focus on the childs asthma motivating quit attempts and preventing relapse Precaution effectiveness belief that quitting will improve ones own and the childs health and self-efficacy were the primary intervention targets during the PAM-EnhancedAsthma 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 11 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 12 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-EnhancedAsthma vs PAM plus contact control PAM-Asthma
Hypothesis 21 PAM-EnhancedAsthma 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 22 Explore the hypothesized role of precaution effectiveness ie quitting smoking will be associated with benefits for self and child and self-efficacy for quitting as mediators of the effectiveness of PAM-EnhancedAsthma 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-EnhancedAsthma and PAM-Asthma groups in asthma morbidity and health care utilization among children with asthma
Hypothesis 31 PAM-EnhancedAsthma will have lower levels of functional morbidity due to asthma ie fewer symptoms and less activity limitations vs PAM-Asthma
Hypothesis 32 PAM-EnhancedAsthma 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 childs 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 childs exposure to ETS as necessary to link the caregivers smoking with the childs asthma It was hypothesized that providing feedback within the context of heightened awareness of the childs 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 smokers CO level and childs 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 childs asthma and child wellness diet exercise safety etc or 2 PAM-EnhancedAsthma our original intervention plus six counseling calls that focus on the childs asthma motivating quit attempts and preventing relapse Precaution effectiveness belief that quitting will improve ones own and the childs health and self-efficacy were the primary intervention targets during the PAM-EnhancedAsthma 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 11 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 12 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-EnhancedAsthma vs PAM plus contact control PAM-Asthma
Hypothesis 21 PAM-EnhancedAsthma 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 22 Explore the hypothesized role of precaution effectiveness ie quitting smoking will be associated with benefits for self and child and self-efficacy for quitting as mediators of the effectiveness of PAM-EnhancedAsthma 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-EnhancedAsthma and PAM-Asthma groups in asthma morbidity and health care utilization among children with asthma
Hypothesis 31 PAM-EnhancedAsthma will have lower levels of functional morbidity due to asthma ie fewer symptoms and less activity limitations vs PAM-Asthma
Hypothesis 32 PAM-EnhancedAsthma 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 childs 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL062165 | NIH | None | httpsreporternihgovquickSearchR01HL062165 |