Sustaining Smoking Cessation in Smokers With Kids With Asthma (PAQS2)
This study has been completed.
Sponsor:
The Miriam Hospital
Collaborators:
Brown University
University of California, Berkeley
RTI International
Rhode Island Hospital
Information provided by (Responsible Party):
Belinda Borrelli, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00862368
First received: March 13, 2009
Last updated: April 24, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Smoking Cessation |
Behavioral: PAM Behavioral: PAM-Enhanced/Asthma Counseling Phone Calls Behavioral: Follow-Up Phone Calls - Child Wellness Topic |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sustaining Cessation in Smokers With Kids With Asthma |
Resource links provided by NLM:
Further study details as provided by The Miriam Hospital:
Primary Outcome Measures:
- Smoking Status [ Time Frame: 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. ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Environmental Tobacco Smoke, Self-Report [ Time Frame: 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. ] [ Designated as safety issue: No ]A self-report questionnaire (Matt, Hovell et al., 2000) was administered using a structured interview designed to elicit reliable memory-based reports of the participant's own smoking rate as well as their report of others' smoking rates while in the home. The interview contains questions that assess the total, average, least, and greatest number of cigarettes smoked in the home, in the car and away from home. Another questionnaire, The Environmental Tobacco Smoke Survey, assessed whether or not participants' had smoking bans in their home and car, and their readiness to implement these bans.
- Environmental Tobacco Smoke: Air Samplers [ Time Frame: 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. ] [ Designated as safety issue: No ]ETS was objectively measured with passive nicotine air samplers that utilize nicotine as a tracer for ETS. Samplers use a filter treated with sodium bisulfate (weak acid) which reacts with nicotine(a weak base) to form a stable salt. The filter is contained in a 4 cm polystyrene cassette, which has a membrane filter as a windscreen. For each participant, one sampler was placed in the room in which the child spends the most time and one was worn by the child (at baseline and at after the 5th follow-up phone call for 7 days each). Samplers were analyzed by Co-I Hammond.
- Asthma Morbidity [ Time Frame: 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. ] [ Designated as safety issue: No ]Functional morbidity due to asthma was measured using the Asthma Assessment Form, adapted from the Functional Severity scale by Rosier et al. (1994). Questions assess the child's asthma symptoms over the past month, and assess how asthma has impacted limitations in general activity, school attendance, and sports participation for school-aged children. Questions about frequency of doctor visits, emergency room visits, hospitalizations, and medication use (including rescue inhaler, nebulizer, and steroid use) are also included.
| Enrollment: | 573 |
| Study Start Date: | October 2005 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PAM -Enhanced/Asthma
The PAM-Enhanced/Asthma group: 2 in-home visits that included asthma education consistent with NIH recommendations (NIH, NAEPP, 1997) and smoking cessation counseling. Consistent with Motivational Interviewing (MI), smoking was broached in a non-judgmental manner and as another trigger for asthma. Feedback was given on expired air Carbon Monoxide (CO) levels of the smoker (to increase personal perception of risk) and the amount of smoke exposure to the child (to increase risk perception to the child). 6 phone calls were then provided over the next 4 months that focused on asthma education, a second round of feedback on the child's ETS exposure, and smoking cessation counseling. MI was used at all contacts. Free nicotine patch tx was given if they were ready to quit within 30 days.
|
Behavioral: PAM
Visit 1 included asthma education (or child wellness for healthy children), expired air carbon monoxide feedback, Motivational Interviewing, and techniques to accelerate the participants readiness to quit. Visit 2 included a follow up on the child's asthma (PAM and PAM-Enhanced only), assessing the smoker's motivation to quit, feedback on CO readings and air sampler results (smoke exposure to the child), risks of smoking, and benefits of quitting. Counselors employed Motivational Interviewing techniques. Free nicotine patch tx was given if they were ready to quit within 30 days.
Other Names:
Behavioral: PAM-Enhanced/Asthma Counseling Phone Calls
PAM-Enhanced/Asthma counseling calls were made over the 4 months following in-home counseling and focused on: 1) checking in on the child's asthma, 2) motivating quit attempts, and 3) preventing relapse among quitters. The final phone call (#6) included feedback on the 2nd set of air samplers placed in the home and with the child after phone call 5. Only the PAM-Enhanced/Asthma condition received this 2nd round of ETS feedback. A printed feedback report was provided to participants. If still smoking, counseling focused on ETS reduction and motivation to change. If quit, counseling focused on reinforcement of successful behavior change and motivation to stay quit. Motivational Interviewing techniques were used. Free nicotine patch tx was given if they were ready to quit within 30 days.
Other Names:
|
|
Active Comparator: PAM-Asthma
The PAM-Asthma arm received the same in-home counseling visits as PAM-Enhanced/Asthma. The 6 counseling phone calls were different from those received by PAM-Enhanced/Asthma, and included only an asthma follow-up and discussion of a child wellness topic. Smoking cessation was not discussed and additional feedback on ETS samplers was not provided. Motivational Interviewing approaches were used in all in-home and phone counseling. Free nicotine patch tx was given if they were ready to quit within 30 days.
|
Behavioral: PAM
Visit 1 included asthma education (or child wellness for healthy children), expired air carbon monoxide feedback, Motivational Interviewing, and techniques to accelerate the participants readiness to quit. Visit 2 included a follow up on the child's asthma (PAM and PAM-Enhanced only), assessing the smoker's motivation to quit, feedback on CO readings and air sampler results (smoke exposure to the child), risks of smoking, and benefits of quitting. Counselors employed Motivational Interviewing techniques. Free nicotine patch tx was given if they were ready to quit within 30 days.
Other Names:
|
|
Active Comparator: PAM-Healthy
The PAM-Healthy arm received the same in-home counseling visits as PAM and PAM Enhanced but asthma information was replaced with child wellness topics. The 6 counseling phone calls were the same timing and duration as the other two groups (six, 15 minutes calls, over four months) focused on a child wellness topic. Smoking cessation or sampler feedback was not discussed. Motivational Interviewing approaches were used in all in-home and phone counseling. Free nicotine patch tx was given if they were ready to quit within 30 days.
|
Behavioral: PAM
Visit 1 included asthma education (or child wellness for healthy children), expired air carbon monoxide feedback, Motivational Interviewing, and techniques to accelerate the participants readiness to quit. Visit 2 included a follow up on the child's asthma (PAM and PAM-Enhanced only), assessing the smoker's motivation to quit, feedback on CO readings and air sampler results (smoke exposure to the child), risks of smoking, and benefits of quitting. Counselors employed Motivational Interviewing techniques. Free nicotine patch tx was given if they were ready to quit within 30 days.
Other Names:
Behavioral: Follow-Up Phone Calls - Child Wellness Topic
Over the 4 months following in-home counseling visits, subjects in the PAM-Asthma and PAM-Healthy conditions received 6 phone calls that included an asthma check-in (PAM-Asthma only) and discussion of a child wellness topic. Counselors employed Motivational Interviewing techniques. Free nicotine patch tx was given if they were ready to quit within 30 days.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria: 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)
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862368
Locations
| United States, Massachusetts | |
| St. Anne's Hospital | |
| Fall River, Massachusetts, United States, 02721 | |
| United States, Rhode Island | |
| Memorial Hospital of RI | |
| Pawtucket, Rhode Island, United States, 02860 | |
| The Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| Hasbro Children's Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Kent County Hospital | |
| Warwick, Rhode Island, United States, 02886 | |
Sponsors and Collaborators
The Miriam Hospital
Brown University
University of California, Berkeley
RTI International
Rhode Island Hospital
Investigators
| Principal Investigator: | Belinda Borrelli, PhD | Brown University/The Miriam Hospital |
More Information
Publications:
| Responsible Party: | Belinda Borrelli, Professor of Psychiatry and Human Behavior, The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT00862368 History of Changes |
| Other Study ID Numbers: | R01 HL 062165 - 09, R01HL062165 |
| Study First Received: | March 13, 2009 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Miriam Hospital:
|
Motivational Interviewing Pediatric Asthma Smoking Cessation Environmental Tobacco Smoke Second hand smoke Biomarker Asthma |
Asthma Education Family Intervention Smoking Nicotine Patch Parents Caregivers Child Wellness |
Additional relevant MeSH terms:
|
Asthma Smoking Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Habits |
Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013