Sustaining Smoking Cessation in Smokers With Kids With Asthma
PAQS2
Sustaining Cessation in Smokers With Kids With Asthma
2 other identifiers
interventional
573
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Oct 2005
Longer than P75 for phase_3 asthma
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 13, 2009
CompletedFirst Posted
Study publicly available on registry
March 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 25, 2012
April 1, 2012
6.2 years
March 13, 2009
April 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking Status
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.
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.
Secondary Outcomes (3)
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.
Study Arms (3)
PAM -Enhanced/Asthma
EXPERIMENTALThe 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.
PAM-Asthma
ACTIVE COMPARATORThe 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.
PAM-Healthy
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Miriam Hospitallead
- Brown Universitycollaborator
- University of California, Berkeleycollaborator
- RTI Internationalcollaborator
- Rhode Island Hospitalcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (5)
St. Anne's Hospital
Fall River, Massachusetts, 02721, United States
Memorial Hospital of RI
Pawtucket, Rhode Island, 02860, United States
Hasbro Children's Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Kent County Hospital
Warwick, Rhode Island, 02886, United States
Related Publications (2)
Wagener TL, Gregor KL, Busch AM, McQuaid EL, Borrelli B. Risk perception in smokers with children with asthma. J Consult Clin Psychol. 2010 Dec;78(6):980-5. doi: 10.1037/a0021094.
PMID: 21114346BACKGROUNDBorrelli B, McQuaid EL, Tooley EM, Busch AM, Hammond SK, Becker B, Dunsiger S. Motivating parents of kids with asthma to quit smoking: the effect of the teachable moment and increasing intervention intensity using a longitudinal randomized trial design. Addiction. 2016 Sep;111(9):1646-55. doi: 10.1111/add.13389. Epub 2016 May 17.
PMID: 27184343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Belinda Borrelli, PhD
Brown University/The Miriam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry and Human Behavior
Study Record Dates
First Submitted
March 13, 2009
First Posted
March 16, 2009
Study Start
October 1, 2005
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
April 25, 2012
Record last verified: 2012-04