Sustaining Smoking Cessation in Smokers With Kids With Asthma

NCT00862368 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 573

Last updated 2012-04-25

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Brown University

    collaborator OTHER
  • University of California, Berkeley

    collaborator OTHER
  • RTI International

    collaborator OTHER
  • Rhode Island Hospital

    collaborator OTHER
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Belinda Borrelli, PhD · Brown University/The Miriam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00862368 on ClinicalTrials.gov