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Sustaining Cessation in Smokers With Kids With Asthma

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Trial Conditions
  • Asthma
  • Smoking Cessation
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Belinda Borrelli, PhD
Facilities
  • Saint Anne's Hospital - Completed
Trial Interventions
Behavioral
  • PAM
  • PAM-Enhanced/Asthma Counseling Phone Calls
  • Follow-Up Phone Calls - Child Wellness Topic
Physician Researcher

Investigator Name:

  • Belinda Borrelli, PhD

Other Information

Sponsor: The Miriam Hospital
Phase: Phase 3
Trial ID: NCT00862368
Volunteers:  Accepting Healthy Volunteers

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