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NCT00862368 · ClinicalTrials.gov registry record · Phase 3

Sustaining Smoking Cessation in Smokers With Kids With Asthma

A Phase 3 study, sponsored by The Miriam Hospital.

Completed
Registry status
Phase 3
Development phase
573
Enrollment target

NCT00862368: Completed Phase 3 study, sponsored by The Miriam Hospital.

NCT00862368 is a Phase 3 study that has completed, run by The Miriam Hospital. The registered enrollment target is 573 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00862368, a Phase 3 study, has completed, sponsored by The Miriam Hospital.

COMPLETED
Registry status
Phase 3
Development phase
573 participants
Enrollment target

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

Primary Outcome

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 readin

Interventions

  • BEHAVIORAL PAM
  • BEHAVIORAL PAM-Enhanced/Asthma Counseling Phone Calls
  • BEHAVIORAL Follow-Up Phone Calls - Child Wellness Topic

Trial Details

FieldValue
Enrollment Target 573 participants
Start Date 2005-10
Est. Completion 2011-12
Phase Phase 3
The Miriam Hospital

136 total trials

What the finished NCT00862368 record still lists

NCT00862368 is an interventional study that assigns participants to a tested intervention. The registered 573 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).

The record links to 0 conditions, and to 3 interventions - of which PAM is the first listed.

NCT00862368 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00862368 about?

NCT00862368 is a clinical study titled "Sustaining Smoking Cessation in Smokers With Kids With Asthma". 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). T...

What is the current status of trial NCT00862368?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 573 participants. The study started on 2005-10. Estimated completion is 2011-12.

What interventions are being tested in trial NCT00862368?

The interventions under investigation include: PAM (BEHAVIORAL), PAM-Enhanced/Asthma Counseling Phone Calls (BEHAVIORAL), Follow-Up Phone Calls - Child Wellness Topic (BEHAVIORAL).

Who is sponsoring clinical trial NCT00862368?

This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00862368's enrollment target sits among peer trials

573 663rd of 2000 higher than 1,338 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00862368, the US trial registry maintained by the National Library of Medicine. NCT00862368 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.