Tobacco dependence counseling in a randomized multisite clinical trial

Area of Science:

• Behavioral Science
• Clinical Psychology
• Public Health

Background:

• Pharmacotherapy trials for tobacco dependence benefit from guideline-consistent behavioral interventions.
• The Smoke Free and Living It© manual offers practical counseling and support.
• This manual was used in a multicenter trial for smokers with attention deficit hyperactivity disorder.

Purpose of the Study:

• To evaluate the performance of the Smoke Free and Living It© manual in a "train-the-trainer" model.
• To assess interventionist skill-adherence and participant intervention-adherence across multiple sites.
• To determine the feasibility of maintaining uniform counseling standards.

Main Methods:

• A multicenter, randomized clinical trial involving 255 smokers with attention deficit hyperactivity disorder.
• Utilized a "train-the-trainer" model with 15 interventionists across 6 sites.
• Analyzed interventionist skill-adherence and participant adherence to the 11-session protocol.

Main Results:

• Participants completed an average of 9.3 sessions, with 61.6% completing all 11 sessions.
• 95.7% of evaluated sessions were rated as adherent to protocol and meeting expectations.
• High fidelity was maintained with minimal supervision, demonstrating effective "train-the-trainer" implementation.

Conclusions:

• The Smoke Free and Living It© manual facilitates high adherence for both interventionists and participants.
• The manual aligns with the United States Public Health Service Clinical Practice Guideline.
• It serves as a valuable, adaptable behavioral intervention option for smoking cessation clinical trials.