OCAST Cessation Study

Study Overview
=================
Brief Summary
-----------------
The long-term goal is to improve the quality of life of children and their parents who smoke tobacco by facilitating parental smoking cessation in a way that is easy to administer yet effective. We aim to accomplish this goal by administering an interactive computer-based program that will facilitate motivation and readiness to engage in smoking cessation by providing personalized feedback about the financial and health effects of the parent's smoking. We will compare the changes in motivation and readiness to quit smoking after the parent has taken the computer-based program and compare them to the changes in motivation and readiness to quit in parents who receive only information about the Oklahoma Tobacco Helpline. We will also measure salivary cotinine levels in both parents and children, to objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis is that our computer-based program will cause a greater increase in motivation and confidence to quit smoking in the group that receives the customized feedback than the group that receives only information about the Tobacco Helpline. We also predict that both parent and child cotinine levels will show a greater decrease in the group randomized to receive personalized feedback.

Official Title
-----------------
Matching Brief Smoking Interventions to Stage of Change

Conditions
-----------------
Tobacco Smoking Behavior, Cigarette Smoking Behavior, Second Hand Tobacco Smoke, Tobacco Use Cessation

Intervention / Treatment
-----------------
* Behavioral: Personalized Feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent or primary caregiver of a child patient at the OU Children's Physicians General Pediatrics clinics Current cigarette user Able to read study forms and verbally communicate with the study staff in English Exclusion Criteria: Nonsmokers Unable to read or speak English well enough to complete the survey and study tasks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Feedback<br>Participants in this group will receive individualized feedback based on their stage of change. Feedback will include health effects of smoking, money spent per month and per year on cigarettes, time spent smoking compared with time spent doing other daily tasks, and how the participant compares to past study participants in average number of cigarettes per day used and level of addiction. | Behavioral: Personalized Feedback<br>* Personalized feedback reflecting the participant's current level of nicotine addiction, money spent on cigarettes, time spent smoking, and health effects of smoking.<br>|
| No Intervention: No Feedback- Treatment as Usual (TAU)<br>Participants will take the computer based survey, but will only receive a number to the Oklahoma Tobacco Helpline (Treatment-as-usual condition) instead of feedback. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Readiness and Motivation to Quit Smoking | We will assess changes in self-reported readiness and motivation to quit smoking. | Baseline, 1-month, 6-months, 12-months | 
| Parent and Child Salivary Cotinine | We will assess change in parent and child salivary cotinine throughout the course of the study. | Baseline, 1-month, 6-months, and 12-months | 
| Change in self-reported cigarette use | We will assess changes in self-reported cigarette use throughout the study. | baseline, 1-month, 6-months, and 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, quit smoking, smoking cessation, smoking study, secondhand smoke, smokers