OCAST Cessation Study (OCAST)

April 7, 2017 updated by: University of Oklahoma

Matching Brief Smoking Interventions to Stage of Change

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Tobacco Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Feedback
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.
Personalized feedback reflecting the participant's current level of nicotine addiction, money spent on cigarettes, time spent smoking, and health effects of smoking.
No Intervention: No Feedback- Treatment as Usual (TAU)
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
Time Frame: Baseline, 1-month, 6-months, 12-months
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
Time Frame: Baseline, 1-month, 6-months, and 12-months
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
Time Frame: baseline, 1-month, 6-months, and 12-months
We will assess changes in self-reported cigarette use throughout the study.
baseline, 1-month, 6-months, and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stephen Gillaspy, Ph.D., The University of Oklahoma Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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