- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01921439
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Other Study ID Numbers
- 3262
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.
Clinical Trials on Tobacco Use Cessation
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Vanderbilt University Medical CenterCompletedTobacco Use | Tobacco Use Cessation
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VirginiaVirginia Foundation for Healthy YouthRecruitingTobacco Use | Electronic Cigarette Use | Tobacco Use CessationUnited States
-
HealthPartners InstituteMinnesota Partnership for Action Against TobaccoCompleted
-
University of California, Los AngelesNYU Langone Health; Olive View-UCLA Education & Research InstituteEnrolling by invitationSmoking Cessation | Tobacco Use CessationUnited States
-
The University of Hong KongFood and Health Bureau, Hong KongCompletedSmoking Cessation | Tobacco Use CessationHong Kong
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Food and Health Bureau, Hong Kong; Queen... and other collaboratorsCompletedSmoking Cessation | Tobacco Use CessationHong Kong
-
Centre for Addiction and Mental HealthCompletedSmoking Cessation | Tobacco Use CessationCanada
Clinical Trials on Personalized Feedback
-
TNOWageningen University and Research; Google LLC.; Jumbo Supermarkten Bv.; Noldus...Completed
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedWeight | Food Choice | Nutrition IntakeUnited States
-
University of HoustonCompletedHeavy DrinkingUnited States
-
Centre for Addiction and Mental HealthCompleted
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedCannabis | Alcohol Consumption | GamblingUnited States
-
Seattle Children's HospitalUnknown
-
Centre for Addiction and Mental HealthCompleted
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of South CarolinaUniversity of Vermont; University of TennesseeCompleted
-
State University of New York at BuffaloCompleted