- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01326234
Computer-Based Program to Facilitate Readiness and Motivation for Smoking Cessation
April 18, 2017 updated by: Stephen Gillaspy, University of Oklahoma
Further Development and Testing of an Interactive Computer-Based Program to Facilitate Readiness and Motivation for Smoking Cessation
The current study seeks to use a computer-based program to target parents of children who smoke.
Parents will be randomly assigned to either receive personalized feedback about their smoking behaviors or not.
One month after gathering their baseline information, all participants will be asked to complete follow-up questionnaires online assessing their smoking behaviors.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Tobacco use is widely recognized as the most preventable cause of cancer in the United States.
Furthermore, tobacco use is responsible for 30% of all cancer-related deaths in the United States.
Although practice guidelines recommend that clinicians address tobacco use during all outpatient clinic visits, the realities of the clinic setting make this difficult for overworked and overstretched clinical personnel.
A computer-based intervention may enhance patient care by decreasing this burden and priming patients and families for a discussion about smoking cessation with their physician.
Previous research has demonstrated the feasibility of developing and implementing an interactive computer-based program to facilitate smoking cessation in the outpatient clinic setting.
The program can be self-administered, presents minimal burden to existing staff, and meets the Public Health Service practice guidelines.
Furthermore, this intervention was found to be effective at increasing readiness to change in parental smoking behavior.
The overall objective of this proposal is to further develop the program and test this interactive computer-based program to facilitate motivation and readiness to cease tobacco use and engage in parental smoking cessation services.
The current computer program focuses on the assessment of the participant's smoking behavior and the delivery of personalized feedback regarding their smoking behavior.
Modifications to the new program will include the removal of the carbon monoxide testing, inclusion of all baseline and follow-up assessment into the computer-based program (creating a single, stand-alone package that further reduces staff burden), and the inclusion of a link directly to the Oklahoma Tobacco Settlement Endowment Trust "click to call" option (allowing patients to immediately self-refer for cessation support).
Parents of children presenting to a general pediatric outpatient clinic, who self-report as current smokers, will be recruited for a randomized controlled trial to assess the effectiveness of the revised computer-based program.
It is proposed that exposure to this brief intervention will result in increasing smokers' readiness to cease tobacco use and engage in smoking cessation services.
The successful completion of the proposed project will result in the development of a smoking cessation intervention that can be easily and consistently delivered, in a host of different settings, with little burden to existing staff.
The successful development of such an intervention directly relates to the OTRC Mission and Goals and specifically fits with two of the OTRC's primary research areas: prevention and cessation of tobacco use and tobacco-related health disparities in Oklahoma's diverse populations and reduction of secondhand smoke exposure.
Study Type
Interventional
Phase
- Not Applicable
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the parent or caregiver reports active cigarette use
- the parent or caregiver speaks English as their primary language
Exclusion Criteria:
- the parent or caregiver is actively attempting smoking cessation
- the parent or caregiver reads below the 8th grade level
- the parent or caregiver does not have email or web access
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Personalized Feedback
The interactive program will provide assessment and personalized feedback on the participants' level of nicotine dependence, daily cigarette consumption, money spent on cigarettes, behavioral consequences of smoking, individual medical consequences of smoking, and family members' medical consequences of secondhand smoke.
|
The interactive program will provide assessment and personalized feedback on the participants' level of nicotine dependence, daily cigarette consumption, money spent on cigarettes, behavioral consequences of smoking, individual medical consequences of smoking, and family members' medical consequences of secondhand smoke.
|
Sham Comparator: Treatment as Usual
Practitioners are able to provide normal care with regard to smoking; participants will complete the Treatment Fidelity Questionnaire to assess whether any smoking cessation interventions occurred.
|
Practitioners are able to provide normal care with regard to smoking; participants will complete the Treatment Fidelity Questionnaire to assess whether any smoking cessation interventions occurred
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stage of Change
Time Frame: Baseline, 1- Mo Follow-up
|
The Stages of Change Algorithm (SCA; DiClemente et al., 1991) will be used to categorize participants' individual stage of change in regards to smoking cessation.
Participants will be asked, "Are you thinking of quitting smoking?" and then placed into one of the following stages: (1) Precontemplation, "No, I am not seriously considering quitting within the next 6 months"; (2) Contemplation, "Yes, I am seriously considering quitting within the next 6 months"; or (3) Preparation, "Yes, I am seriously planning to quit within the next 30 days."
|
Baseline, 1- Mo Follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readiness to Quit
Time Frame: Baseline, 1-Mo Follow-up
|
The Contemplation Ladder (CL; Biener & Abrams, 1991) is a one-item instrument that provides a continuous measure of an individual's readiness to consider smoking cessation.
Participants view a ladder with rungs and text ranging from 0 "No thought of quitting," to 5 "Think I should quit but am not ready," to 10 "Taking action to quit (e.g., cutting down, enrolling in a program).
|
Baseline, 1-Mo Follow-up
|
Personal Importance, Confidence, and Motivation to Stop Smoking
Time Frame: Baseline; 1-Mo Follow-up
|
Participant perception of importance, confidence, and motivation to cease tobacco use will each be measured by an 11-point rating scale, ranging from 0 (not at all) to 10 (very).
Based on the stages of change model of behavior change and motivational interviewing, these three constructs are considered instrumental in assessing behavior change.
The proposed format for assessing these key constructs is consistent with the typical assessment strategy used while conducting motivational interviewing (Miller & Rollnick, 2002).
|
Baseline; 1-Mo Follow-up
|
Quit Behaviors
Time Frame: Baseline; 1-Mo follow-up
|
At baseline, all participants will be asked whether they have: (1)previously quit smoking; (2)previously engaged in a quit attempt; (3) methods used to quit smoking; and (4) the length of any previous cessation periods.
Additionally, during the follow-up participants will be asked whether they done any of the following since completing the program: (1) quit smoking; (2) engaged in a quit attempt; and (3) methods used to quit smoking; and (4) the length of the current smoking cessation period.
|
Baseline; 1-Mo follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen R Gillaspy, PhD, University of Oklahoma
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
June 1, 2010
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
March 8, 2011
First Submitted That Met QC Criteria
March 29, 2011
First Posted (Estimate)
March 30, 2011
Study Record Updates
Last Update Posted (Actual)
April 20, 2017
Last Update Submitted That Met QC Criteria
April 18, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1694
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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