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Computer-Based Program to Facilitate Readiness and Motivation for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01326234
Recruitment Status : Withdrawn (Due to staff changes the study never started.)
First Posted : March 30, 2011
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Stephen Gillaspy, University of Oklahoma

March 8, 2011
March 30, 2011
April 20, 2017
June 2010
November 2014   (Final data collection date for primary outcome measure)
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."
Stage of Change [ Time Frame: Baseline, 1- and 6-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."
Complete list of historical versions of study NCT01326234 on ClinicalTrials.gov Archive Site
  • 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).
  • 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).
  • 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.
  • Readiness to Quit [ Time Frame: Baseline, 1- and 6-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).
  • Personal Importance, Confidence, and Motivation to Stop Smoking [ Time Frame: Baseline; 1- and 6-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).
  • Quit Behaviors [ Time Frame: Baseline; 1- and 6-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.
Not Provided
Not Provided
 
Computer-Based Program to Facilitate Readiness and Motivation for Smoking Cessation
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Smoking
  • Behavioral: 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.
  • Behavioral: 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
  • 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.
    Intervention: Behavioral: Personalized Feedback
  • 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.
    Intervention: Behavioral: Treatment as Usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
150
November 2014
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. the parent or caregiver reports active cigarette use
  2. the parent or caregiver speaks English as their primary language

Exclusion Criteria:

  1. the parent or caregiver is actively attempting smoking cessation
  2. the parent or caregiver reads below the 8th grade level
  3. the parent or caregiver does not have email or web access
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01326234
1694
Yes
Not Provided
Not Provided
Stephen Gillaspy, University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Stephen R Gillaspy, PhD University of Oklahoma
University of Oklahoma
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP