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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Oklahoma.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Stephen Gillaspy, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01326234
First received: March 8, 2011
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Smoking
Behavioral: Personalized Feedback
Behavioral: Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Further Development and Testing of an Interactive Computer-Based Program to Facilitate Readiness and Motivation for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Stage of Change [ Time Frame: Baseline, 1- Mo Follow-up ] [ Designated as safety issue: No ]
    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."


Secondary Outcome Measures:
  • Readiness to Quit [ Time Frame: Baseline, 1-Mo Follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Treatment as Usual
No formal smoking cessation plan.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326234

Contacts
Contact: Stephen R Gillaspy, PhD 405-271-4407 stephen-gillaspy@ouhsc.edu

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Steven Gillaspy, PhD    405-271-4407    steven-gillaspy@ouhsc.edu   
Contact: Kathy J Kyler, MS    405-271-8001 ext 44269    kathy-kyler@ouhsc.edu   
Principal Investigator: Stephen R Gillaspy, PhD         
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Stephen R Gillaspy, PhD University of Oklahoma
  More Information

No publications provided

Responsible Party: Stephen Gillaspy, Associate Professor, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01326234     History of Changes
Other Study ID Numbers: 15312
Study First Received: March 8, 2011
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Smoking
Motivation
Cessation

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 14, 2014