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SmokingNCT01326234

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

A study testing Personalized Feedback and Treatment as Usual in people with Smoking, run by University of Oklahoma.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking
What is being tested?
Personalized Feedback and Treatment as Usual
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2010to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • the parent or caregiver reports active cigarette use
  • the parent or caregiver speaks English as their primary language

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Conditions
Smoking
Being tested
Personalized Feedback, Treatment as Usual
Keywords
Smoking, Motivation, Cessation
Medical subject headings
Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized FeedbackBehavioural

    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.

  • Treatment as UsualBehavioural

    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

Study groups in NCT01326234
Study groupRoleWhat they receive
Personalized FeedbackActive comparatorThe 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.
Receives: Behavioral: Personalized Feedback
Treatment as UsualSham comparatorPractitioners 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.
Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stage of Change

    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."

    Measured: Baseline, 1- Mo Follow-up

Secondary outcomes (3)
  1. Readiness to Quit

    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).

    Measured: Baseline, 1-Mo Follow-up

  2. Personal Importance, Confidence, and Motivation to Stop Smoking

    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).

    Measured: Baseline; 1-Mo Follow-up

  3. Quit Behaviors

    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.

    Measured: Baseline; 1-Mo follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionNov 2014
  4. Study completionNov 2014

Why it stopped: Due to staff changes the study never started.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01326234
Sponsor's protocol ID
1694
Status last verified
Apr 2017
First submitted
8 Mar 2011
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Feedback and Treatment as Usual in people with Smoking, run by University of Oklahoma.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage of Change (time frame: Baseline, 1- Mo Follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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