SmokingNCT01522924
Tobacco Dependence Treatment Education for Dental Students
A study testing Counseling practice sessions in people with Smoking, run by University of Louisville at 1 site in United States.
Trial summary
This study determines if there is a difference in dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge in those students receiving a tobacco cessation lecture along with practice sessions using standardized… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Counseling practice sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- must be a first year dental student in Introduction to Clinical Dentistry I at the study institution
- volunteer to complete pre- and post-questionnaires concerning tobacco cessation treatment educational training.
Who cannot join
- subject does not complete pre- and post- questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville School of Dentistry
Louisville, Kentucky, 40292
About this study
Official title: Tobacco Dependence Treatment Education for Dental Students Using Standardized Patients
This study determines if there is a difference in dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge in those students receiving a tobacco cessation lecture along with practice sessions using standardized patients and those students receiving only a tobacco cessation lecture. The study determines if dental students' use of tobacco affects their intent to provide cessation treatment to patients, and if the time between receiving the lecture and participating in the practice sessions using standardized patients makes a difference in dental students' attitudes, perceived barriers, subjective norms. perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge.
Read the detailed description
The experimental study has a pretest-posttest design. It evaluates the changes to dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and tobacco cessation knowledge between those students receiving a lecture along with practice sessions using standardized patients and those students receiving only a lecture. Dental students will be invited to complete two questionnaires. The control group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture. The experimental group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture and the practice and debriefing sessions. Subjects will include 120 first year dental students in an introductory course to clinical dentistry. The cessation training is a required activity in the course. Students are divided into small groups according to their bench or lab numbers. These numbers are assigned to the student based on the alphabetical order of their name. The eligibility criteria is: 1) Must be a first year dental student in Introduction to Clinical Dentistry 1 at the University of Louisville, and 2) Must be willing to volunteer to complete pre- and post-questionnaires about the cessation treatment educational program. The exclusion criteria is: Subject is not willing to give consent to complete the pre- and post- questionnaire.
- Conditions
- Smoking
- Being tested
- Counseling practice sessions
- Keywords
- tobacco cessation treatment, standardized patients, dental students, tobacco cessation treatment education
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling practice sessionsOther
Also called Tobacco cessation treatment education, Tobacco cessation counseling, Smoking cessation counseling, Tobacco dependence treatment
Dental students will complete the first questionnaire before a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients and a debriefing session.
| Study group | Role | What they receive |
|---|---|---|
| Counseling practice sessions | Experimental | Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session. Receives: Other: Counseling practice sessions |
| Lecture only | No intervention | Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Attitude Score
The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) "It is important for members of the profession to discuss tobacco use with patients" and 2.) "A brief intervention (3 minutes) for tobacco cessation with my patients would be effective." The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2.
Measured: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Change From Baseline in Perceived Barriers Score
The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.
Measured: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)
Change From Baseline in Subjective Norms Score
Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.
Measured: Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Change From Baseline in Perceived Skills Score
The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.
Measured: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Change From Baseline in Self-efficacy Score
Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.
Measured: Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Change From Baseline in Intentions Score
Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.
Measured: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Change From Baseline in Tobacco Cessation Knowledge Score
The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.
Measured: Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline A. Singleton, University of Louisville
- Investigators
- Jacqueline A Singleton, MEd, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522924
- Sponsor's protocol ID
- 12.0026
- Status last verified
- Apr 2017
- First submitted
- 24 Jan 2012
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Walsh SE, Singleton JA, Worth CT, Krugler J, Moore R, Wesley GC, Mitchell CK. Tobacco cessation counseling training with standardized patients. J Dent Educ. 2007 Sep;71(9):1171-8.
PubMed 17761623
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Dependence Treatment Education for Dental Students Using Standardized Patients
- ClinicalTrials.gov ID
- NCT01522924
- Acronym / sponsor ID
- 12.0026
- Conditions
- Smoking
- Keywords
- tobacco cessation treatment, standardized patients, dental students, tobacco cessation treatment education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 22 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study determines if there is a difference in dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge in those students receiving a tobacco cessation lecture along with practice sessions using standardized patients and those students receiving only a tobacco cessation lecture. The study determines if dental students' use of tobacco affects their intent to provide cessation treatment to patients, and if the time between receiving the lecture and participating in the practice sessions using standardized patients makes a difference in dental students' attitudes, perceived barriers, subjective norms. perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge.
Detailed description
The experimental study has a pretest-posttest design. It evaluates the changes to dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and tobacco cessation knowledge between those students receiving a lecture along with practice sessions using standardized patients and those students receiving only a lecture. Dental students will be invited to complete two questionnaires. The control group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture. The experimental group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture and the practice and debriefing sessions. Subjects will include 120 first year dental students in an introductory course to clinical dentistry. The cessation training is a required activity in the course. Students are divided into small groups according to their bench or lab numbers. These numbers are assigned to the student based on the alphabetical order of their name. The eligibility criteria is: 1) Must be a first year dental student in Introduction to Clinical Dentistry 1 at the University of Louisville, and 2) Must be willing to volunteer to complete pre- and post-questionnaires about the cessation treatment educational program. The exclusion criteria is: Subject is not willing to give consent to complete the pre- and post- questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling practice sessions | Experimental | Other: Counseling practice sessionsDental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session. |
| Lecture only | No intervention | –Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must be a first year dental student in Introduction to Clinical Dentistry I at the study institution
- volunteer to complete pre- and post-questionnaires concerning tobacco cessation treatment educational training.
Key exclusion criteria (1 listed)
- subject does not complete pre- and post- questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling practice sessionsAlso: Tobacco cessation treatment education, Tobacco cessation counseling, Smoking cessation counseling, Tobacco dependence treatmentDental students will complete the first questionnaire before a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients and a debriefing session. | Other | Counseling practice sessions |
Primary outcome
Change From Baseline in Attitude Score
Time frame: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) "It is important for members of the profession to discuss tobacco use with patients" and 2.) "A brief intervention (3 minutes) for tobacco cessation with my patients would be effective." The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2.
Change From Baseline in Perceived Barriers Score
Time frame: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)
The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.
Change From Baseline in Subjective Norms Score
Time frame: Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.
Change From Baseline in Perceived Skills Score
Time frame: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.
Change From Baseline in Self-efficacy Score
Time frame: Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.
Change From Baseline in Intentions Score
Time frame: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.
Change From Baseline in Tobacco Cessation Knowledge Score
Time frame: Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17761623Walsh SE, Singleton JA, Worth CT, Krugler J, Moore R, Wesley GC, Mitchell CK. Tobacco cessation counseling training with standardized patients. J Dent Educ. 2007 Sep;71(9):1171-8.
- American Cancer SocietyLink provided by the sponsor.
- American Dental AssociationLink provided by the sponsor.
- American Dental Hygienists' AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline A Singleton, MEd principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling practice sessions in people with Smoking, run by University of Louisville at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Attitude Score (time frame: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522924, which also lists 1 linked publication.
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 23 May 2017.