ClinicalTrials.gov
ClinicalTrials.gov Menu

Tobacco Dependence Treatment Education for Dental Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01522924
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : August 22, 2013
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Jacqueline A. Singleton, University of Louisville

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Smoking
Intervention Other: Counseling practice sessions
Enrollment 94

Recruitment Details The recruitment period began on February 23 and ended on April 19. The location of the study was at a dental school and the standardized patient clinic in the medical school.
Pre-assignment Details Students were excluded from the study if they did not meet study requirements.
Arm/Group Title Counseling Practice Sessions Lecture Only
Hide Arm/Group Description 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. Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Period Title: Overall Study
Started 42 [1] 52 [2]
Completed 42 [3] 52 [4]
Not Completed 0 0
[1]
There were 42 dental students in the intervention group.
[2]
There were 52 dental students in the control group.
[3]
There were 42 dental students who completed the second survey after the intervention.
[4]
There were 52 dental students who completed the second survey after the lecture.
Arm/Group Title Counseling Practice Sessions Lecture Only Total
Hide Arm/Group Description 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. Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture Total of all reporting groups
Overall Number of Baseline Participants 42 52 94
Hide Baseline Analysis Population Description
There were 94 dental students who provided linkable surveys. There were 42 in the intervention group and 52 in the control group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 52 participants 94 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
52
 100.0%
94
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 52 participants 94 participants
25.66  (4.31) 25.00  (3.74) 25.29  (3.99)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 52 participants 94 participants
Female 12 23 35
Male 29 29 58
[1]
Measure Description: Missing data on one participant. Data is unknown.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 52 participants 94 participants
42 52 94
1.Primary Outcome
Title Change From Baseline in Attitude Score
Hide Description 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.
Time Frame Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The control group (lecture only) completed the second questionnaire after the lecture and the intervention group (counseling practice sessions) completed the second questionnaire after the counseling practice sessions and the debriefing session.
Arm/Group Title Counseling Practice Sessions Lecture Only
Hide Arm/Group Description:
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.
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Overall Number of Participants Analyzed 42 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
.64  (2.61) -.25  (2.27)
2.Primary Outcome
Title Change From Baseline in Perceived Barriers Score
Hide Description 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.
Time Frame Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by completing the second questionnaire after the lecture or after the counseling practice sessions using standardized patients.
Arm/Group Title Counseling Practice Sessions Lecture Only
Hide Arm/Group Description:
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.
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Overall Number of Participants Analyzed 42 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.83  (1.53) .87  (1.78)
3.Primary Outcome
Title Change From Baseline in Subjective Norms Score
Hide Description 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.
Time Frame Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by the completing the questionnaire after the lecture or after the counseling practice sessions using standardized patients.
Arm/Group Title Counseling Practice Sessions Lecture Only
Hide Arm/Group Description:
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.
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Overall Number of Participants Analyzed 42 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.55  (4.73) .67  (3.42)
4.Primary Outcome
Title Change From Baseline in Perceived Skills Score
Hide Description 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.
Time Frame Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Counseling Practice Sessions Lecture Only
Hide Arm/Group Description:
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.
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Overall Number of Participants Analyzed 42 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.52  (6.62) 3.38  (4.84)
5.Primary Outcome
Title Change From Baseline in Self-efficacy Score
Hide Description 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.
Time Frame Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Counseling Practice Sessions Lecture Only
Hide Arm/Group Description:
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.
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Overall Number of Participants Analyzed 42 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.34  (8.61) 7.66  (6.90)
6.Primary Outcome
Title Change From Baseline in Intentions Score
Hide Description 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.
Time Frame Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Counseling Practice Sessions Lecture Only
Hide Arm/Group Description:
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.
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Overall Number of Participants Analyzed 42 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.88  (9.05) 1.90  (6.96)
7.Primary Outcome
Title Change From Baseline in Tobacco Cessation Knowledge Score
Hide Description 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.
Time Frame Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Counseling Practice Sessions Lecture Only
Hide Arm/Group Description:
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.
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Overall Number of Participants Analyzed 42 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.55  (2.98) 2.60  (2.77)
Time Frame 3 months
Adverse Event Reporting Description Serious and nonserious adverse events were not collected for either arm of the study.
 
Arm/Group Title Lecture Only Counseling/Debriefing
Hide Arm/Group Description participated in lecture only participated in counseling and debriefing sessions
All-Cause Mortality
Lecture Only Counseling/Debriefing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lecture Only Counseling/Debriefing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lecture Only Counseling/Debriefing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
One participant in the intervention group did not provide gender information. The total number of participants in the intervention group did not equal the number of male and female participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jacqueline Singleton
Organization: University of Louisville
Phone: 502-852-2611
Responsible Party: Jacqueline A. Singleton, University of Louisville
ClinicalTrials.gov Identifier: NCT01522924     History of Changes
Other Study ID Numbers: 12.0026
First Submitted: January 24, 2012
First Posted: February 1, 2012
Results First Submitted: January 7, 2013
Results First Posted: August 22, 2013
Last Update Posted: May 23, 2017