Tobacco Use Behavior
Conditions
Keywords
Tobacco, Curiosity, Tobacco Cessation, Tobacco Prevention, Health improvement, Smoking prevention interactive experience, ASPIRE, Games for health, Surveys, Questionnaires, Interviews, Focus Group
Brief summary
The central hypothesis of this study is that the addition of social influence strategies to a web-based program called ASPIRE will boost its success in lowering intention to use tobacco among adolescents and experiencing stronger positive social influence. The study will involve a nested group randomized controlled trial with adolescents from after-school programs and schools (e.g., the PK Yonge school) in Florida.
Interventions
BEHAVIORALSurveys
Surveys include questions related to tobacco use behavior and attitude toward tobacco, as well as demographic and personality questions. Psychosocial surveys and social network surveys are also completed to capture adolescents' network of friends and opinion leaders.
BEHAVIORALASPIRE
Participants engage in four to five 70-minute sessions of ASPIRE spread over a period of 4 weeks. During ASPIRE use, participants face a screen and individually watch videos and engage in computer-based activities related to the negative effects of tobacco.
BEHAVIORALGSA-ASPIRE-Network
In groups, participants engage in four to five 70-minute sessions of ASPIRE conducted over a period of 4 weeks. However, during each session, ASPIRE use is coupled with game-based social activities (GSAs). During ASPIRE use, participants watch videos and engage in computer-based activities on the same computer screen. Also, in groups, participants engage in the paper-based GSAs as a team and collaborate as they complete the activities. The GSAs contain games about the effects of tobacco. Groups are allocated based on adolescents' network of friendships.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will not know if they are receiving the intervention to be tested or the comparative intervention.
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* All participants must be of ages 11 through 18 (11 and 18 included; age group for adolescents adopted by several National Institutes of Health) * Are members of after school program or school * All participants will be English speaking * Adolescents with developmental disability, mental or physical, are not excluded from the study. However, they will only be able to participate if (1) they understand the information presented to them in the consent document, and (2) they believe they are capable to engage in the board game, use the internet, and answer survey questions. * Pregnant adolescents will be eligible to participate in the research study as requested by the NIH based on 2 principles that will be discussed at time of consent.
Exclusion criteria
-When participants don't meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Susceptibility to Vaping | 4 weeks; Note that each survey completion has a window of 2 weeks, taking into account site availability, presence of students, holidays, and site resources. | During the course of the study surveys reviewed. This outcome was measured using a binary form of the susceptibility to vaping scale, which aims at measuring intention to vape. Scores were 0 (non-susceptible) or 1 (susceptible). A score of 1 has a worse value than a score of 0. |
| Susceptibility to Using Conventional Tobacco | 4 weeks; Note that each survey completion has a window of 2 weeks, taking into account site availability, presence of students, holidays, and site resources. | During the course of the study surveys reviewed. This outcome was measured using a binary form of the susceptibility to smoking scale, which aims at measuring intention to use conventional tobacco. Scores were 0 (non-susceptible) or 1 (susceptible). A score of 1 has a worse value than a score of 0. The measure combines susceptibility to using cigarettes, cigars, hookah, and chewing tobacco. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ASPIRE Group Participants engage in up to five 70-minute sessions of ASPIRE spread over a period of 5 weeks. Each session completion has a window of 2 weeks, taking into account site availability, presence of students, holidays, and site resources. During ASPIRE use, participants face a screen and individually watch videos and engage in computer-based activities related to the negative effects of tobacco. At baseline, after 3 sessions, following the last session of the intervention, and about one month after the intervention has ended, participants complete psychosocial surveys and social network surveys. Baseline survey again completed. About one month after assessment 4, this group receives a 5th assessment followed by a hybrid version of the GSA-ASPIRE-Network program (moderated by Kahoot!). The group receives additional assessments after 3 sessions, following the last session of the program, and about one month after the program has ended.
Surveys: Surveys include questions related to tobacco use behavior and attitude toward tobacco, as well as demographic and personality questions. Psychosocial surveys and social network surveys are also completed to capture adolescents' network of friends and opinion leaders.
ASPIRE: Participants engage in four to five 70-minute sessions of ASPIRE spread over a period of 4 weeks. During ASPIRE use, participants face a screen and individually watch videos and engage in computer-based activities related to the negative effects of tobacco. | 153 |
| GSA-ASPIRE-Network Group Participants engage in five 70-minute sessions of ASPIRE conducted over a period of 5 weeks, with 2 booster sessions. Each session completion has a window of 2 weeks, taking into account site availability, presence of students, holidays, and site resources. ASPIRE use is coupled with game-based social activities (GSAs). ASPIRE use, participants watch videos and engage in activities on the same computer. Each session, participants will alternate between 10 minutes of ASPIRE use and 5-minute GSAs. Participants engage in the paper-based GSAs as a team and collaborate as they complete the activities. The GSAs contain games about the effects of tobacco. Groups are allocated based on adolescents' network of friendships. At baseline, after 3 sessions, following the last session intervention, and about one month after intervention, participants complete psychosocial surveys and social network surveys.
Surveys: Surveys include questions on tobacco use behavior, attitude toward tobacco, and demographic and personality questions. Psychosocial surveys and social network surveys are also completed to capture adolescents' network of friends and opinion leaders.
GSA-ASPIRE-Network Group: Participants engage in 4-5 weekly 70-minute ASPIRE sessions over 4 weeks, coupled with game-based social activities (GSAs). In groups, they watch videos, do computer activities, and collaborate on paper-based GSAs, which focus on tobacco's effects. Groups are formed based on adolescents' friendships. | 240 |
| Total | 393 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Assessment 5 to Second Post-test | Lost to Follow-up | 27 | 0 |
| Assignment to Baseline | Lost to Follow-up | 17 | 16 |
| Baseline to First Post-test | Lost to Follow-up | 61 | 92 |
| First Post-test to First Follow-up | Lost to Follow-up | 5 | 3 |
| First Post-test to First Follow-up | Site drop out | 0 | 58 |
| Recruitment Period for Assessment 5 | Were not expected to participate in this stage as per protocol | 0 | 71 |
| Recruitment Period for Assessment 5 | Withdrawal by Site | 16 | 0 |
Baseline characteristics
| Characteristic | ASPIRE Group | Total | GSA-ASPIRE-Network Group |
|---|---|---|---|
| Age, Continuous | 13.09 years STANDARD_DEVIATION 1.5 | 13.26 years STANDARD_DEVIATION 1.42 | 13.36 years STANDARD_DEVIATION 1.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 61 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 268 Participants | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 17 Participants | 64 Participants | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 212 Participants | 109 Participants |
| Race (NIH/OMB) More than one race | 19 Participants | 38 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 66 Participants | 47 Participants |
| Race (NIH/OMB) White | 8 Participants | 60 Participants | 52 Participants |
| Sex: Female, Male Female | 70 Participants | 163 Participants | 93 Participants |
| Sex: Female, Male Male | 63 Participants | 156 Participants | 93 Participants |
| Susceptible to using tobacco | 80 Participants | 212 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 153 | 0 / 240 |
| other Total, other adverse events | 0 / 153 | 0 / 240 |
| serious Total, serious adverse events | 0 / 153 | 0 / 240 |
Outcome results
Primary
Susceptibility to Using Conventional Tobacco
During the course of the study surveys reviewed. This outcome was measured using a binary form of the susceptibility to smoking scale, which aims at measuring intention to use conventional tobacco. Scores were 0 (non-susceptible) or 1 (susceptible). A score of 1 has a worse value than a score of 0. The measure combines susceptibility to using cigarettes, cigars, hookah, and chewing tobacco.
Time frame: 4 weeks; Note that each survey completion has a window of 2 weeks, taking into account site availability, presence of students, holidays, and site resources.
Population: All collected data for this pre-specified Primary Outcome Measure is summarized and reported in this table. The number of participants analyzed differs from overall because not all participants answered the outcomes measure survey questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ASPIRE Group | Susceptibility to Using Conventional Tobacco | 63 Participants |
| GSA-ASPIRE-Network Group | Susceptibility to Using Conventional Tobacco | 106 Participants |
Comparison: Hypothesis: Adolescents who participated in the GSA-ASPIRE-Network group will be more likely to decrease in susceptibility to using conventional tobacco than adolescents who participated in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time).p-value: 0.795% CI: [0.16, 3.49]Mixed Models Analysis
Comparison: Hypothesis: Participants in both arms will decrease in susceptibility of using conventional tobacco over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time).p-value: <0.0195% CI: [0.04, 0.4]Mixed Models Analysis
Primary
Susceptibility to Vaping
During the course of the study surveys reviewed. This outcome was measured using a binary form of the susceptibility to vaping scale, which aims at measuring intention to vape. Scores were 0 (non-susceptible) or 1 (susceptible). A score of 1 has a worse value than a score of 0.
Time frame: 4 weeks; Note that each survey completion has a window of 2 weeks, taking into account site availability, presence of students, holidays, and site resources.
Population: All collected data for this pre-specified Primary Outcome Measure is summarized and reported in this table. The number of participants analyzed differs from overall because not all participants answered the outcome measure survey questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ASPIRE Group | Susceptibility to Vaping | 66 Participants |
| GSA-ASPIRE-Network Group | Susceptibility to Vaping | 118 Participants |
Comparison: Hypothesis: Participants in the GSA-ASPIRE-Network Group will be more likely to decrease in susceptibility to vaping than participants in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time).p-value: 0.895% CI: [0.32, 4.2]Mixed Models Analysis
Comparison: Hypothesis: Participants in both arms will decrease in susceptibility to vaping over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time).p-value: <0.0195% CI: [0.06, 0.43]Mixed Models Analysis