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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00554 | Registry Identifier | NCI CTRP | |
| 1K99DA044277-01A1 | U.S. NIH Grant/Contract | View source | |
| IRB201903082 | Other Identifier | University of Florida IRB | |
| R00DA044277 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASPIRE Group | Experimental | 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 (assessment 8). |
|
| GSA-ASPIRE-Network Group | Experimental | 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 of the intervention, and about one month after the intervention has ended (assessment 4), participants complete psychosocial surveys and social network surveys. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
-When participants don't meet the inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Georges Khalil, MPH, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39499912 | Derived | Khalil G, Ramirez E, Khan M, Zhao B, Ribeiro N, Balian P. Risk Perception and Knowledge Following a Social Game-Based Tobacco Prevention Program for Adolescents: Pilot Randomized Comparative Trial. JMIR Serious Games. 2024 Nov 5;12:e63296. doi: 10.2196/63296. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Assignment to Baseline |
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| Recruitment Period for Assessment 5 |
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| Recruitment to Assessment 5 |
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| Assessment 5 to Second Post-test |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 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. |
|
4 months
At each session of data collection or intervention, the study staff were asked to record any adverse event that may occur, including a brief explanation of the event, when it occurred, the date of the event, description of what occurred, actions taken by research staff, planned follow up (if any), the intervention group/study arm of the affected participant, whether the event appears to be related to the intervention, and whether the participant will continue in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This study faced some limitations including a low retention rate due to the timing of data collection, a lack of long-term behavioral data, and the reliance on staff for program delivery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor | University of Florida | 3526279467 | gkhalil@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2022 | Aug 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2022 | Aug 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005106 | Exploratory Behavior |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Participants will not know if they are receiving the intervention to be tested or the comparative intervention.
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| ASPIRE | Behavioral | 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. |
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| GSA-ASPIRE-Network | Behavioral | 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. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Number analyzed differs from overall because 74 participants did not answer the question. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Susceptible to using tobacco | Using the original measure of susceptibility while considering several tobacco products including e-cigarettes, cigarettes, cigars, hookah, and chewing tobacco. Pierce JP, Choi WS, Gilpin EA, Farkas AJ, Merritt RK. Validation of susceptibility as a predictor of which adolescents take up smoking in the United States. Health psychology. 1996 Sep;15(5):355. | The row population differs from the overall number because some participants did not answer these survey questions. | Count of Participants | Participants |
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| OG001 | 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. |
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| 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. | 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. | Posted | Count of Participants | Participants | 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. |
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|
|
| 0 |
| 153 |
| 0 |
| 153 |
| 0 |
| 153 |
| EG001 | 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. | 0 | 240 | 0 | 240 | 0 | 240 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| 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). | Mixed Models Analysis | <0.01 | Odds Ratio (OR) | 0.13 | 2-Sided | 95 | 0.04 | 0.40 | Superiority |