Trial Outcomes & Findings for Smoking Prevention Through Social Connections Among Adolescents - ASPIRE (NCT NCT02703597)
NCT ID: NCT02703597
Last Updated: 2024-10-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
393 participants
Primary outcome timeframe
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.
Results posted on
2024-10-23
Participant Flow
Unit of analysis: after school programs
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Assignment to Baseline
STARTED
|
153 7
|
240 8
|
|
Assignment to Baseline
COMPLETED
|
136 7
|
224 8
|
|
Assignment to Baseline
NOT COMPLETED
|
17 0
|
16 0
|
|
Baseline to First Post-test
STARTED
|
136 7
|
224 8
|
|
Baseline to First Post-test
COMPLETED
|
75 7
|
132 8
|
|
Baseline to First Post-test
NOT COMPLETED
|
61 0
|
92 0
|
|
First Post-test to First Follow-up
STARTED
|
75 7
|
132 8
|
|
First Post-test to First Follow-up
COMPLETED
|
70 7
|
71 7
|
|
First Post-test to First Follow-up
NOT COMPLETED
|
5 0
|
61 1
|
|
Recruitment Period for Assessment 5
STARTED
|
70 7
|
71 7
|
|
Recruitment Period for Assessment 5
COMPLETED
|
54 4
|
0 0
|
|
Recruitment Period for Assessment 5
NOT COMPLETED
|
16 3
|
71 7
|
|
Recruitment to Assessment 5
STARTED
|
54 4
|
0 0
|
|
Recruitment to Assessment 5
COMPLETED
|
54 4
|
0 0
|
|
Recruitment to Assessment 5
NOT COMPLETED
|
0 0
|
0 0
|
|
Assessment 5 to Second Post-test
STARTED
|
54 4
|
0 0
|
|
Assessment 5 to Second Post-test
COMPLETED
|
27 4
|
0 0
|
|
Assessment 5 to Second Post-test
NOT COMPLETED
|
27 0
|
0 0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
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
Withdrawal by Site
|
16
|
0
|
|
Recruitment Period for Assessment 5
Were not expected to participate in this stage as per protocol
|
0
|
71
|
|
Assessment 5 to Second Post-test
Lost to Follow-up
|
27
|
0
|
Baseline Characteristics
Number analyzed differs from overall because 74 participants did not answer the question.
Baseline characteristics by cohort
| Measure |
ASPIRE Group
n=153 Participants
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.
|
GSA-ASPIRE-Network Group
n=240 Participants
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.
|
Total
n=393 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.09 years
STANDARD_DEVIATION 1.50 • n=153 Participants
|
13.36 years
STANDARD_DEVIATION 1.36 • n=240 Participants
|
13.26 years
STANDARD_DEVIATION 1.42 • n=393 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=133 Participants • Number analyzed differs from overall because 74 participants did not answer the question.
|
93 Participants
n=186 Participants • Number analyzed differs from overall because 74 participants did not answer the question.
|
163 Participants
n=319 Participants • Number analyzed differs from overall because 74 participants did not answer the question.
|
|
Sex: Female, Male
Male
|
63 Participants
n=133 Participants • Number analyzed differs from overall because 74 participants did not answer the question.
|
93 Participants
n=186 Participants • Number analyzed differs from overall because 74 participants did not answer the question.
|
156 Participants
n=319 Participants • Number analyzed differs from overall because 74 participants did not answer the question.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=153 Participants
|
42 Participants
n=240 Participants
|
61 Participants
n=393 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=153 Participants
|
151 Participants
n=240 Participants
|
268 Participants
n=393 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=153 Participants
|
47 Participants
n=240 Participants
|
64 Participants
n=393 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=153 Participants
|
5 Participants
n=240 Participants
|
6 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=153 Participants
|
5 Participants
n=240 Participants
|
5 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=153 Participants
|
3 Participants
n=240 Participants
|
6 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Black or African American
|
103 Participants
n=153 Participants
|
109 Participants
n=240 Participants
|
212 Participants
n=393 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=153 Participants
|
52 Participants
n=240 Participants
|
60 Participants
n=393 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=153 Participants
|
19 Participants
n=240 Participants
|
38 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=153 Participants
|
47 Participants
n=240 Participants
|
66 Participants
n=393 Participants
|
|
Susceptible to using tobacco
|
80 Participants
n=136 Participants • The row population differs from the overall number because some participants did not answer these survey questions.
|
132 Participants
n=229 Participants • The row population differs from the overall number because some participants did not answer these survey questions.
|
212 Participants
n=365 Participants • The row population differs from the overall number because some participants did not answer these survey questions.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
ASPIRE Group
n=137 Participants
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.
|
GSA-ASPIRE-Network Group
n=229 Participants
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.
|
|---|---|---|
|
Susceptibility to Vaping
|
66 Participants
|
118 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
ASPIRE Group
n=136 Participants
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.
|
GSA-ASPIRE-Network Group
n=229 Participants
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.
|
|---|---|---|
|
Susceptibility to Using Conventional Tobacco
|
63 Participants
|
106 Participants
|
Adverse Events
ASPIRE Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GSA-ASPIRE-Network Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place