Smoking Prevention Through Social Connections Among Adolescents - ASPIRE

Study Overview
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Brief Summary
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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.

Official Title
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Social Influence Strategies During a Web-based Smoking Prevention Intervention for Adolescents

Conditions
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Tobacco Use Behavior

Intervention / Treatment
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* Behavioral: Surveys
* Behavioral: ASPIRE
* Behavioral: GSA-ASPIRE-Network


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASPIRE Group<br>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). | Behavioral: Surveys<br>* 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.<br>* Other names: Questionnaires;Behavioral: ASPIRE<br>* 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.<br>|
| Experimental: GSA-ASPIRE-Network Group<br>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. | Behavioral: Surveys<br>* 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.<br>* Other names: Questionnaires;Behavioral: GSA-ASPIRE-Network<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of ASPIRE to GSA-ASPIRE to Decrease Adolescents' Intention to Smoke | During the course of the study surveys reviewed. | 4 weeks | 
| Comparison of ASPIRE to GSA-ASPIRE to Decrease Adolescents' Intention to Smoke | During the course of the study audio recorded interviews reviewed. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, Curiosity, Tobacco Cessation, Tobacco Prevention, Health improvement, Smoking prevention interactive experience, ASPIRE, Games for health, Surveys, Questionnaires, Interviews, Focus Group