Smoking Prevention Through Social Connections Among Adolescents - ASPIRE

Not Applicable

Completed

• Conditions: Tobacco Use Behavior
• Interventions: Behavioral: Surveys; Behavioral: ASPIRE; Behavioral: GSA-ASPIRE-Network

• Registration Number: NCT02703597
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Study Start: 2021-06-01
• Primary Completion: 2022-03-16
• Study Completion: 2022-03-16
• Results First Submitted: 2024-08-29
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Results First Posted: 2024-10-23
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

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.

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Exclusion Criteria

-When participants don't meet the inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASPIRE Group	ASPIRE	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).
ASPIRE Group	Surveys	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	Surveys	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.
GSA-ASPIRE-Network Group	GSA-ASPIRE-Network	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States