Smoking Prevention Through Social Connections Among Adolescents - ASPIRE

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Behavior
• Intervention / Treatment: Behavioral: Surveys; Behavioral: ASPIRE; Behavioral: GSA-ASPIRE-Network

• Study Type: Interventional
• Enrollment (Actual): 393
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 (assessment 8).	Behavioral: 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.; Other Names: Questionnaires; Behavioral: 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.
Experimental: 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 of the intervention, and about one month after the intervention has ended (assessment 4), participants complete psychosocial surveys and social network surveys.	Behavioral: 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.; Other Names: Questionnaires; Behavioral: GSA-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Georges Khalil, MPH, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (Estimated): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Tobacco; Questionnaires; Surveys; Tobacco Cessation; Tobacco Prevention; Interviews; Focus Group; Curiosity; Health improvement; Smoking prevention interactive experience; ASPIRE; Games for health
• Other Study ID Numbers: 2015-0995; NCI-2016-00554 (Registry Identifier: NCI CTRP); 1K99DA044277-01A1 (U.S. NIH Grant/Contract); IRB201903082 (Other Identifier: University of Florida IRB); R00DA044277 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No