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Social Influence Strategies + ASPIRE for Smoking Prevention

N/A
Waitlist Available
Led By Georges Khalil, MPH, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants will be English speaking
All participants must be of ages 11 through 18 (11 and 18 included; age group for adolescents adopted by several National Institutes of Health)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether adding social influence strategies to an existing web-based program will make it more successful in reducing adolescents' intention to use tobacco and increasing positive social influence.

Who is the study for?
This trial is for adolescents aged 11-18 who are part of an after-school program or school in Florida, speak English, and can understand consent information. It includes those with developmental disabilities if they can engage in activities and answer surveys. Pregnant teens may join following specific NIH principles.
What is being tested?
The study tests whether adding social influence strategies to the ASPIRE web-based program helps reduce the intention to use tobacco among young people. Participants will be randomly placed into groups within their programs or schools to either receive ASPIRE alone or with added social network strategies.
What are the potential side effects?
Since this trial involves a behavioral intervention rather than medication, traditional physical side effects are not expected. However, participants might experience discomfort while discussing personal habits or when dealing with peer pressure during group activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I speak English.
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I am between 11 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Susceptibility to Using Conventional Tobacco
Susceptibility to Vaping

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: GSA-ASPIRE-Network GroupExperimental Treatment2 Interventions
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.
Group II: ASPIRE GroupExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASPIRE
2021
N/A
~400
GSA-ASPIRE-Network
2021
N/A
~400
Surveys
2020
Completed Phase 1
~11460

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,395 Previous Clinical Trials
766,899 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,579 Previous Clinical Trials
3,316,532 Total Patients Enrolled
35 Trials studying Tobacco Use
11,545 Patients Enrolled for Tobacco Use
Georges Khalil, MPH, PhDPrincipal InvestigatorUniversity of Florida
~89 spots leftby Nov 2025