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Social Influence Strategies + ASPIRE for Smoking Prevention

N/A

Recruiting

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of ASPIRE to GSA-ASPIRE to Decrease Adolescents' Intention to Smoke

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

Surveys

2020

Completed Phase 1

~11070

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

714,887 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,469 Previous Clinical Trials

2,618,609 Total Patients Enrolled

31 Trials studying Tobacco Use

6,233 Patients Enrolled for Tobacco Use

Georges Khalil, MPH, PhDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this clinical trial limited to adults aged 18 and above?

"The lower threshold of age for inclusion in this experiment is 11, and the upper limit is 18."

Answered by AI

How many participants is this experiment assessing?

"Indeed, the records on clinicaltrials.gov reveal that this research is currently in a recruitment phase; it was first posted on June 1st 2021 and its most recent update came through October 4th 2022. 800 participants need to be enrolled from one site."

Answered by AI

Does this clinical study still accept participants?

"Affirmative. According to clinicaltrials.gov, this research endeavour is actively enlisting participants. It was initially published on June 1st 2021 and the most recent update was posted on October 4th 2022; 800 individuals are needed from a single medical center for the study to move forward."

Answered by AI

Do I fulfill the requirements to join this experiment?

"This clinical trial seeks 800 participants aged between 11 and 18, who use tobacco. To be eligible for the study, individuals must fulfill certain criteria; they need to speak English as their primary language, not have any developmental or physical disability that would inhibit them from participating (barring understanding of the consent document and ability to complete the board game/internet activities), and pregnant adolescents may take part in accordance with NIH standards."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Smoking Prevention Through Social Connections Among Adolescents - ASPIRE

2021. "Smoking Prevention Through Social Connections Among Adolescents - ASPIRE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02703597.

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