Tobacco Use BehaviorNCT02703597

Smoking Prevention Through Social Connections Among Adolescents - ASPIRE

A study testing Surveys, ASPIRE and GSA-ASPIRE-Network in people with Tobacco Use Behavior, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Use Behavior
What is being tested?: Surveys, ASPIRE and GSA-ASPIRE-Network
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 393 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2021to 16 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

-When participants don't meet the inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: 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.

Conditions: Tobacco Use Behavior
Being tested: Surveys, ASPIRE, GSA-ASPIRE-Network
Keywords: Tobacco, Curiosity, Tobacco Cessation, Tobacco Prevention, Health improvement, Smoking prevention interactive experience, ASPIRE, Games for health, Surveys, Questionnaires, Interviews, Focus Group
Medical subject headings: Exploratory Behavior, Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurveysBehavioural
Also called Questionnaires
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.
ASPIREBehavioural
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.
GSA-ASPIRE-NetworkBehavioural
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.

Study groups in NCT02703597
Study group	Role	What they receive
ASPIRE Group	Experimental	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). Receives: Behavioral: Surveys; Behavioral: ASPIRE
GSA-ASPIRE-Network Group	Experimental	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. Receives: Behavioral: Surveys; Behavioral: GSA-ASPIRE-Network

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202116 Mar 2022

First posted9 Mar 2016 (estimated)
Study start1 Jun 2021
Primary completion16 Mar 2022
Study completion16 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tobacco Use BehaviorStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 393 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02703597
Sponsor's protocol ID: 2015-0995
Other IDs: NCI-2016-00554, 1K99DA044277-01A1, IRB201903082, R00DA044277
Status last verified: Sep 2024
First submitted: 4 Mar 2016
Last updated: 23 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Khalil G, Ramirez E, Khan M, Zhao B, Ribeiro N, Balian P. Risk Perception and Knowledge Following a Social Game-Based Tobacco Prevention Program for Adolescents: Pilot Randomized Comparative Trial. JMIR Serious Games. 2024 Nov 5;12:e63296. doi: 10.2196/63296.
PubMed 39499912

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco Use Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Social Influence Strategies During a Web-based Smoking Prevention Intervention for Adolescents
ClinicalTrials.gov ID: NCT02703597
Acronym / sponsor ID: 2015-0995
Conditions: Tobacco Use Behavior
Keywords: Tobacco, Curiosity, Tobacco Cessation, Tobacco Prevention, Health improvement, Smoking prevention interactive experience, ASPIRE, Games for health
Study type: Interventional
Recruitment status: Completed
Enrolment: 393 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Jun 2021 (actual)
Primary completion: 16 Mar 2022 (actual)
Study completion: 16 Mar 2022 (actual)
First posted: 9 Mar 2016 (estimated)
Results: Posted 23 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
ASPIRE Group	Experimental	Behavioral: Surveys, Behavioral: ASPIREParticipants 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	Experimental	Behavioral: Surveys, Behavioral: GSA-ASPIRE-NetworkParticipants 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.

Who may qualify

Ages: 11 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (1 listed)

-When participants don't meet the inclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SurveysAlso: QuestionnairesSurveys 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.	Behavioural	ASPIRE Group, GSA-ASPIRE-Network Group
ASPIREParticipants 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.	Behavioural	ASPIRE Group
GSA-ASPIRE-NetworkIn 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.	Behavioural	GSA-ASPIRE-Network Group

Primary outcome

Susceptibility to Vaping
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 23 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ASPIRE Group	153	136
GSA-ASPIRE-Network Group	240	224

Primary outcome: Susceptibility to Vaping

Time frame: 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.. Count of participants. Unit: Participants

Measure	ASPIRE Group n = 137	GSA-ASPIRE-Network Group n = 229
Value	66	118

ASPIRE Group vs GSA-ASPIRE-Network Group: Odds Ratio (OR): 1.15 (95% CI 0.32 to 4.20), p = 0.80, Mixed Models Analysis
ASPIRE Group vs GSA-ASPIRE-Network Group: Odds Ratio (OR): 0.17 (95% CI 0.06 to 0.43), p <0.01, Mixed Models Analysis

Population analysed: All collected data for this pre-specified Primary Outcome Measure is summarized and reported in this table. The number of participants analyzed differs from overall because not all participants answered the outcome measure survey questions.

Primary outcome: Susceptibility to Using Conventional Tobacco

Measure	ASPIRE Group n = 136	GSA-ASPIRE-Network Group n = 229
Value	63	106

ASPIRE Group vs GSA-ASPIRE-Network Group: Odds Ratio (OR): 0.76 (95% CI 0.16 to 3.49), p = 0.70, Mixed Models Analysis
ASPIRE Group vs GSA-ASPIRE-Network Group: Odds Ratio (OR): 0.13 (95% CI 0.04 to 0.40), p <0.01, Mixed Models Analysis

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ASPIRE Group	0 of 153 (0%)	0 of 153 (0%)	0 of 153
GSA-ASPIRE-Network Group	0 of 240 (0%)	0 of 240 (0%)	0 of 240

Limitations and caveats (from the sponsor): This study faced some limitations including a low retention rate due to the timing of data collection, a lack of long-term behavioral data, and the reliance on staff for program delivery.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39499912Khalil G, Ramirez E, Khan M, Zhao B, Ribeiro N, Balian P. Risk Perception and Knowledge Following a Social Game-Based Tobacco Prevention Program for Adolescents: Pilot Randomized Comparative Trial. JMIR Serious Games. 2024 Nov 5;12:e63296. doi: 10.2196/63296.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Georges Khalil, MPH, PhD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Surveys, ASPIRE and GSA-ASPIRE-Network in people with Tobacco Use Behavior, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Susceptibility to Vaping (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02703597, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.