Smoking Prevention Through Social Connections Among Adolescents - ASPIRE

NCT ID: NCT02703597

Last Updated: 2024-10-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-03-16

Brief Summary

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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

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Conditions

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Tobacco Use Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants will not know if they are receiving the intervention to be tested or the comparative intervention.

Study Groups

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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).

Group Type EXPERIMENTAL

Surveys

Intervention Type BEHAVIORAL

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.

ASPIRE

Intervention Type BEHAVIORAL

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-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.

Group Type EXPERIMENTAL

Surveys

Intervention Type BEHAVIORAL

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.

GSA-ASPIRE-Network

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Questionnaires

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georges Khalil, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39499912 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2016-00554

Identifier Type: REGISTRY

Identifier Source: secondary_id

1K99DA044277-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201903082

Identifier Type: OTHER

Identifier Source: secondary_id

R00DA044277

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-0995

Identifier Type: -

Identifier Source: org_study_id

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