Smoking Prevention Through Social Connections Among Adolescents - ASPIRE

NCT02703597 | Completed Results

• 5 other identifiers: 2015-0995NCI-2016-005541K99DA044277-01A1IRB201903082R00DA044277
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Tobacco; Curiosity; Tobacco Cessation; Tobacco Prevention; Health improvement; Smoking prevention interactive experience; ASPIRE; Games for health; Surveys; Questionnaires; Interviews; Focus Group

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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).

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.

Behavioral: Surveys; Behavioral: GSA-ASPIRE-Network

Interventions

Surveys 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.

Also known as: Questionnaires

ASPIRE Group; GSA-ASPIRE-Network Group

ASPIRE 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.

ASPIRE Group

GSA-ASPIRE-Network 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.

GSA-ASPIRE-Network Group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 39499912 DERIVED

MeSH Terms

Conditions

Exploratory Behavior; Tobacco Use Cessation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

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.

Results Point of Contact

• Title: Assistant Professor
• Organization: University of Florida

gkhalil@ufl.edu

3526279467

Study Officials

• Georges Khalil, MPH, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if they are receiving the intervention to be tested or the comparative intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: June 1, 2021
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)