Study Stopped
Despite efforts to recruit and enroll adolescents, identifying cigarette and e-cigarette users proved challenging. The study team was unable to meet the recruitment goal of 60 adolescents.
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
2 other identifiers
interventional
15
1 country
1
Brief Summary
More than 90% of adult smokers initiate tobacco use before age 18, making prevention and treatment of adolescent smoking a critical health priority. Behavioral economic interventions utilizing financial incentives can promote smoking cessation in adult populations. No studies have evaluated financial incentives among adolescents to promote engagement in effective tobacco cessation programs through primary care settings. The goal of this study is to to compare, through a pilot, randomized controlled trial, an intervention incentivizing contact with a tobacco cessation program (the Quitline), an intervention incentivizing quitting, or no financial incentive intervention on adolescent smoker enrollment and depth of engagement in the tobacco cessation program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedStudy Start
First participant enrolled
September 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2021
CompletedResults Posted
Study results publicly available
July 13, 2021
CompletedJuly 13, 2021
July 1, 2021
2.5 years
September 12, 2018
April 22, 2021
July 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Program Completion
Adolescent completion of the tobacco cessation program, defined as the proportion of tobacco users identified in the clinic that enroll, use, and complete the Quitline program compared across the 3 groups
10 weeks
Secondary Outcomes (1)
Confirmation of Tobacco Abstinence
10 weeks
Study Arms (3)
Quitline Incentive
EXPERIMENTALThe incentive structure emphasizes engaging with the Quitline Delivered Treatment, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the Quitline, for maintaining involvement in the Quitline program (per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the Way to Health (WTH) platform.
Tobacco Cessation Incentive
EXPERIMENTALThe incentive structure emphasizes quitting regardless of engagement with the Quitline Delivered Treatment (though the Quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, compensation for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the WTH platform.
No Financial Incentive
PLACEBO COMPARATORNo financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform.
Interventions
The incentive structure emphasizes engaging with the quitline, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the quitline, for maintaining involvement in the quitline program (compensation per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative cotinine swab).
The incentive payment structure emphasizes quitting regardless of engagement with the quitline (though the quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative cotinine swab).
The WTH platform is a web-based platform that sends reminder text messages to participants regarding study procedures and has has secure financial tracking and processing systems to manage participant payments, including the ability to track earnings and pay participants via a non-integrated payment system.
The quitline provides tobacco cessation treatment to individuals who enroll in treatment. This treatment includes 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between proactive calls.
Eligibility Criteria
You may qualify if:
- Adolescents (aged 14-21 years), male or female, who speak English, screen positive for tobacco use (defined as having smoked cigarette(s) and/or used an e-cigarette product on at least 1 day during the 30 days before the clinical encounter) during their routine well child or acute visit, are interested in quitting, have a smart phone, and provide assent to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Philadelphia, Care Network
Philadelphia, Pennsylvania, 19146, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We were unable to reach our enrollment goal of 60 adolescents due to trouble recruiting.
Results Point of Contact
- Title
- Dr. Brian Jenssen
- Organization
- Children's Hospital of Philadelphia
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Jenssen, MD
Children's Hospital of Philadelphia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2018
First Posted
September 13, 2018
Study Start
September 21, 2018
Primary Completion
March 19, 2021
Study Completion
March 19, 2021
Last Updated
July 13, 2021
Results First Posted
July 13, 2021
Record last verified: 2021-07