Clinical trial NCT03670264: BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
Official title: BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-09-13
Enrollment: 15
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: Context:

Cigarette smoking remains a leading preventable cause of death in the United States (U.S.) with substantial morbidity, mortality, and financial costs each year. More than 90% of adult smokers initiate tobacco use before age 18, making prevention and treatment of adolescent tobacco use a critical health priority. Further, e-cigarettes are now the most common tobacco product used by teenagers, and adolescent use of e-cigarettes is strongly associated with transition to cigarette use. 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.

Objectives:

Primary Objective: To compare, through a pilot, randomized controlled trial, an intervention incentivizing contact with the Quitline, an intervention incentivizing quitting, or no financial incentive intervention on adolescent enrollment and depth of engagement in a tobacco cessation program (Free Smoker Quitline).

Secondary Objective: To compare cotinine-confirmed 2-month quit rates across the 3 groups, among users who report abstinence.

Study Design:

This is a randomized controlled trial of a Quitline incentive versus tobacco cessation incentive versus no financial incentive on adolescent engagement with a tobacco cessation program.

Setting/Participants:

Setting: Primary care sites within the Children's Hospital of Philadelphia (CHOP's) Pediatric Research Consortium along with other non-clinical community settings.

60 adolescent tobacco users will be recruited. Eligibility criteria include adolescents (aged 14-21 years), who speak English, screen positive for tobacco use during their routine well child or acute visit, are interested in quitting, and have a smart phone.

Study Interventions and Measures:

Adolescents will be randomized to 1 of 3 financial incentive groups: (1) Quitline Incentive: the payment structure emphasizes engaging with the Quitline, with an additional smaller payment for tobacco cessation; (2) Tobacco Cessation Incentive: the payment structure emphasizes quitting regardless of engagement with the quitline (though the quitline will be presented as a helpful tool); and (3) no financial incentive. The Quitline is funded by the Pennsylvania Department of Health and staffed by trained cessation counselors available 24 hours a day, 7 days a week.

Outcomes Measures: Objective 1: The main outcome of interest is 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. Objective 2: The secondary outcome is to confirm abstinence, via salivary cotinine concentration of \<30 ng per milliliter at 10 weeks after the start of the study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Subjects that do not meet all of the inclusion criteria will not be enrolled.

Primary outcomes:
measure: Program Completion
timeFrame: 10 weeks
Secondary outcomes:
measure: Confirmation of Tobacco Abstinence
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia, Care Network
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Brian Jenssen, MD
role: PRINCIPAL_INVESTIGATOR
References: